tetano
Editor, Senior Moderator
N Engl J Med
. 2020 Dec 10.
doi: 10.1056/NEJMoa2034577. Online ahead of print.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P Polack[SUP] 1 [/SUP], Stephen J Thomas[SUP] 1 [/SUP], Nicholas Kitchin[SUP] 1 [/SUP], Judith Absalon[SUP] 1 [/SUP], Alejandra Gurtman[SUP] 1 [/SUP], Stephen Lockhart[SUP] 1 [/SUP], John L Perez[SUP] 1 [/SUP], Gonzalo P?rez Marc[SUP] 1 [/SUP], Edson D Moreira[SUP] 1 [/SUP], Cristiano Zerbini[SUP] 1 [/SUP], Ruth Bailey[SUP] 1 [/SUP], Kena A Swanson[SUP] 1 [/SUP], Satrajit Roychoudhury[SUP] 1 [/SUP], Kenneth Koury[SUP] 1 [/SUP], Ping Li[SUP] 1 [/SUP], Warren V Kalina[SUP] 1 [/SUP], David Cooper[SUP] 1 [/SUP], Robert W Frenck Jr[SUP] 1 [/SUP], Laura L Hammitt[SUP] 1 [/SUP], ?zlem T?reci[SUP] 1 [/SUP], Haylene Nell[SUP] 1 [/SUP], Axel Schaefer[SUP] 1 [/SUP], Serhat ?nal[SUP] 1 [/SUP], Dina B Tresnan[SUP] 1 [/SUP], Susan Mather[SUP] 1 [/SUP], Philip R Dormitzer[SUP] 1 [/SUP], Uğur Şahin[SUP] 1 [/SUP], Kathrin U Jansen[SUP] 1 [/SUP], William C Gruber[SUP] 1 [/SUP], C4591001 Clinical Trial Group
Affiliations
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.).
. 2020 Dec 10.
doi: 10.1056/NEJMoa2034577. Online ahead of print.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P Polack[SUP] 1 [/SUP], Stephen J Thomas[SUP] 1 [/SUP], Nicholas Kitchin[SUP] 1 [/SUP], Judith Absalon[SUP] 1 [/SUP], Alejandra Gurtman[SUP] 1 [/SUP], Stephen Lockhart[SUP] 1 [/SUP], John L Perez[SUP] 1 [/SUP], Gonzalo P?rez Marc[SUP] 1 [/SUP], Edson D Moreira[SUP] 1 [/SUP], Cristiano Zerbini[SUP] 1 [/SUP], Ruth Bailey[SUP] 1 [/SUP], Kena A Swanson[SUP] 1 [/SUP], Satrajit Roychoudhury[SUP] 1 [/SUP], Kenneth Koury[SUP] 1 [/SUP], Ping Li[SUP] 1 [/SUP], Warren V Kalina[SUP] 1 [/SUP], David Cooper[SUP] 1 [/SUP], Robert W Frenck Jr[SUP] 1 [/SUP], Laura L Hammitt[SUP] 1 [/SUP], ?zlem T?reci[SUP] 1 [/SUP], Haylene Nell[SUP] 1 [/SUP], Axel Schaefer[SUP] 1 [/SUP], Serhat ?nal[SUP] 1 [/SUP], Dina B Tresnan[SUP] 1 [/SUP], Susan Mather[SUP] 1 [/SUP], Philip R Dormitzer[SUP] 1 [/SUP], Uğur Şahin[SUP] 1 [/SUP], Kathrin U Jansen[SUP] 1 [/SUP], William C Gruber[SUP] 1 [/SUP], C4591001 Clinical Trial Group
Affiliations
- PMID: 33301246
- DOI: 10.1056/NEJMoa2034577
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.).