study to evaluate the safety, tolerability, and immunogenicity of an rna vaccine candidate against covid-19 in healthy japanese adults

Conditions: SARS-CoV-2 Infection; COVID-19

Summary: 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

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.

Eligibility criteria:
inclusion criteria: * japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization. * participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. * healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * capable of giving personal signed informed consent. exclusion criteria: * other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * known infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b virus (hbv). * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). * receipt of medications intended to prevent covid-19. * previous confirmed diagnosis of covid-19. * immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * women who are pregnant or breastfeeding. * previous vaccination with any coronavirus vaccine. * individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. * receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. * participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. * previous participation in other studies involving study intervention containing lipid nanoparticles. * subset only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ grade 1 abnormality. * investigator site staff or pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.