Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents

作者：Robert W. Frenck, Nicola P. Klein, Nicholas R.E. Kitchin, Alejandra Gurtman, Judith Absalon, Stephen P. Lockhart, John L. Perez, Emmanuel B. Walter, Shelly David Senders, Ruth E. Bailey, Kena A. Swanson, Hua Ma, Xia Xu, Kenneth J. Koury, Warren V. Kalina, David A. Cooper, Timothy W Jennings, Donald M. Brandon, Stephen James Thomas, Özlem Türeci, Dina B Tresnan, Susan Mather, Philip R. Dormitzer, Uğur Şahin, Kathrin U. Jansen, William C. Gruber · 发表于：New England Journal of Medicine · 年份：2021 · DOI：10.1056/nejmoa2107456 · 被引用次数：938 · 研究领域：SARS-CoV-2 and COVID-19 Research、Vaccine Coverage and Hesitancy、vaccines and immunoinformatics approaches

BACKGROUND: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity. METHODS: In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year-old cohort were assessed. RESULTS: Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old part...