A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years

Summary

The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19. This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. 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 a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.

Timeline

Start

2025-07-08

Primary completion

2026-05-01

Completion

2026-05-01

Publications

• Dadhe R, Gayed J, Iqbal M, Solan R, Wu H, Ma H, Xu X, Mensa FJ, Belanger T, Cooper D, Mogg R, Anderson AS, Tureci O, Sahin U, Allen PS, Modjarrad K, Gurtman A, Lindert K. A Study to Investigate the Safety and Immunogenicity of Monovalent Omicron LP.8.1-Adapted BNT162b2 COVID-19 Vaccine in Adults >/= 65 Years of Age and High-Risk Adults 18-64 Years of Age (Preliminary Results). Vaccines (Basel). 2026 Apr 15;14(4):350. doi: 10.3390/vaccines14040350.

Drugs

Indications