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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
general
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults
Nature, Volume 586, No. 7830, Year 2020
Notification
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Description
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. © 2020, The Author(s), under exclusive licence to Springer Nature Limited.
Authors & Co-Authors
Mulligan, Mark J.
United States, New York
Nyu Langone Health
United States, New York
Nyu Grossman School of Medicine
Lyke, Kirsten E.
United States, Baltimore
University of Maryland School of Medicine
Kitchin, Nicholas R.E.
United Kingdom, Tadworth
Pfizer Limited, uk
Absalon, Judith
United States, New York
Pfizer Inc.
Gurtman, Alejandra C.
United States, New York
Pfizer Inc.
Lockhart, Stephen P.
United Kingdom, Tadworth
Pfizer Limited, uk
Neuzil, Kathleen Maletic
United States, Baltimore
University of Maryland School of Medicine
Raabe, Vanessa N.
United States, New York
Nyu Langone Health
United States, New York
Nyu Grossman School of Medicine
Bailey, Ruth
United Kingdom, Tadworth
Pfizer Limited, uk
Swanson, Kena A.
United States, New York
Pfizer Inc.
Li, Ping
United States, New York
Pfizer Inc.
Koury, Kenneth J.
United States, New York
Pfizer Inc.
Kalina, Warren Vincent
United States, New York
Pfizer Inc.
Cooper, David A.
United States, New York
Pfizer Inc.
Türeci, Özlem
Germany, Mainz
Biontech se
Walsh, Edward E.
United States, Rochester
University of Rochester
United States, Rochester
Rochester General Hospital
Frenck, Robert W.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Falsey, Ann Regina
United States, Rochester
University of Rochester
United States, Rochester
Rochester General Hospital
Dormitzer, Philip Ralph
United States, New York
Pfizer Inc.
Gruber, William C.
United States, New York
Pfizer Inc.
Şahin, Uǧur
Germany, Mainz
Biontech se
Jansen, Kathrin Ute
United States, New York
Pfizer Inc.
Statistics
Citations: 1,011
Authors: 22
Affiliations: 10
Identifiers
Doi:
10.1038/s41586-020-2639-4
ISSN:
00280836
Research Areas
Covid