Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Type Journal Article Author Fernando P. Polack Author Stephen J. Thomas Author Nicholas Kitchin Author Judith Absalon Author Alejandra Gurtman Author Stephen Lockhart Author John L. Perez Author Gonzalo Pérez Marc Author Edson D. Moreira Author Cristiano Zerbini Author Ruth Bailey Author Kena A. Swanson Author Satrajit Roychoudhury Author Kenneth Koury Author Ping Li Author Warren V. Kalina Author David Cooper Author Jr Robert W. Frenck Author Laura L. Hammitt Author Özlem Türeci Author Haylene Nell Author Axel Schaefer Author Serhat Ünal Author Dina B. Tresnan Author Susan Mather Author Philip R. Dormitzer Author Uğur Şahin Author Kathrin U. Jansen Author William C. Gruber URL https://www.nejm.org/doi/10.1056/NEJMoa2034577 Rights Copyright © 2020 Massachusetts Medical Society. All rights reserved. Publication New England Journal of Medicine Date 10/12/2020 Loc. in Archive world Extra Publisher: Massachusetts Medical Society DOI 10.1056/NEJMoa2034577 Library Catalog www.nejm.org Language en Abstract Original Article from The New England Journal of Medicine — Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.