New COVID shot tested in vulnerable kids

NCT ID NCT07222384

Ongoing ⭐️ VACCINE ⭐️ Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests an updated COVID-19 vaccine (BNT162b2, 2025/2026 formulation) in 343 children aged 5 to 11 who have medical conditions that put them at high risk for severe COVID-19. All participants receive one dose and are monitored for about 6 months to check safety and immune response. The goal is to see if the updated vaccine is safe and works well in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: BNT162b2 (2025/2026 formulation) COVID-19 vaccine
What this could lead to: If successful, this could show that an updated COVID-19 vaccine is safe and effective for high-risk children, helping protect them from severe illness.
What could go wrong: This is a relatively small Phase 3 trial (343 participants) and focuses on immune response and safety, not direct prevention of infection. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease Coronaviridae Infections Infections lung disorder respiratory system disorder respiratory tract infectious disorder viral infectious disease COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 SARS-COV-2 INFECTION

Contacts and locations

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Locations

ACRC Trials

Plano, Texas, 75024, United States
AMR Clinical

Oak Brook, Illinois, 60523, United States
AMR Clinical

Layton, Utah, 84041, United States
Bio-Medical Research LLC

Miami, Florida, 33144, United States
C & R Research USA

Homestead, Florida, 33030, United States
California Research Foundation

San Diego, California, 92123, United States
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States
Clinical Research Institute

Minneapolis, Minnesota, 55402, United States
Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States
Clinical Research Puerto Rico

Guayama, 00784, Puerto Rico
Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States
DM Clinical Research- Cyfair

Houston, Texas, 77065, United States
Dayton Clinical Research

Dayton, Ohio, 45409, United States
Florida Pharmaceutical Research and Associates

Miami, Florida, 33143, United States
GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States
Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States
J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States
Javara - Privia Medical Group North Texas - Stephenville

Stephenville, Texas, 76401, United States
Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States
Medical Research Partners

Ammon, Idaho, 83406, United States
Michigan Center of Medical Research (MICHMER)

Bingham Farms, Michigan, 48025, United States
Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico
Senders Pediatrics

South Euclid, Ohio, 44121, United States
Stanford University Medical Center CTRU - 800 Welch Road

Palo Alto, California, 94304, United States
Sun Research Institute

San Antonio, Texas, 78215, United States
Tekton Research, LLC.

Richmond, Virginia, 23233, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States

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