Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

TY - JOUR

T1 - Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

AU - Polack, Fernando P

AU - Thomas, Stephen J

AU - Kitchin, Nicholas

AU - Absalon, Judith

AU - Gurtman, Alejandra

AU - Lockhart, Stephen

AU - Perez, John L

AU - Perez Marc, Gonzalo

AU - Moreira, Edson D

AU - Zerbini, Christiano

AU - Bailey, Ruth

AU - Swanson, Kena A

AU - Roychoudhury, Satrajit

AU - Koury, Kenneth

AU - Li, Ping

AU - Kalina, Warren V

AU - Cooper, David

AU - Frenck Jr, Robert W

AU - Hammitt, Laura L

AU - Türeci, Özlem

AU - Nell, Haylene

AU - Schaefer, Axel

AU - Ünal, Serhat

AU - Tresnan, Dina B

AU - Mather, Susan

AU - Dormitzer, Philip R

AU - Sahin, Ugur

AU - Jansen, Kathrin U

AU - Gruber, William C

AU - C4591001 Clinical Trial Group

AU - Addo, Marylyn Martina

PY - 2020/12/31

Y1 - 2020/12/31

N2 - 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.MethodsIn 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.ResultsA 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.ConclusionsA 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.).

AB - 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.MethodsIn 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.ResultsA 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.ConclusionsA 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.).

KW - Adolescent

KW - Adult

KW - Aged

KW - COVID-19/immunology

KW - COVID-19 Vaccines/administration & dosage

KW - Fatigue/etiology

KW - Female

KW - Headache/etiology

KW - Humans

KW - Immunization, Secondary

KW - Male

KW - Middle Aged

KW - SARS-CoV-2/genetics

KW - Single-Blind Method

KW - Treatment Outcome

KW - Vaccines, Synthetic

KW - Young Adult

UR - https://europepmc.org/articles/PMC7745181

U2 - 10.1056/nejmoa2034577

DO - 10.1056/nejmoa2034577

M3 - SCORING: Journal article

C2 - 33301246

VL - 383

SP - 2603

EP - 2615

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 27

ER -