Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, Gonzalo Pérez Marc, Edson D. Moreira, Cristiano Zerbini, William C. Gruber · C4591001 Clinical Trial Group
Summary
This multinational, randomized, placebo-controlled phase 2/3 trial evaluated the safety and efficacy of two 30-µg doses of the BNT162b2 lipid-nanoparticle mRNA vaccine, given 21 days apart, in 43,548 participants 16 years of age or older. Among those without prior SARS-CoV-2 infection, the vaccine conferred 95% protection against laboratory-confirmed Covid-19 beginning at least 7 days after the second dose. The safety profile over a median of about two months was characterized by short-lived, mostly mild-to-moderate reactions, with a low incidence of serious adverse events comparable to placebo.
Key findings
- A two-dose regimen of BNT162b2 conferred 95% efficacy against confirmed Covid-19 (8 cases in vaccine recipients vs. 162 in the placebo group) in persons 16 years of age or older.
- Efficacy was broadly consistent across subgroups defined by age, sex, race, ethnicity, body-mass index, and presence of coexisting conditions.
- Reactogenicity was generally short-lived (most commonly injection-site pain, fatigue, and headache), and the incidence of serious adverse events was low and similar between the vaccine and placebo groups.
Subjects & keywords
Cite this paper
Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, Gonzalo Pérez Marc, Edson D. Moreira, Cristiano Zerbini, & William C. Gruber [C4591001 Clinical Trial Group] (2020). Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2034577
@article{polack2020safety,
author = {Fernando P. Polack and Stephen J. Thomas and Nicholas Kitchin and Judith Absalon and Alejandra Gurtman and Stephen Lockhart and John L. Perez and Gonzalo Pérez Marc and Edson D. Moreira and Cristiano Zerbini and William C. Gruber and {C4591001 Clinical Trial Group}},
title = {Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine},
journal = {New England Journal of Medicine},
year = {2020},
doi = {10.1056/NEJMoa2034577},
url = {https://doi.org/10.1056/NEJMoa2034577}
}