Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine
Open accessPreprint — published as 10.1056/nejmoa2110345 · Paper page
Abstract
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. ( ClinicalTrials.gov number, NCT04368728 )
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Vaccine-induced immunity remains effective at preventing severe disease, hospitalization, and death even at later time points when antibody levels may have declined.
“Yet, vaccine-induced immunity remains effective at preventing severe disease, hospitalization, and death, even at later time points when antibody levels may have declined (10–12).”
From mRNA vaccines induce durable immune memory to SARS-CoV-2 and variants of concern (2021) · cites this paper as [12]
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
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- Authors
- Thomas, S. J., Moreira, E. D., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Polack, F. P., Zerbini, C., Bailey, R., Swanson, K. A., Xu, X., Roychoudhury, S., Koury, K., Bouguermouh, S., Kalina, W. V., Cooper, D., Frenck, R. W., Hammitt, L. L., Türeci, Ö., Nell, H., Schaefer, A., Ünal, S., Yang, Q., Liberator, P., Tresnan, D. B., Mather, S., Dormitzer, P. R., Şahin, U., Gruber, W. C., Jansen, K. U., & C4591001 Clinical Trial Group
- Affiliations
- Pfizer (United States) (US)
- Corresponding author
- Absalon, Judith
- Venue
- New England Journal of Medicine
- Publisher
- openRxiv
- Published
- 2021-07-28
- Volume
- 385
- Issue
- 19
- Pages
- 1761-1773
- ISSN
- 0028-4793 (ISSN-L)
- PMC
- PMC8461570
- OpenAlex
- W3200157219
- Cited by
- 1,640
- References
- 1
- Citations by year
- 2026: 57 · 2025: 141 · 2024: 212 · 2023: 343 · 2022: 654 · 2021: 229 · 2020: 1
- FWCI
- 114.02
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- New England Journal of Medicine (publishedVersion)
- medRxiv (acceptedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- BNT162b2, COVID-19 vaccines, SARS-CoV-2 spike protein, mRNA vaccines, lipid nanoparticle formulation, vaccine efficacy, vaccine safety, long-term follow-up, waning immunity, severe COVID-19 prevention, B.1.351 variant, emergency use authorization, children and adolescents, adverse events, trial discontinuation
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Viral, Child, Female, Follow-Up Studies, Humans, Immunization, Secondary, Male, Middle Aged, Incidence, Single-Blind Method, Treatment Outcome, Young Adult
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