A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults.
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
14 12 2021
14 12 2021
Historique:
received:
02
08
2021
accepted:
12
11
2021
entrez:
15
12
2021
pubmed:
16
12
2021
medline:
6
1
2022
Statut:
epublish
Résumé
We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160 individuals were randomized: 119 received BNT162b2, and 41 received placebo. Participants were stratified by age: 20-64 years (n = 130) and 65-85 years (n = 30). More than 97% of BNT162b2 recipients received 2 doses. Local reactions and systemic events were generally transient and mild to moderate. Severe adverse events were uncommon; there were no serious adverse events. One month after dose 2, SARS-CoV-2 50% serum neutralizing geometric mean titers were 571 and 366, and geometric mean fold rises were 55.8 and 36.6, in the younger and older age groups, respectively. In summary, BNT162b2 has an acceptable safety profile and produces a robust immune response, regardless of age, in Japanese adults. (ClinicalTrials.gov, NCT04588480).
Identifiants
pubmed: 34907170
doi: 10.1038/s41467-021-27316-2
pii: 10.1038/s41467-021-27316-2
pmc: PMC8671474
doi:
Substances chimiques
COVID-19 Vaccines
0
BNT162 Vaccine
N38TVC63NU
Banques de données
ClinicalTrials.gov
['NCT04588480']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
7105Subventions
Organisme : Pfizer (Pfizer Inc.)
ID : n/a
Informations de copyright
© 2021. The Author(s).
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