Emmanuel B Walter, Kawsar R Talaat, Charu Sabharwal, Alejandra Gurtman, Stephen Lockhart, Grant C Paulsen, Elizabeth D Barnett, Flor M Muñoz, Yvonne Maldonado, Barbara A Pahud, Joseph B Domachowske, Eric A F Simões, Uzma N 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 J Belanger, David Cooper, Özlem Türeci, Philip R Dormitzer, Uğur Şahin, Kathrin U Jansen, William C Gruber
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...
January 6, 2022: New England Journal of Medicine