COVID-19 vaccine for children and adults at risk of severe disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial evaluates updated BNT162b2 COVID-19 vaccines in two cohorts: participants aged 5 and above with at least one condition increasing risk for severe COVID-19, and older adults. Cohort 1 receives a single age-appropriate dose (30 mcg for 12+ or 10 mcg for 5-11) of the vaccine targeting the 2026/2027 strain, with both participants and investigators aware of the assigned dose. Cohort 2 compares different vaccination strategies through randomization. The study will monitor safety and immune response, with enrollment limited to medically stable individuals who have not recently had COVID-19 or recent vaccinations. Lead sponsor is BioNTech SE with Pfizer as collaborator, and multiple U.S. sites participate in the trial.

Why it matters

Who can join: the full rules

Key Inclusion criteria:

* Participants 5 years of age or older.
* Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.

Key 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.
* 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 3 months (90 days) prior to study enrolment.

Refer to the study contact for further eligibility details.

Where it's running

• C & R Research Servcies USA, Inc.
  Homestead, Florida, United States Recruiting
• Indago Research & Health Center, Inc
  Miami Lakes, Florida, United States Recruiting
• AGILE Clinical Research Trials, LLC
  Atlanta, Georgia, United States Recruiting
• East-West Medical Research Institute
  Honolulu, Hawaii, United States Recruiting
• Kentucky Pediatric /Adult Research
  Bardstown, Kentucky, United States Recruiting
• Dayton Clinical Research
  Dayton, Ohio, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Updated COVID-19 vaccine safety in healthy adults 18–64

  This study tests an updated COVID-19 vaccine and a booster vaccine in healthy adults to see how safe they are and how the body responds.

  Recruiting at 5 sites Phase 4 BioNTech SE · Walnut Creek, California and 4 other locations · NCT07730450

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.