Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.

Abstract

BACKGROUND:

BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.

METHODS:

In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.

RESULTS:

BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.

CONCLUSIONS:

Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).

• Authors: Stephen J Thomas, Edson D Moreira Jr, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L Perez, Gonzalo Pérez Marc, Fernando P Polack, Cristiano Zerbini, Ruth Bailey, Kena A Swanson, Xia Xu, Satrajit Roychoudhury, Kenneth Koury, Salim Bouguermouh, Warren V Kalina, David Cooper, Robert W Frenck Jr, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Qi Yang, Paul Liberator, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, William C Gruber, Kathrin U Jansen, C4591001 Clinical Trial Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 385 Issue 19 Pg. 1761-1773 (11 04 2021) ISSN: 1533-4406 [Electronic] United States
• PMID: 34525277 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 Massachusetts Medical Society.

Chemical References

• Antibodies, Viral
• COVID-19 Vaccines
• BNT162 Vaccine

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Viral (analysis)
• BNT162 Vaccine
• COVID-19 (epidemiology, prevention & control)
• COVID-19 Vaccines (adverse effects, immunology)
• Child
• Female
• Follow-Up Studies
• Humans
• Immunization, Secondary
• Immunogenicity, Vaccine
• Incidence
• Male
• Middle Aged
• SARS-CoV-2 (immunology)
• Single-Blind Method
• Treatment Outcome
• Young Adult