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.
Biological: BNT162b2
BNT162b2 (intramuscular injection)
Other: Placebo
Placebo (intramuscular injection)
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.
SOUSEIKAI Sumida Hospital
Sumida-ku, Tokyo, Japan
SOUSEIKAI PS Clinic
Fukuoka, Japan
Pfizer CT.gov Call Center, Study Director
Pfizer