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In March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. With rapidly accumulating cases and deaths reported globally2, a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.
Phase 1/2 Study of COVID-19 RNA Vaccine BNT162b1 in Adults
Nature 2020 Aug 12;[EPub Ahead of Print], MJ Mulligan, KE Lyke, N Kitchin, J Absalon, A Gurtman, S Lockhart, K Neuzil, V Raabe, R Bailey, KA Swanson, P Li, K Koury, W Kalina, D Cooper, C Fontes-Garfias, PY Shi, Ö Türeci, KR Tompkins, EE Walsh, R Frenck, AR Falsey, PR Dormitzer, WC Gruber, U Şahin, KU Jansen