From protocol amendment 3, this study is transitioned from a clinical trial to a postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was approved by the Ministry of Health, Labour and Welfare on 14 February 2021.
This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.~The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:~As 2 doses, separated by 21 days~At a single dose level~In adults 20 to 85 years of age