CompletedPhase 3

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

United States774 participantsStarted 2025-07-08

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants reporting local reactions

Timeframe: For up to 7 days after vaccination

Percentage of participants reporting systemic events

Timeframe: For up to 7 days after vaccination

Percentage of participants reporting adverse events

Timeframe: Through 1 month after vaccination

Percentage of participants reporting serious adverse events

Timeframe: Through 6 months after vaccination

Cohort 1: Geometric Mean Titers (GMTs)

Timeframe: At 2 weeks after vaccination

Cohort 1: Geometric Mean Fold Rises (GMFRs)

Timeframe: From before vaccination to 2 weeks after vaccination

Cohort 1: Percentages of participants with seroresponse

Timeframe: 2 weeks after vaccination

Trial details

NCT IDNCT07069309

SponsorBioNTech SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of participants reporting local reactions

Timeframe: For up to 7 days after vaccination

Percentage of participants reporting systemic events

Timeframe: For up to 7 days after vaccination

Percentage of participants reporting adverse events

Timeframe: Through 1 month after vaccination

Percentage of participants reporting serious adverse events

Timeframe: Through 6 months after vaccination

Cohort 1: Geometric Mean Titers (GMTs)

Timeframe: At 2 weeks after vaccination

Cohort 1: Geometric Mean Fold Rises (GMFRs)

Timeframe: From before vaccination to 2 weeks after vaccination

Cohort 1: Percentages of participants with seroresponse

Timeframe: 2 weeks after vaccination