A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults

Miwa Haranaka, James Baber (), Yoichiro Ogama, Masako Yamaji, Masakazu Aizawa, Osamu Kogawara, Ingrid Scully, Eleni Lagkadinou, Ӧzlem Türeci, Uğur Şahin, Philip R. Dormitzer, William C. Gruber and Stephen Lockhart
Additional contact information
Miwa Haranaka: SOUSEIKAI PS Clinic
James Baber: Vaccine Clinical Research, Pfizer Inc
Yoichiro Ogama: SOUSEIKAI Sumida Hospital
Masako Yamaji: Pfizer R&D Japan G.K.
Masakazu Aizawa: Pfizer R&D Japan G.K.
Osamu Kogawara: Pfizer R&D Japan G.K.
Ingrid Scully: Vaccine Research and Development, Pfizer Inc
Eleni Lagkadinou: BioNTech
Ӧzlem Türeci: BioNTech
Uğur Şahin: BioNTech
Philip R. Dormitzer: Vaccine Research and Development, Pfizer Inc
William C. Gruber: Vaccine Research and Development, Pfizer Inc
Stephen Lockhart: Vaccine Research and Development, Pfizer Inc

Nature Communications, 2021, vol. 12, issue 1, 1-7

Abstract: Abstract 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).

Date: 2021
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-021-27316-2 Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:12:y:2021:i:1:d:10.1038_s41467-021-27316-2

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-021-27316-2

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().