Fernando P. Polack , M.D., Stephen J. Thomas , M.D., Nicholas Kitchin , M.D., Judith Absalon , M.D., Alejandra Gurtman , M.D., Stephen Lockhart , D.M., John L. Perez , M.D., Gonzalo Pérez Marc , M.D., Edson D. Moreira , M.D., Cristiano Zerbini , M.D., Ruth Bailey , B.Sc., Kena A. Swanson , Ph.D., Satrajit Roychoudhury , Ph.D., Kenneth Koury , Ph.D., Ping Li , Ph.D., Warren V. Kalina , Ph.D., David Cooper , Ph.D., Robert W. Frenck Jr. , M.D., Laura L. Hammitt , M.D., Özlem Türeci , M.D., Haylene Nell , M.D., Axel Schaefer , M.D., Serhat Ünal , M.D., Dina B. Tresnan , D.V.M., Ph.D., Susan Mather , M.D., Philip R. Dormitzer , M.D., Ph.D., Uğur Şahin , M.D., Kathrin U. Jansen , Ph.D., William C. Gruber , M.D. *
10 December 2020
Keyword part (code): 4Keyword part (keyword): PediatricsKeyword part (code): 4_6Keyword part (keyword): Immunization , 4, Pediatrics, Keyword part (code): 4_6Keyword part (keyword): Immunization, 4_6, Immunization, Keyword part (code): 18Keyword part (keyword): Infectious DiseaseKeyword part (code): 18_2Keyword part (keyword): VaccinesKeyword part (code): 18_6Keyword part (keyword): Viral Infections , 18, Infectious Disease, Keyword part (code): 18_2Keyword part (keyword): VaccinesKeyword part (code): 18_6Keyword part (keyword): Viral Infections , 18_2, Vaccines, 18_6, Viral Infections, Keyword part (code): 24Keyword part (keyword): Health PolicyKeyword part (code): 24_9Keyword part (keyword): Drugs, Devices, and the FDA , 24, Health Policy, Keyword part (code): 24_9Keyword part (keyword): Drugs, Devices, and the FDA, 24_9, Drugs, Devices, and the FDA
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.
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.
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.
A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)