Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

作者：Emmanuel B. Walter, Kawsar R. Talaat, Charu Sabharwal, Alejandra Gurtman, Stephen Lockhart, Grant Paulsen, Elizabeth D. Barnett, Flor M. Muñoz, Yvonne Maldonado, Barbara Pahud, Joseph B. Domachowske, Eric A. F. Simões, Uzma Sarwar, Nicholas Kitchin, Luke Cunliffe, Pablo Rojo, Ernest Kuchar, Mika Rämet, Iona Munjal, John L. Perez, Robert W. Frenck, Eleni Lagkadinou, Kena A. Swanson, Hua Ma, Xia Xu, Kenneth Koury, Susan Mather, Todd Belanger, David Cooper, Özlem Türeci, 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/nejmoa2116298 · 被引用次数：628 · 研究领域：SARS-CoV-2 and COVID-19 Research、Vaccine Coverage and Hesitancy、Immune responses and vaccinations

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. RESULTS: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No...