13 January 2021Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (IF: NEJM, 70.

13 January 2021

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (IF: NEJM, 70.670)

BACKGROUND 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.

severe acute respiratory syndrome coronavirus type 2 (SARS-CoV -2) The infection and the resulting coronavirus disease 2019 (Covid-19) pandemic have affected tens of millions of people around the world. There is an urgent need for safe and effective vaccines.

METHODS

In an ongoing, 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.

In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomized 16 years or older in a 1:1 ratio People received two doses of placebo or the BNT162b2 vaccine candidate (30 micrograms per dose) 21 days apart. BNT162b2 is a lipid nanoparticle formulation, nucleoside-modified RNA vaccine encoding prefusion-stable, membrane-anchored SARS-CoV-2 full-length spike protein. The primary endpoints are laboratory-confirmed efficacy and safety of the Covid-19 vaccine.

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 BNT162 b2 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 total of 43,548 participants underwent randomization, of which 43,448 People received the injection: 21,720 received BNT162b2 and 21,728 received placebo. Eight of the subjects who received a second dose of BNT162b2 developed Covid-19 at least 7 days after the second dose, compared with 162 of those who received a placebo; BNT162b2 Prevents Covid The effective rate of -19 is 95% (95% confidence interval is 90.3~97.6).Similar vaccine efficacy (generally 90% to 100%) was observed in subgroups defined by age, sex, race, ethnicity, baseline body mass index, and comorbid conditions. Of the 10 cases of severe Covid-19 that developed after the first dose, 9 occurred in placebo subjects and 1 occurred in BNT162b2 subjects. The safety profile of BNT162b2 was short-term, mild to moderate injection site pain, fatigue and headache. The incidence of serious adverse events was low and 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.

BNT162b2 Provides 95% protection against Covid-19 in people aged 10 years or older. The average 2-month safety profile is similar to other viral vaccines.