A Phase 3 interventional study of BNT162b2 and BNT162b2 in COVID-19 Vaccines, sponsored by BioNTech SE. Not yet recruiting. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by BioNTech SE · Phase 3, Interventional, and Prevention
The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.
This study is seeking participants who:
Participants in Cohort 1 of this study will receive 1 injection into their arm of BNT162b2 vaccine 1 which targets COVID-19. The study team and participants will know which injection they receive.
Participants in Cohort 2 of this study will randomly receive 1 injection into their arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.
Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.
Key Inclusion criteria:
Key Exclusion Criteria:
Refer to the study contact for further eligibility details.
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
Biological: BNT162b2
BNT162b2 vaccine 1
BNT162b2 vaccine 2
BNT162b2 vaccine 3
Percentage of participants reporting local reactions or systemic events
Time frame: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time frame: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Time frame: Through 6 months after vaccination
Geometric Mean Fold Rise (GMFRs)
Time frame: From baseline to 1 month after vaccination
Geometric Mean Titers (GMTs)
Time frame: At baseline and at 1 month after vaccination
Percentage of participants with seroresponse
Time frame: At 1 month after vaccination
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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BioNTech SE