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

BioNTech

Status and phase: Active, not recruiting; Phase 3

Conditions: COVID-19; SARS-COV-2 Infection

Treatments: Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07069309

C4591076

Details and patient eligibility

About

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.

Enrollment: 760 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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760 participants in 4 patient groups

Group 1: 18 through 64 years of age (higher-risk individuals)

Experimental group

Description:

Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1

Treatment:

Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

Group 2: 65 years of age and older

Experimental group

Description:

Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1

Treatment:

Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

Group 3: 12 through 64 years of age (higher-risk individuals)

Experimental group

Description:

Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1

Treatment:

Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

Group 4: 65 years of age and older

Experimental group

Description:

Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1

Treatment:

Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)