Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine

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Stephen J. ThomasEdson D. Moreira Jr.Nicholas KitchinJudith AbsalonAlejandra GurtmanStephen LockhartJohn L. PerezGonzalo Pérez MarcFernando P. PolackCristiano ZerbiniRuth BaileyKena A. SwansonXia XuSatrajit RoychoudhuryKenneth KourySalim BouguermouhWarren V. KalinaDavid CooperRobert W. Frenck Jr.Laura L. HammittÖzlem TüreciHaylene NellAxel SchaeferSerhat ÜnalQi YangPaul LiberatorDina B. TresnanSusan MatherPhilip R. DormitzerUğur ŞahinWilliam C. GruberKathrin U. JansenC4591001 Clinical Trial Group


Background BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. BNT162b2 is highly efficacious against COVID-19 and is currently authorized for emergency use or conditional approval worldwide. At the time of authorization, data beyond 2 months post-vaccination were unavailable.

Methods In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy study, 44,165 ≥16-year-old participants and 2,264 12-15-year-old participants were randomized to receive 2 doses, 21 days apart, of 30 µg BNT162b2 or placebo. Study endpoints reported here are vaccine efficacy (VE) against laboratory-confirmed COVID-19 and safety data, both up to 6 months post-vaccination.

Results BNT162b2 continued to be safe and well tolerated. Few participants had adverse events leading to study withdrawal. VE against COVID-19 was 91% (95% CI 89.0-93.2) through up to 6 months of follow-up, among evaluable participants and irrespective of previous SARS-CoV-2 infection. VE of 86%-100% was seen across countries and in populations with diverse characteristics of age, sex, race/ethnicity, and COVID-19 risk factors in participants without evidence of previous SARS-CoV-2 infection. VE against severe disease was 97% (95% CI 80.3−99.9). In South Africa, where the SARS-CoV-2 variant of concern, B.1.351 (beta), was predominant, 100% (95% CI 53.5, 100.0) VE was observed.

Conclusion With up to 6 months of follow-up and despite a gradually declining trend in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing COVID-19. ( number, NCT04368728)

Competing Interest Statement

All authors have completed the ICMJE uniform disclosure form at

Clinical Trial


Funding Statement

Supported by BioNTech and Pfizer.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.


The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The trial was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the International Council for Harmonisation Good Clinical Practice Guidelines, the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, and applicable laws and regulations (including applicable privacy laws). An independent data monitoring committee reviewed efficacy and unblinded safety data. Institutional Review Board or Ethics Committee approval was obtained for each site prior to enrollment of any study participant. The list of Institutional Review Board Committees is summarized at the end of the Supplementary Appendix.

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.


I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).


I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.


Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bio


Mikael Nordfors's picture


During the blinded, controlled period, 15 BNT162b2 and 14 placebo recipients died; during the open-label period, 3 BNT162b2 and 2 original placebo recipients who received BNT162b2 after unblinding died. None of these deaths were considered related to BNT162b2 by investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4)

(This is 15+5 = 20 versus 14.) I have without success also tried to find Table S4 in the document...

Safe and effective? With higher overall mortality in the "vaccine" group,