Trial Outcomes & Findings for Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (NCT NCT04101357)

Last Updated: 2025-03-18

Results Overview

DLTs were defined as any non-immune-related adverse events (AEs) or immune-related AEs during the first treatment cycle that was of Grade 3 and that did not resolve to Grade 1 or lower within a week, or that were of Grade 4. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0), where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Cycle 1 (21 Days)

Results posted on

2025-03-18

Participant Flow

The trial was planned with three parts: Part 1A, Part 1B, and Part 2. Part 2, which was planned to consist of expansion cohorts in solid tumors was not conducted as the trial was terminated prematurely.

Participant milestones

Participant milestones
Measure	Part 1A: BNT411 Monotherapy: Dose Level (DL) 1: 0.05 mcg/kg Participants received BNT411 at a starting dose of 0.05 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable adverse events (AEs), withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Overall Study STARTED	2	1	1	3	4	15	9	6	6	3	4
Overall Study Safety Set	2	1	1	3	4	14	8	6	6	3	4
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	2	1	1	3	4	15	9	6	6	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1A: BNT411 Monotherapy: Dose Level (DL) 1: 0.05 mcg/kg Participants received BNT411 at a starting dose of 0.05 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable adverse events (AEs), withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Overall Study Death	1	1	1	2	4	11	4	4	5	2	3
Overall Study Trial closure	0	0	0	0	0	2	2	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	1	0	0	0	1	0	0	0
Overall Study Withdrawal by Subject	1	0	0	0	0	0	0	0	1	1	0
Overall Study Other	0	0	0	0	0	1	2	1	0	0	0
Overall Study Enrolled but not treated	0	0	0	0	0	1	1	0	0	0	0

Baseline Characteristics

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=8 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	11 Participants n=8 Participants	6 Participants n=8 Participants	5 Participants n=24 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	37 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	15 Participants n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	5 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	24 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	28 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	14 Participants n=8 Participants	8 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	49 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=8 Participants	8 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	45 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Not Reportable	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 Days)

Population: Analysis was performed on DLT evaluable set that included participants who received at least one dose of BNT411 and have completed the DLT evaluation period and meet the minimum exposure criterion or have experienced a DLT during the DLT evaluation period (Cycle 1).

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=3 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=10 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=6 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=5 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=2 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=3 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Baseline until 60 days after last dose of study treatment (3 years and 11 months)

Population: Analysis was performed on safety set that included all participants who received at least one dose of BNT411.

A TEAE was defined as any AE with an onset date on or after the first administration of trial treatment (if AE was absent before the first administration of trial treatment) or worsened after the first administration of trial treatment (if AE was present before the first administration of trial treatment). AEs occurring more than 60 days after last treatment administration were considered as treatment-emergent only if assessed as related to the trial treatment by the investigator. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition. AE were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=8 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs Related TEAE	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	13 Participants	7 Participants	6 Participants	6 Participants	3 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs TESAE	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	5 Participants	3 Participants	4 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs Related TESAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs TESAE leading to Death	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs TEAE	2 Participants	1 Participants	1 Participants	3 Participants	4 Participants	14 Participants	8 Participants	6 Participants	6 Participants	3 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs Grade >=3 TEAE	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants	3 Participants	3 Participants	5 Participants	5 Participants	3 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs Related Grade >=3 TEAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	3 Participants	5 Participants	3 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (TESAEs) and Grade >=3 TEAEs Related TESAE leading to Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Baseline until 60 days after last dose of study treatment (3 years and 11 months)

Population: Analysis was performed on safety set.

Participants with dose reduction and/or discontinuation of BNT411 due to TEAEs are reported.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=8 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Number of Participants Reporting Dose Reduction and/or Discontinuation of BNT411 Due to TEAEs Discontinuation of BNT411 due to TEAEs	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Participants Reporting Dose Reduction and/or Discontinuation of BNT411 Due to TEAEs Dose Reduction of BNT411	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	3 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 days)

Population: Analysis was performed on DLT evaluable set. Data for this outcome measure was planned to be analyzed and reported for all participants collectively.

The MTD defined as the highest tolerated dose was reported based on the DLTs and TEAEs experienced by participants.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=42 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Maximal Tolerated Dose (MTD) of BNT411	6.0 microgram/kilogram (mcg/kg)	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 (21 days)

Population: Analysis was performed on DLT evaluable population. Data for this outcome measure was planned to be analyzed and reported for all participants collectively.

RP2D was based on integrated evaluation of safety, tolerability, clinical benefit, pharmacokinetic (PK), and pharmacodynamic data, for all dose levels was tested.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=42 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Recommended Phase 2 Dose (RP2D) of BNT411	4.8 microgram/kilogram (mcg/kg)	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1A: Cycle 1 Day 1; Cycle 2 Day 1; Part 1B: Cycle 1 Day 2; Cycle 2 Day 2 (each cycle duration=21 days)

Population: Analysis was performed on PK evaluable set that included all participants who received at least one dose of BNT411 and have at least one quantifiable post-dose PK sample. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and number analyzed signifies participants with available data at respective visit and "0" in the number analyzed field signifies that no participants were available for analysis at the specified visit.

AUC0-last defined as the AUC from time 0 to the last measurable time-point was calculated from plasma concentrations of BNT411 using the linear-log trapezoidal method.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=7 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
Pharmacokinetics (PK) Assessment for BNT411: Area Under the Concentration Time Curve (AUC0-last) Cycle 1 Day 1	187.3477 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	1477.6656 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	3123.7583 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	4724.5276 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 3433.94480	9445.2536 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 3902.75812	18735.9783 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 11750.72661	22365.2916 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 8763.37410	49384.9308 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 31393.75269	29680.3554 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 12850.18934	—	—
Pharmacokinetics (PK) Assessment for BNT411: Area Under the Concentration Time Curve (AUC0-last) Cycle 2 Day 1	327.1261 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 143.16329	3341.8368 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	2313.8369 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	4635.3150 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 3330.49325	11745.1614 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 2871.09499	20998.2267 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 11223.40206	18392.6594 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 7546.26734	26266.1125 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 18091.16303	28693.3094 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 7377.64393	—	—
Pharmacokinetics (PK) Assessment for BNT411: Area Under the Concentration Time Curve (AUC0-last) Cycle 1 Day 2	—	—	—	—	—	—	—	—	—	3604.2235 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 1804.20847	6258.0743 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 1565.55574
Pharmacokinetics (PK) Assessment for BNT411: Area Under the Concentration Time Curve (AUC0-last) Cycle 2 Day 2	—	—	—	—	—	—	—	—	—	3543.6926 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation 4508.63205	3369.5271 hours (h)*picogram (pg)/milliliters (mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.

SECONDARY outcome

Timeframe: Part 1A: Cycle 1 Day 1; Cycle 2 Day 1; Part 1B: Cycle 1 Day 2; Cycle 2 Day 2 (each cycle duration=21 days)

Population: Analysis was performed on PK evaluable set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and number analyzed signifies participants with available data at respective visit and "0" in the number analyzed field signifies that no participants were available for analysis at the specified visit.

Clearance reflects the elimination of the drug from the body was estimated from plasma concentrations of BNT411 as Dose/AUC0-inf. Dose was converted, as necessary, to reflect the amount of anhydrous BNT411 administered.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=1 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=7 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=5 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=2 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
PK Assessment for BNT411: Clearance (CL) Cycle 1 Day 1	27.6502 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	8.3063 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	13.1362 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	36.6351 liters (L)/hours (h) Standard Deviation 34.63090	21.1677 liters (L)/hours (h) Standard Deviation 8.41500	23.6285 liters (L)/hours (h) Standard Deviation 9.44317	24.7574 liters (L)/hours (h) Standard Deviation 24.89704	13.4479 liters (L)/hours (h) Standard Deviation 6.36326	24.4680 liters (L)/hours (h) Standard Deviation 9.09568	—	—
PK Assessment for BNT411: Clearance (CL) Cycle 2 Day 2	—	—	—	—	—	—	—	—	—	14.3209 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	38.3186 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.
PK Assessment for BNT411: Clearance (CL) Cycle 2 Day 1	—	3.5213 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	17.6849 liters (L)/hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	28.0090 liters (L)/hours (h) Standard Deviation 14.49788	13.9638 liters (L)/hours (h) Standard Deviation 2.28039	22.2684 liters (L)/hours (h) Standard Deviation 13.53332	25.7574 liters (L)/hours (h) Standard Deviation 14.62545	20.8883 liters (L)/hours (h) Standard Deviation 3.90723	21.9203 liters (L)/hours (h) Standard Deviation 10.72759	—	—
PK Assessment for BNT411: Clearance (CL) Cycle 1 Day 2	—	—	—	—	—	—	—	—	—	20.5762 liters (L)/hours (h) Standard Deviation 10.33093	30.8326 liters (L)/hours (h) Standard Deviation 5.92557

SECONDARY outcome

Timeframe: Part 1A: Cycle 1 Day 1; Cycle 2 Day 1; Part 1B: Cycle 1 Day 2; Cycle 2 Day 2 (each cycle duration=21 days)

Volume of distribution (Vd) is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd was estimated from plasma concentrations of BNT411.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=1 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=7 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=5 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=2 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
PK Assessment for BNT411: Volume of Distribution (Vd) Cycle 1 Day 1	75.5414 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	47.0697 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	108.1691 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	296.6890 liters (L) Standard Deviation 313.18628	220.7140 liters (L) Standard Deviation 74.05373	232.0475 liters (L) Standard Deviation 100.19550	168.7668 liters (L) Standard Deviation 145.45978	156.7781 liters (L) Standard Deviation 77.21878	222.3040 liters (L) Standard Deviation 85.88236	—	—
PK Assessment for BNT411: Volume of Distribution (Vd) Cycle 2 Day 1	—	18.6963 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	159.4620 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	194.0698 liters (L) Standard Deviation 97.37669	127.2646 liters (L) Standard Deviation 21.21154	187.7812 liters (L) Standard Deviation 96.09022	163.0226 liters (L) Standard Deviation 44.35908	186.4341 liters (L) Standard Deviation 31.41644	148.4863 liters (L) Standard Deviation 125.70109	—	—
PK Assessment for BNT411: Volume of Distribution (Vd) Cycle 1 Day 2	—	—	—	—	—	—	—	—	—	132.8456 liters (L) Standard Deviation 22.90794	205.7365 liters (L) Standard Deviation 14.86844
PK Assessment for BNT411: Volume of Distribution (Vd) Cycle 2 Day 2	—	—	—	—	—	—	—	—	—	125.7815 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	243.8492 liters (L) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.

SECONDARY outcome

Timeframe: Part 1A: Cycle 1 Day 1; Cycle 2 Day 1; Part 1B: Cycle 1 Day 2; Cycle 2 Day 2 (each cycle duration=21 days)

Population: Analysis was performed on the PK evaluable set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and number analyzed signifies participants with available data at respective visit and "0" in the number analyzed field signifies that no participants were available for analysis at the specified visit.

Cmax defined as the maximum observed plasma concentration was estimated from plasma concentrations of BNT411.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=7 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
PK Assessment for BNT411: Maximum Plasma Concentration (Cmax) Cycle 1 Day 1	152.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	1020.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	2437.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	3229.3 picogram/milliliters (pg/mL) Standard Deviation 1847.84	8191.3 picogram/milliliters (pg/mL) Standard Deviation 3211.56	13005.9 picogram/milliliters (pg/mL) Standard Deviation 4681.33	20404.6 picogram/milliliters (pg/mL) Standard Deviation 8137.20	31596.8 picogram/milliliters (pg/mL) Standard Deviation 10260.05	25967.7 picogram/milliliters (pg/mL) Standard Deviation 10270.43	—	—
PK Assessment for BNT411: Maximum Plasma Concentration (Cmax) Cycle 2 Day 1	254.0 picogram/milliliters (pg/mL) Standard Deviation 57.98	2163.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	1520.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	2947.3 picogram/milliliters (pg/mL) Standard Deviation 1281.14	8104.7 picogram/milliliters (pg/mL) Standard Deviation 1473.43	14804.4 picogram/milliliters (pg/mL) Standard Deviation 6042.78	13800.0 picogram/milliliters (pg/mL) Standard Deviation 3642.80	19551.8 picogram/milliliters (pg/mL) Standard Deviation 16904.30	22547.8 picogram/milliliters (pg/mL) Standard Deviation 7933.89	—	—
PK Assessment for BNT411: Maximum Plasma Concentration (Cmax) Cycle 1 Day 2	—	—	—	—	—	—	—	—	—	2880.33 picogram/milliliters (pg/mL) Standard Deviation 2065.462	5598.25 picogram/milliliters (pg/mL) Standard Deviation 766.713
PK Assessment for BNT411: Maximum Plasma Concentration (Cmax) Cycle 2 Day 2	—	—	—	—	—	—	—	—	—	2993.95 picogram/milliliters (pg/mL) Standard Deviation 4214.427	2900.00 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.

SECONDARY outcome

Timeframe: Part 1A: Cycle 1 Day 1; Cycle 2 Day 1; Part 1B: Cycle 1 Day 2; Cycle 2 Day 2 (each cycle duration=21 days)

Tmax defined as the time to reach maximum (peak) concentration was estimated from plasma concentrations of BNT411.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=7 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
PK Assessment for BNT411: Time to Reach Cmax (Tmax) Cycle 1 Day 1	0.7667 hours (h) Full range could not be calculated as only 1 participant was available for the analysis.	0.5000 hours (h) Interval 0.5 to 0.5	0.5667 hours (h) Full range could not be calculated as only 1 participant was available for the analysis.	0.6500 hours (h) Interval 0.533 to 0.683	0.5417 hours (h) Interval 0.5 to 0.6	0.5917 hours (h) Interval 0.5 to 0.867	0.6000 hours (h) Interval 0.55 to 0.7	0.5417 hours (h) Interval 0.5 to 0.717	0.6000 hours (h) Interval 0.5 to 0.667	—	—
PK Assessment for BNT411: Time to Reach Cmax (Tmax) Cycle 2 Day 1	0.5750 hours (h) Interval 0.567 to 0.583	0.5000 hours (h) Interval 0.5 to 0.5	0.5833 hours (h) Full range could not be calculated as only 1 participant was available for the analysis.	0.5833 hours (h) Interval 0.583 to 0.7	0.5000 hours (h) Interval 0.5 to 0.583	0.6000 hours (h) Interval 0.5 to 0.817	0.6167 hours (h) Interval 0.583 to 0.617	0.6333 hours (h) Interval 0.567 to 0.667	0.6417 hours (h) Interval 0.6 to 0.75	—	—
PK Assessment for BNT411: Time to Reach Cmax (Tmax) Cycle 1 Day 2	—	—	—	—	—	—	—	—	—	0.5833 hours (h) Interval 0.5 to 1.017	0.6000 hours (h) Interval 0.5 to 0.85
PK Assessment for BNT411: Time to Reach Cmax (Tmax) Cycle 2 Day 2	—	—	—	—	—	—	—	—	—	13.1083 hours (h) Interval 0.633 to 25.583	0.5833 hours (h) Full range could not be calculated as only 1 participant was available for the analysis.

SECONDARY outcome

Timeframe: Part 1A: Start of infusion on Cycle 1 Day 8, Day 15, Day 22, Day 43; Day 85; Part 1B: Start of infusion on Cycle 1 Day 8, Day 15, Day 23, Day 44 (each cycle duration=21 days)

Ctrough defined as the pre-dose concentrations of BNT411 was estimated from the plasma concentrations of BNT411.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=2 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=8 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=6 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=2 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=4 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=2 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 22	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	—	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	51.500 picogram/milliliters (pg/mL) Standard Deviation 72.8320	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	1.770 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	—	—
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 8	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.476 picogram/milliliters (pg/mL) Standard Deviation 0.9789	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.0 picogram/milliliters (pg/mL) Standard Deviation 0.00	0.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 15	8.400 picogram/milliliters (pg/mL) Standard Deviation 11.8794	—	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.000 picogram/milliliters (pg/mL) Standard Deviation 0.0000	0.253 picogram/milliliters (pg/mL) Standard Deviation 0.5050	0.168 picogram/milliliters (pg/mL) Standard Deviation 0.4123	0.580 picogram/milliliters (pg/mL) Standard Deviation 0.6722	1.350 picogram/milliliters (pg/mL) Standard Deviation 0.2970	1.655 picogram/milliliters (pg/mL) Standard Deviation 0.5303	0.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.0 picogram/milliliters (pg/mL) Standard Deviation 0.00
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 23	—	—	—	—	—	—	—	—	—	—	0.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 43	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	—	—	4.833 picogram/milliliters (pg/mL) Standard Deviation 8.3716	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.370 picogram/milliliters (pg/mL) Standard Deviation 0.6409	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.970 picogram/milliliters (pg/mL) Standard Deviation 1.3718	1.690 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	—	—
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 44	—	—	—	—	—	—	—	—	—	0.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.0 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.
PK Assessment for BNT411: Trough Concentration (Ctrough) Cycle 1 Day 85	—	—	—	0.590 picogram/milliliters (pg/mL) Standard Deviation 0.8344	—	—	38500.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	1.170 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	0.000 picogram/milliliters (pg/mL) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	—	—

SECONDARY outcome

Timeframe: Part 1A: Cycle 1 Day 1; Cycle 2 Day 1; Part 1B: Cycle 1 Day 2; Cycle 2 Day 2 (each cycle duration=21 days)

Terminal elimination half-life was estimated from the plasma concentrations of BNT411.

Outcome measures

Outcome measures
Measure	Part 1A: BNT411 Monotherapy: DL1: 0.05 mcg/kg n=1 Participants Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 Participants Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 Participants Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=7 Participants Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=5 Participants Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 Participants Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=2 Participants Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 Participants Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.
PK Assessment for BNT411: Terminal Elimination Half-life (T1/2) Cycle 2 Day 1	—	3.6803 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	6.2500 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	4.9020 hours (h) Standard Deviation 0.57744	6.3386 hours (h) Standard Deviation 0.73577	6.0603 hours (h) Standard Deviation 1.18916	4.9479 hours (h) Standard Deviation 1.51079	6.2166 hours (h) Standard Deviation 0.45957	4.5667 hours (h) Standard Deviation 2.07892	—	—
PK Assessment for BNT411: Terminal Elimination Half-life (T1/2) Cycle 1 Day 1	1.8937 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	3.9279 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	5.7077 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	5.2525 hours (h) Standard Deviation 0.99582	7.4679 hours (h) Standard Deviation 1.87347	7.4600 hours (h) Standard Deviation 4.30673	5.1189 hours (h) Standard Deviation 1.23014	8.7346 hours (h) Standard Deviation 4.71577	6.2721 hours (h) Standard Deviation 0.48131	—	—
PK Assessment for BNT411: Terminal Elimination Half-life (T1/2) Cycle 1 Day 2	—	—	—	—	—	—	—	—	—	4.8989 hours (h) Standard Deviation 1.68795	4.7244 hours (h) Standard Deviation 0.68988
PK Assessment for BNT411: Terminal Elimination Half-life (T1/2) Cycle 2 Day 2	—	—	—	—	—	—	—	—	—	6.0880 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.	4.4110 hours (h) Standard Deviation NA Standard deviation could not be calculated as only 1 participant was available for the analysis.

Adverse Events

Part 1A: BNT411 Monotherapy: Dose Level (DL) 1: 0.05 mcg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg

Serious events: 5 serious events

Other events: 14 other events

Deaths: 11 deaths

Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 4 deaths

Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Part 1A: BNT411 Monotherapy: Dose Level (DL) 1: 0.05 mcg/kg n=2 participants at risk Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 participants at risk Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 participants at risk Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 participants at risk Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 participants at risk Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 participants at risk Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=8 participants at risk Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 participants at risk Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 participants at risk Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 participants at risk Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 participants at risk Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Diplopia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Nausea	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Oesophagitis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Asthenia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Disease progression	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Fatigue	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Pain	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Pyrexia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Hepatobiliary disorders Hepatic failure	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Immune system disorders Cytokine release syndrome	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations COVID-19	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Device related infection	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Pneumonia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Respiratory tract infection	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Sepsis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Platelet count decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour thrombosis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Cerebrovascular accident	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Dysarthria	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Mental status changes	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Vascular disorders Superior vena cava syndrome	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).

Other adverse events

Other adverse events
Measure	Part 1A: BNT411 Monotherapy: Dose Level (DL) 1: 0.05 mcg/kg n=2 participants at risk Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg n=1 participants at risk Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg n=1 participants at risk Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg n=3 participants at risk Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg n=4 participants at risk Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg n=14 participants at risk Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg n=8 participants at risk Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg n=6 participants at risk Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg n=6 participants at risk Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg n=3 participants at risk Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg n=4 participants at risk Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Cardiac disorders Atrioventricular block first degree	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	75.0% 3/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Cardiac disorders Myopericarditis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Cardiac disorders Sinus bradycardia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Cardiac disorders Sinus tachycardia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Cardiac disorders Tachycardia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Ear and labyrinth disorders Ear pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Blepharitis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Cataract	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Dry eye	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Eye irritation	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Eye pruritus	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Meibomian gland dysfunction	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Retinal exudates	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Retinal haemorrhage	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Vision blurred	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Visual field defect	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Visual impairment	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Eye disorders Vitreous detachment	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Abdominal pain lower	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Abdominal pain upper	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Ascites	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Constipation	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	35.7% 5/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	21.4% 3/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 2/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Dry mouth	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Dysphagia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Flatulence	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Haematemesis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Lip dry	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Nausea	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	57.1% 8/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	37.5% 3/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	83.3% 5/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Stomatitis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Gastrointestinal disorders Vomiting	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	21.4% 3/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 2/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	83.3% 5/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Asthenia	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Axillary pain	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Chills	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 2/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 4/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Energy increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Face oedema	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Fatigue	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 2/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	42.9% 6/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	37.5% 3/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	83.3% 5/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Gait disturbance	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders General physical health deterioration	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Generalised oedema	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Influenza like illness	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Malaise	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Mucosal inflammation	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Non-cardiac chest pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Oedema peripheral	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
General disorders Pyrexia	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	35.7% 5/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	37.5% 3/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Hepatobiliary disorders Hepatic pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Immune system disorders Cytokine release syndrome	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	21.4% 3/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	62.5% 5/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 4/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Immune system disorders Drug hypersensitivity	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Bacteraemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations COVID-19	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Cystitis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Herpes simplex reactivation	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Lower respiratory tract infection	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Nasopharyngitis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Oesophageal candidiasis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Oral candidiasis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Oral herpes	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Pneumonia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Infections and infestations Urinary tract infection	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Injury, poisoning and procedural complications Fall	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	21.4% 3/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Injury, poisoning and procedural complications Joint injury	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Activated partial thromboplastin time prolonged	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Alanine aminotransferase increased	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Amylase increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Aspartate aminotransferase increased	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	37.5% 3/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Bacterial test positive	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood bilirubin increased	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood calcium decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood creatinine increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 2/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood fibrinogen decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood potassium decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood potassium increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Blood thyroid stimulating hormone increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations C-reactive protein increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations International normalised ratio increased	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Liver function test increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Lymphocyte count decreased	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Neutrophil count decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Platelet count decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 2/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Respiratory rate increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Troponin I increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 2/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Weight decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations Weight increased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations White blood cell count decreased	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Investigations White blood cells urine positive	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Decreased appetite	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 2/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Muscle spasms	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Vascular disorders Hypertension	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Brain fog	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Dizziness	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Dysgeusia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Headache	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	21.4% 3/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 2/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	50.0% 3/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Hemiparesis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Lethargy	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Neurotoxicity	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Paraesthesia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Nervous system disorders Tremor	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Agitation	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Anxiety	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Confusional state	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Delirium	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Depression	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Insomnia	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Sleep disorder	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Psychiatric disorders Social avoidant behaviour	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Chromaturia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Dysuria	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Haematuria	50.0% 1/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Micturition urgency	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Nocturia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Oliguria	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Pollakiuria	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Proteinuria	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Urinary incontinence	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	14.3% 2/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	66.7% 2/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	12.5% 1/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 1/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	33.3% 2/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Vascular disorders Deep vein thrombosis	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Vascular disorders Embolism	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	7.1% 1/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Vascular disorders Flushing	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	25.0% 1/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).
Vascular disorders Hypotension	0.00% 0/2 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	100.0% 1/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/1 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	21.4% 3/14 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/8 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	16.7% 1/6 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/3 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).	0.00% 0/4 • From Baseline until 60 days after the last dose of study treatment (3 years and 11 months) All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).

Additional Information

BioNTech clinical trials patient information

BioNTech SE

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigators respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
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Restriction type: OTHER