{"doi":"10.1056/nejmoa2034577","title":"Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine","abstract":"<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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. 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Swanson","orcid":"0000-0002-3389-8414","position":11,"is_corresponding":false},{"id":65339,"name":"Satrajit Roychoudhury","orcid":"0000-0003-4001-3036","position":12,"is_corresponding":false},{"id":38199,"name":"Kenneth Koury","orcid":null,"position":13,"is_corresponding":false},{"id":352,"name":"Ping Li","orcid":"0000-0003-4150-3758","position":14,"is_corresponding":false},{"id":38213,"name":"Warren V. Kalina","orcid":null,"position":15,"is_corresponding":false},{"id":38201,"name":"David Cooper","orcid":"0000-0002-4595-3943","position":16,"is_corresponding":false},{"id":38190,"name":"Robert W. Frenck","orcid":"0000-0002-2336-526X","position":17,"is_corresponding":false},{"id":65340,"name":"Laura L. Hammitt","orcid":null,"position":18,"is_corresponding":false},{"id":38204,"name":"Özlem Türeci","orcid":"0000-0002-0623-1497","position":19,"is_corresponding":false},{"id":65341,"name":"Haylene Nell","orcid":null,"position":20,"is_corresponding":false},{"id":65342,"name":"Axel Schaefer","orcid":null,"position":21,"is_corresponding":false},{"id":65343,"name":"Serhat Ünal","orcid":"0000-0003-1184-4711","position":22,"is_corresponding":false},{"id":65344,"name":"Dina B. Tresnan","orcid":null,"position":23,"is_corresponding":false},{"id":65345,"name":"Susan Mather","orcid":null,"position":24,"is_corresponding":false},{"id":38208,"name":"Philip R. Dormitzer","orcid":"0000-0003-0671-6360","position":25,"is_corresponding":false},{"id":38210,"name":"Uğur Şahin","orcid":"0000-0003-0363-1564","position":26,"is_corresponding":false},{"id":38209,"name":"Kathrin U. Jansen","orcid":"0000-0001-7818-8996","position":27,"is_corresponding":false},{"id":38211,"name":"William C. 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