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

Abstract

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.

CONCLUSIONS:

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.).

• Authors: 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, Ruth Bailey, Kena A Swanson, Satrajit Roychoudhury, Kenneth Koury, Ping Li, Warren V Kalina, David Cooper, Robert W Frenck Jr, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, Kathrin U Jansen, William C Gruber, C4591001 Clinical Trial Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 383 Issue 27 Pg. 2603-2615 (12 31 2020) ISSN: 1533-4406 [Electronic] United States
• PMID: 33301246 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Massachusetts Medical Society.

Chemical References

• COVID-19 Vaccines
• Vaccines, Synthetic
• BNT162 Vaccine

Topics

• Adolescent
• Adult
• Aged
• BNT162 Vaccine
• COVID-19 (immunology, prevention & control)
• COVID-19 Vaccines (administration & dosage, adverse effects, immunology)
• Fatigue (etiology)
• Female
• Headache (etiology)
• Humans
• Immunization, Secondary
• Male
• Middle Aged
• SARS-CoV-2 (genetics)
• Single-Blind Method
• Treatment Outcome
• Vaccines, Synthetic
• Young Adult
• mRNA Vaccines