Trial Outcomes & Findings for The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection (NCT NCT06065176)

Last Updated: 2026-01-28

Results Overview

Difference in the number of symptomatic SARS-CoV-2 infections between randomized, study-vaccinated participants and the comparator group who did not receive an updated COVID-19 vaccine (2023-2024 formula).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1188 participants

Primary outcome timeframe

24 weeks after enrollment

Results posted on

2026-01-28

Participant Flow

The BEEHIVE trial enrolled and monitored participants from 22 November 2023 through 9 September 2024. 5590 participants were screened.

1188 total participants enrolled.

Participant milestones

Participant milestones
Measure	Novavax COVID-19 Booster 452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Pfizer COVID-19 Booster 457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Non-boosted Comparison Group 279 participants did not receive a dose of the study vaccine.
Overall Study STARTED	452	457	279
Overall Study COMPLETED	437	440	266
Overall Study NOT COMPLETED	15	17	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Novavax COVID-19 Booster 452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Pfizer COVID-19 Booster 457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Non-boosted Comparison Group 279 participants did not receive a dose of the study vaccine.
Overall Study Lost to Follow-up	11	11	10
Overall Study Withdrawal by Subject	1	1	2
Overall Study No longer met eligibility requirements to continue participation.	3	5	1

Baseline Characteristics

The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novavax COVID-19 Booster n=452 Participants 452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Pfizer COVID-19 Booster n=457 Participants 457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Non-boosted Comparison Group n=279 Participants 279 participants did not receive a dose of the study vaccine.	Total n=1188 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=158 Participants	5 Participants n=157 Participants	2 Participants n=315 Participants	10 Participants n=153 Participants
Age, Categorical Between 18 and 65 years	409 Participants n=158 Participants	406 Participants n=157 Participants	246 Participants n=315 Participants	1061 Participants n=153 Participants
Age, Categorical >=65 years	40 Participants n=158 Participants	46 Participants n=157 Participants	31 Participants n=315 Participants	117 Participants n=153 Participants
Sex/Gender, Customized Sex Assigned at Birth · Female	248 Participants n=158 Participants	250 Participants n=157 Participants	147 Participants n=315 Participants	645 Participants n=153 Participants
Sex/Gender, Customized Sex Assigned at Birth · Male	203 Participants n=158 Participants	206 Participants n=157 Participants	132 Participants n=315 Participants	541 Participants n=153 Participants
Sex/Gender, Customized Sex Assigned at Birth · Prefer Not to Answer	1 Participants n=158 Participants	1 Participants n=157 Participants	0 Participants n=315 Participants	2 Participants n=153 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=158 Participants	5 Participants n=157 Participants	1 Participants n=315 Participants	7 Participants n=153 Participants
Race (NIH/OMB) Asian	13 Participants n=158 Participants	23 Participants n=157 Participants	15 Participants n=315 Participants	51 Participants n=153 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=158 Participants	1 Participants n=157 Participants	0 Participants n=315 Participants	1 Participants n=153 Participants
Race (NIH/OMB) Black or African American	7 Participants n=158 Participants	5 Participants n=157 Participants	1 Participants n=315 Participants	13 Participants n=153 Participants
Race (NIH/OMB) White	393 Participants n=158 Participants	394 Participants n=157 Participants	241 Participants n=315 Participants	1028 Participants n=153 Participants
Race (NIH/OMB) More than one race	34 Participants n=158 Participants	25 Participants n=157 Participants	16 Participants n=315 Participants	75 Participants n=153 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=158 Participants	4 Participants n=157 Participants	5 Participants n=315 Participants	13 Participants n=153 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=158 Participants	49 Participants n=157 Participants	25 Participants n=315 Participants	128 Participants n=153 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	398 Participants n=158 Participants	408 Participants n=157 Participants	254 Participants n=315 Participants	1060 Participants n=153 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants

PRIMARY outcome

Timeframe: 24 weeks after enrollment

Population: mITT population. Combining both vaccinated arms in a single group most appropriately represents the study's primary objective. The two vaccinated arms are assessed relative to each other in the study's secondary objective.

Outcome measures

Outcome measures
Measure	Non-Booster Comparator Group n=278 Participants 279 participants who consented to enrollment but declined receipt of a study vaccine dose.	Randomized Group n=898 Participants 909 were randomized into the protein subunit (N=452) and mRNA (N=457) groups. Randomized participants received a single intramuscular dose of either study vaccine (0.3 mL for mRNA and 0.5 mL for protein subunit) in the deltoid.
Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group	48 Participants	94 Participants

SECONDARY outcome

Timeframe: 24 weeks after study enrollment

Population: mITT population

Difference in the number of symptomatic SARS-CoV-2 infections between the protein subunit and mRNA vaccine groups.

Outcome measures

Outcome measures
Measure	Non-Booster Comparator Group n=444 Participants 279 participants who consented to enrollment but declined receipt of a study vaccine dose.	Randomized Group n=454 Participants 909 were randomized into the protein subunit (N=452) and mRNA (N=457) groups. Randomized participants received a single intramuscular dose of either study vaccine (0.3 mL for mRNA and 0.5 mL for protein subunit) in the deltoid.
Number of Symptomatic SARS-CoV-2 Infections Between the Protein Subunit and mRNA Vaccine Groups.	52 Participants	42 Participants

Adverse Events

Novavax COVID-19 Booster

Serious events: 1 serious events

Other events: 401 other events

Deaths: 0 deaths

Pfizer COVID-19 Booster

Serious events: 5 serious events

Other events: 436 other events

Deaths: 0 deaths

Non-boosted Comparison Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Novavax COVID-19 Booster n=452 participants at risk 452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Pfizer COVID-19 Booster n=457 participants at risk 457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Non-boosted Comparison Group n=279 participants at risk 279 participants did not receive a dose of the study vaccine.
Infections and infestations Infections due to complications of surgery	0.00% 0/452 • From enrollment until the end of follow-up, up to 24 weeks	0.44% 2/457 • Number of events 3 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Musculoskeletal and connective tissue disorders Serious injuries due to auto accident	0.00% 0/452 • From enrollment until the end of follow-up, up to 24 weeks	0.22% 1/457 • Number of events 1 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Psychiatric disorders Hospitalization due to mental health crisis	0.00% 0/452 • From enrollment until the end of follow-up, up to 24 weeks	0.22% 1/457 • Number of events 3 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Pregnancy, puerperium and perinatal conditions Emergency Cesarean Section due to premature labor	0.22% 1/452 • Number of events 1 • From enrollment until the end of follow-up, up to 24 weeks	0.22% 1/457 • Number of events 1 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks

Other adverse events

Other adverse events
Measure	Novavax COVID-19 Booster n=452 participants at risk 452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Pfizer COVID-19 Booster n=457 participants at risk 457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.	Non-boosted Comparison Group n=279 participants at risk 279 participants did not receive a dose of the study vaccine.
Musculoskeletal and connective tissue disorders Injection Site Pain	61.3% 277/452 • Number of events 277 • From enrollment until the end of follow-up, up to 24 weeks	83.6% 382/457 • Number of events 382 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Musculoskeletal and connective tissue disorders Injection Site Swelling	11.3% 51/452 • Number of events 51 • From enrollment until the end of follow-up, up to 24 weeks	24.7% 113/457 • Number of events 113 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Musculoskeletal and connective tissue disorders Injection Site Tenderness	74.6% 337/452 • Number of events 337 • From enrollment until the end of follow-up, up to 24 weeks	88.6% 405/457 • Number of events 405 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Musculoskeletal and connective tissue disorders Muscle Pain	32.3% 146/452 • Number of events 146 • From enrollment until the end of follow-up, up to 24 weeks	52.5% 240/457 • Number of events 240 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Immune system disorders Fatigue	38.7% 175/452 • Number of events 175 • From enrollment until the end of follow-up, up to 24 weeks	54.9% 251/457 • Number of events 251 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Immune system disorders Fever	2.9% 13/452 • Number of events 13 • From enrollment until the end of follow-up, up to 24 weeks	8.8% 40/457 • Number of events 40 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Immune system disorders Joint Pain	10.6% 48/452 • Number of events 48 • From enrollment until the end of follow-up, up to 24 weeks	20.8% 95/457 • Number of events 95 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Immune system disorders Malaise	18.6% 84/452 • Number of events 84 • From enrollment until the end of follow-up, up to 24 weeks	38.7% 177/457 • Number of events 177 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Immune system disorders Nausea	5.8% 26/452 • Number of events 35 • From enrollment until the end of follow-up, up to 24 weeks	9.2% 42/457 • Number of events 55 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks
Immune system disorders Headache	26.8% 121/452 • Number of events 121 • From enrollment until the end of follow-up, up to 24 weeks	36.8% 168/457 • Number of events 168 • From enrollment until the end of follow-up, up to 24 weeks	0.00% 0/279 • From enrollment until the end of follow-up, up to 24 weeks

Additional Information

Sarang Yoon, PI

University of Utah

Phone: 801-203-0320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place