Trial Outcomes & Findings for A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older (NCT NCT04652102)

Last Updated: 2024-04-29

Results Overview

A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). * Primary efficacy cases were confirmed by an Adjudication Committee. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

39680 participants

Primary outcome timeframe

Day 44 to Day 393

Results posted on

2024-04-29

Participant Flow

This trial was performed in Argentina, Belgium, Colombia, the Dominican Republic, Germany, Mexico, the Netherlands, Panama, Peru and Spain between 11 December 2020 and 10 June 2022.

Of the 39680 participants who were randomized, 39540 participants received at least one dose vaccine.

Participant milestones

Participant milestones
Measure	CVnCoV 12 μg Vaccine Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Overall Study STARTED	19787	19753
Overall Study Phase 2b Participants	2007	1987
Overall Study Phase 3 Participants	17780	17766
Overall Study Rolled Over to Open-Label Phase	8513	0
Overall Study COMPLETED	11451	4161
Overall Study NOT COMPLETED	8336	15592

Reasons for withdrawal

Reasons for withdrawal
Measure	CVnCoV 12 μg Vaccine Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Overall Study Adverse Event	14	13
Overall Study Subject Received Alternative Authorised Vaccine	1407	6552
Overall Study Physician Decision	78	40
Overall Study Study Ended by Sponsor	64	17
Overall Study Withdrawal by Subject	4625	5594
Overall Study Lost to Follow-up	2019	1082
Overall Study Protocol Specified Withdrawal Criterion Met	49	2230
Overall Study Miscellaneous	80	64

Baseline Characteristics

A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CVnCoV 12 μg Vaccine n=19787 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Total n=39540 Participants Total of all reporting groups
Age, Continuous	43.0 years STANDARD_DEVIATION 14.49 • n=5 Participants	43.0 years STANDARD_DEVIATION 14.50 • n=7 Participants	43.0 years STANDARD_DEVIATION 14.50 • n=5 Participants
Sex: Female, Male Female	8935 Participants n=5 Participants	8936 Participants n=7 Participants	17871 Participants n=5 Participants
Sex: Female, Male Male	10852 Participants n=5 Participants	10817 Participants n=7 Participants	21669 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14732 Participants n=5 Participants	14740 Participants n=7 Participants	29472 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4960 Participants n=5 Participants	4932 Participants n=7 Participants	9892 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	95 Participants n=5 Participants	81 Participants n=7 Participants	176 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	9012 Participants n=5 Participants	8989 Participants n=7 Participants	18001 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	383 Participants n=5 Participants	356 Participants n=7 Participants	739 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian Indian	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race · Chinese	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race · Filipino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Japanese	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Korean	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Vietnamese	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2492 Participants n=5 Participants	2485 Participants n=7 Participants	4977 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	7797 Participants n=5 Participants	7812 Participants n=7 Participants	15609 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	34 Participants n=5 Participants	44 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 44 to Day 393

Population: Efficacy Analysis Set (EAS): All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination \& were SARS-CoV-2 naïve at baseline \& Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or been unblinded prior to 15 days after the second vaccination.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=12851 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=12211 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity	83 Participants	145 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 211

Population: Safety Analysis Set (SAS): Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo.

Medically-attended AEs were defined as AEs with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=19787 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) Any Medically-attended AE	2555 Participants	2084 Participants
Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) Any Related Medically-attended AE	505 Participants	138 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 393

Population: SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo.

An SAE was defined as 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 in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and occurrence of each SAE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=19787 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced One or More Serious AE (SAE) Any SAE	149 Participants	111 Participants
Number of Participants Who Experienced One or More Serious AE (SAE) Any Related SAE	8 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 393

Population: SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. Only participants who experienced SAEs were included.

An SAE was defined as 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 in the offspring of the participant. * Was an important medical event. The Investigator made an assessment of intensity of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=149 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=111 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Intensity of SAEs as Per Investigator Assessment Mild (Grade 1)	21 Participants	10 Participants
Intensity of SAEs as Per Investigator Assessment Moderate (Grade 2)	50 Participants	35 Participants
Intensity of SAEs as Per Investigator Assessment Severe (Grade 3)	74 Participants	66 Participants
Intensity of SAEs as Per Investigator Assessment Missing	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 393

Population: SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo.

AESIs included: * AEs with a suspected immune-medicated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. The Investigator assessed the relationship between trial vaccine and occurrence of each AESI. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=19787 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI) Any AESI	64 Participants	47 Participants
Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI) Any Related AESI	19 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 393

Population: SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo.

A fatal SAE was defined as an SAE that resulted in death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=19787 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced a Fatal SAE	11 Participants	12 Participants

PRIMARY outcome

Timeframe: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)

Population: The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=2003 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=1978 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE Any Solicited Local AE	1699 Participants	477 Participants
Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE Any Solicited Systemic AE	1881 Participants	1255 Participants

PRIMARY outcome

Timeframe: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)

Population: The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. Only participants who experienced solicited AEs were included.

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=1933 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=1344 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment Any Solicited Local AEs · Mild (Grade 1)	1226 Participants	452 Participants
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment Any Solicited Local AEs · Moderate (Grade 2)	448 Participants	24 Participants
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment Any Solicited Local AEs · Severe (Grade 3)	25 Participants	1 Participants
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment Any Solicited Systemic AEs · Mild (Grade 1)	376 Participants	708 Participants
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment Any Solicited Systemic AEs · Moderate (Grade 2)	969 Participants	487 Participants
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment Any Solicited Systemic AEs · Severe (Grade 3)	536 Participants	60 Participants

PRIMARY outcome

Timeframe: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=1933 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=1344 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Phase 2b Participants Only: Duration of Solicited AEs Solicited Local AEs - Injection Site Pain	2.3 days Standard Deviation 1.24	1.5 days Standard Deviation 1.24
Phase 2b Participants Only: Duration of Solicited AEs Solicited Local AEs - Redness	2.2 days Standard Deviation 2.32	2.1 days Standard Deviation 1.99
Phase 2b Participants Only: Duration of Solicited AEs Solicited Local AEs - Swelling	1.7 days Standard Deviation 0.97	1.2 days Standard Deviation 0.56
Phase 2b Participants Only: Duration of Solicited AEs Solicited Local AEs - Itching	1.6 days Standard Deviation 1.20	1.4 days Standard Deviation 1.42
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Fever	1.3 days Standard Deviation 0.52	1.0 days Standard Deviation 0.00
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Headache	2.0 days Standard Deviation 1.41	1.8 days Standard Deviation 2.45
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Fatigue	2.3 days Standard Deviation 2.84	2.0 days Standard Deviation 2.25
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Chills	1.3 days Standard Deviation 0.67	1.4 days Standard Deviation 0.83
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Myalgia	1.8 days Standard Deviation 1.08	1.6 days Standard Deviation 1.13
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Arthralgia	1.6 days Standard Deviation 0.98	1.6 days Standard Deviation 1.19
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Nausea/Vomiting	1.5 days Standard Deviation 0.97	1.3 days Standard Deviation 0.82
Phase 2b Participants Only: Duration of Solicited AEs Solicited Systemic AEs - Diarrhea	1.4 days Standard Deviation 0.95	1.3 days Standard Deviation 0.90

PRIMARY outcome

Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)

Population: SAS 2: Included all Phase 2b participants of the SAS.

eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=2007 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=1987 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE Any Unsolicited AE	1016 Participants	911 Participants
Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE Any Related Unsolicited AE	511 Participants	269 Participants

PRIMARY outcome

Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)

Population: SAS 2: Included all Phase 2b participants of the SAS.

eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=1016 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=911 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment Mild (Grade 1)	712 Participants	641 Participants
Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment Moderate (Grade 2)	259 Participants	225 Participants
Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment Severe (Grade 3)	44 Participants	38 Participants
Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment Missing	1 Participants	7 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 393

Population: SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo.

Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=19787 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation Any AE Leading to Withdrawal From Trial	17 Participants	16 Participants
Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation Any AE Leading to Vaccine Withdrawal	32 Participants	33 Participants

SECONDARY outcome

Timeframe: Day 44 to Day 393

Population: EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, \& were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination.

Moderate cases defined by any 1 of the following: * Shortness of breath/difficulty breathing * Respiratory rate ≥20 to \<30 breaths per min * Abnormal SpO2 but still \>93% on room air at sea level * Clinical/radiographic evidence of lower respiratory tract disease * Radiologic evidence of DVT Severe cases defined by any 1 of the following: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30breaths per minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 \<300 mm Hg) * Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO) * Evidence of shock (SBP \<90mm Hg, DBP \<60 mmHg or requiring vasopressors) * Significant renal, hepatic, or neurologic dysfunction * Admission to ICU * Death Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=12851 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=12211 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19	12 Participants	37 Participants

SECONDARY outcome

Timeframe: Day 44 to Day 393

Severe COVID-19 cases were defined by any one of the following: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 \< 300 mm Hg). * Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO). * Evidence of shock (SBP \< 90mm Hg, DBP \< 60 mmHg, or requiring vasopressors). * Significant renal, hepatic, or neurologic dysfunction * Admission to intensive care unit (ICU). * Death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=12851 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=12211 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19	4 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 44 to Day 393

The characterization of SARS-CoV-2 variants were implemented by viral whole genome sequencing of nasopharyngeal swab samples of participants followed by comparison with previously sequenced and typified genomes. The following phylogenetic clustering was applied: 1. "Wild type" virus: WT/D614G, lineages A.1/B.1 without the variant of concerns (VOCs) (i.e., without B.1.1.7 \[Alpha\], B.1.351 \[Beta\], B.1.429 \[Epsilon\]). 2. "UK" VOC: B.1.1.7 (Alpha). A case of COVID-19 was defined as follows: * Virologically-confirmed case of COVID-19 defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second vaccination. * First episode of virologically-confirmed COVID-19. * Participant was SARS-CoV-2 naïve at baseline and Day 43. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=12851 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=12211 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With "Wild Type" and "Alpha" SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants	29 Participants	56 Participants

SECONDARY outcome

Timeframe: Day 44 to Day 393

Population: The EAS including only participants who were aged ≥ 61.

A case of COVID-19 was defined as follows: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=1319 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=1180 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity	12 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 44 to Day 393

Score #1 was defined as no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=12851 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=12211 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 2	4 Participants	10 Participants
Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 0	12768 Participants	12066 Participants
Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 1	79 Participants	135 Participants

SECONDARY outcome

Timeframe: Day 44 to Day 393

Score #2 was defined as no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=12851 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=12211 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 3	1 Participants	0 Participants
BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 0	12768 Participants	12066 Participants
BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 1	82 Participants	143 Participants
BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 2	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Days 1 (baseline), 29, 43, 120 and 211

Population: Per Protocol Immunogenicity (PPI) Set: Included all Phase 2b participants from the Immunogenicity Subset who received both doses as randomized and within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis.

Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme- linked immunosorbent assay (ELISA) and expressed as geometric mean of titers (GMT) with 95% confidence interval (CI), by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=544 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=525 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 Day 1	50.791 titers Interval 50.151 to 51.439	50.763 titers Interval 50.079 to 51.456
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 Day 29	54.090 titers Interval 52.213 to 56.034	50.734 titers Interval 50.074 to 51.403
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 Day 43	734.657 titers Interval 645.552 to 836.061	50.902 titers Interval 50.082 to 51.737
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 Day 120	227.439 titers Interval 203.647 to 254.011	57.357 titers Interval 52.843 to 62.257
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 Day 211	371.341 titers Interval 161.098 to 855.966	107.556 titers Interval 23.919 to 483.648

SECONDARY outcome

Timeframe: Baseline and Days 29, 43, 120 and 211

Population: PPI Set: Included all Phase 2b participants seronegative at baseline from the Immunogenicity Subset who received both doses as randomized \& within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis.

Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 RBD of S protein. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=536 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=516 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 Day 120	72.2 percentage of participants Interval 67.7 to 76.4	4.9 percentage of participants Interval 2.6 to 8.4
Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 Day 211	66.7 percentage of participants Interval 46.0 to 83.5	28.6 percentage of participants Interval 3.7 to 71.0
Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 Day 29	4.3 percentage of participants Interval 2.7 to 6.4	0.4 percentage of participants Interval 0.0 to 1.4
Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 Day 43	87.1 percentage of participants Interval 83.9 to 89.8	0.6 percentage of participants Interval 0.1 to 1.8

SECONDARY outcome

Timeframe: Days 1 (baseline), 29, 43, 120 and 211

Population: PPI Set: Included all Phase 2b participants from the Immunogenicity Subset who received both doses as randomized and within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis.

Titers of viral neutralizing antibodies were determined by an activity assay and expressed as GMT with 95% CI, by group. Individual values below the LLOQ were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=544 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=525 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 Day 1 (Baseline)	5.016 titers Interval 4.993 to 5.039	5.007 titers Interval 4.994 to 5.02
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 Day 43	18.211 titers Interval 16.394 to 20.23	5.049 titers Interval 5.003 to 5.096
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 Day 120	7.105 titers Interval 6.64 to 7.603	5.136 titers Interval 5.008 to 5.267
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 Day 29	5.141 titers Interval 5.022 to 5.263	5.030 titers Interval 4.995 to 5.066
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 Day 211	14.325 titers Interval 7.183 to 28.565	6.729 titers Interval 4.209 to 10.757

SECONDARY outcome

Timeframe: Baseline and Days 29, 43, 120 and 211

Titers of viral neutralizing antibodies were determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 neutralizing antibody titer. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 12 μg Vaccine n=536 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=516 Participants Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211 Day 120	24.8 percentage of participants Interval 20.8 to 29.1	2.0 percentage of participants Interval 0.7 to 4.7
Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211 Day 29	1.5 percentage of participants Interval 0.6 to 2.9	0.6 percentage of participants Interval 0.1 to 1.7
Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211 Day 43	65.1 percentage of participants Interval 60.8 to 69.2	1.0 percentage of participants Interval 0.3 to 2.3
Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211 Day 211	33.3 percentage of participants Interval 16.5 to 54.0	28.6 percentage of participants Interval 3.7 to 71.0

Adverse Events

CVnCoV 12 μg Vaccine

Serious events: 149 serious events

Other events: 3144 other events

Deaths: 17 deaths

Placebo

Serious events: 111 serious events

Other events: 1853 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CVnCoV 12 μg Vaccine n=19787 participants at risk Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.	Placebo n=19753 participants at risk Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
General disorders Chills	7.3% 1439/19787 • Number of events 2065 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.	1.2% 240/19753 • Number of events 286 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.
General disorders Fatigue	9.6% 1893/19787 • Number of events 3200 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.	5.2% 1019/19753 • Number of events 1483 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.
General disorders Injection site pain	10.1% 2008/19787 • Number of events 3231 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.	2.7% 537/19753 • Number of events 644 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.
General disorders Pyrexia	6.6% 1305/19787 • Number of events 1700 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.	0.48% 95/19753 • Number of events 102 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 1728/19787 • Number of events 2588 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.	2.6% 509/19753 • Number of events 634 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.
Nervous system disorders Headache	11.7% 2310/19787 • Number of events 3911 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.	6.2% 1225/19753 • Number of events 1805 • Day 1 to Day 393 Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.

Additional Information

Clinical Trial Information

CureVac AG

Phone: 0049 6976805870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place