A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults.
Nat Commun
; 12(1): 7105, 2021 12 14.
Article
in English
| MEDLINE | ID: covidwho-1574494
ABSTRACT
We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 31 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).
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Immunogenicity, Vaccine
/
COVID-19 Vaccines
/
COVID-19
/
BNT162 Vaccine
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
/
Young adult
Country/Region as subject:
Asia
Language:
English
Journal:
Nat Commun
Journal subject:
Biology
/
Science
Year:
2021
Document Type:
Article
Affiliation country:
S41467-021-27316-2
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