Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

Mark J. Mulligan, Kirsten E. Lyke, Nicholas Kitchin, Judith Absalon (), Alejandra Gurtman, Stephen Lockhart, Kathleen Neuzil, Vanessa Raabe, Ruth Bailey, Kena A. Swanson, Ping Li, Kenneth Koury, Warren Kalina, David Cooper, Camila Fontes-Garfias, Pei-Yong Shi, Özlem Türeci, Kristin R. Tompkins, Edward E. Walsh, Robert Frenck, Ann R. Falsey, Philip R. Dormitzer, William C. Gruber, Uğur Şahin and Kathrin U. Jansen
Additional contact information
Mark J. Mulligan: New York University Langone Vaccine Center
Kirsten E. Lyke: University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Nicholas Kitchin: Vaccine Research and Development, Pfizer Inc
Judith Absalon: Vaccine Research and Development, Pfizer Inc
Alejandra Gurtman: Vaccine Research and Development, Pfizer Inc
Stephen Lockhart: Vaccine Research and Development, Pfizer Inc
Kathleen Neuzil: University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Vanessa Raabe: New York University Langone Vaccine Center
Ruth Bailey: Vaccine Research and Development, Pfizer Inc
Kena A. Swanson: Vaccine Research and Development, Pfizer Inc
Ping Li: Vaccine Research and Development, Pfizer Inc
Kenneth Koury: Vaccine Research and Development, Pfizer Inc
Warren Kalina: Vaccine Research and Development, Pfizer Inc
David Cooper: Vaccine Research and Development, Pfizer Inc
Camila Fontes-Garfias: University of Texas Medical Branch
Pei-Yong Shi: University of Texas Medical Branch
Özlem Türeci: BioNTech
Kristin R. Tompkins: Vaccine Research and Development, Pfizer Inc
Edward E. Walsh: University of Rochester
Robert Frenck: Cincinnati Children’s Hospital
Ann R. Falsey: University of Rochester
Philip R. Dormitzer: Vaccine Research and Development, Pfizer Inc
William C. Gruber: Vaccine Research and Development, Pfizer Inc
Uğur Şahin: BioNTech
Kathrin U. Jansen: Vaccine Research and Development, Pfizer Inc

Nature, 2020, vol. 586, issue 7830, 589-593

Abstract: Abstract In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1, a pandemic. With rapidly accumulating numbers of cases and deaths reported globally2, a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18–55 years of age), who were randomized to receive 2 doses—separated by 21 days—of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9–4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.

Date: 2020
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DOI: 10.1038/s41586-020-2639-4

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