The purpose of this study is to learn about the safety, tolerability, and immunogenicityof an updated vaccine against COVID-19.This study is seeking participants 12 through 64 years of age who are considered to be athigher risk for severe COVID-19 disease per study protocol and those 65 years of age andolder. All participants in this study will receive 1 shot to their arm of a BNT162b2(2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets acirculating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratoryvirus season. This study is about 6 months for each participant. Participants will eitherbe enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participantsenrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2will have at least 3 visits.
Not Provided
Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Inclusion criteria:
- Cohort 1: Participants 18 years of age or older.
- Cohort 2: Participants 12 years of age or older.
- Participants 12 through 64 years of age with at least 1 underlying medical condition
that increases their risk of severe COVID-19.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).
- History of myocarditis or pericarditis.
- Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed
by signs/symptoms and/or a positive test result based on local testing) less than 5
months (150 days) prior to study enrollment.
Refer to the study contact for further eligibility details.
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
DM Clinical Research- Cyfair
Houston, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Pfizer CT.gov Call Center, Study Director
Pfizer