BNT162b2 Vaccine for COVID-19

Not yet recruiting at 3 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: BioNTech SE

Disqualifiers: Recent COVID-19, Myocarditis, MIS-C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an updated COVID-19 vaccine, BNT162b2 (2025/2026 formulation), to assess its safety and effectiveness in children. The study examines a new vaccine version for the 2025-2026 COVID-19 season. It seeks children aged 5 to 11 with stable health conditions that could increase their risk from COVID-19. Participants will receive one vaccine shot and visit the study site twice over six months. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially life-saving vaccine.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to contact the study team for more details.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the BNT162b2 (2025/2026 version) COVID-19 vaccine generates a strong immune response. Previous studies have thoroughly evaluated its safety and effectiveness. For this new version, safety data indicate it is well-tolerated, with most side effects being mild, such as a sore arm or fatigue, similar to other vaccines.

The FDA has already approved the vaccine for other COVID-19 strains, suggesting it is generally safe, with little risk of serious problems. However, it is normal for any vaccine to have some side effects, which are usually minor.

This study involves children aged 5 to 11 with health conditions that increase their risk from COVID-19. The goal is to ensure the vaccine is safe and effective for this group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The BNT162b2 vaccine (2025/2026 formulation) is unique because it is specifically designed for higher-risk children aged 5 to 11. Unlike earlier versions, this formulation may offer enhanced protection tailored for younger age groups who are at greater risk. Researchers are excited because it builds on the success of previous COVID-19 vaccines while potentially offering improved safety and efficacy for vulnerable children. This could be a game-changer in protecting this specific age group more effectively against COVID-19.

What evidence suggests that the BNT162b2 (2025/2026 formulation) vaccine might be an effective treatment for COVID-19?

Research shows that the BNT162b2 vaccine, including its updated 2025/2026 version, creates a strong defense against COVID-19. Earlier data confirm that this version effectively targets the COVID-19 strains expected in the 2025-2026 season. Studies have found it to be safe and effective, particularly in preventing severe illness. In this trial, children aged 5 to 11 at higher health risks will receive this vaccine, which could significantly reduce the chances of severe COVID-19 cases. The success of earlier versions supports the belief that it will continue to perform well. ^{1 3 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for children aged 5-11 with conditions that increase their risk of severe COVID-19. They must be medically stable to participate. The study involves two visits over six months and all participants will receive a dose of the updated BNT162b2 vaccine.

Inclusion Criteria

I am between 5 and 11 years old.

My child has a condition that makes COVID-19 riskier for them.

Exclusion Criteria

Children who have received a 2025-2026 seasonal COVID-19 vaccination

My child had COVID-19 in the last 5 months.

My child has been vaccinated against COVID-19 in the last 5 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 dose of the BNT162b2 (2025/2026 formulation) vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after receiving the vaccine

6 months

At least 2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BNT162b2 (2025/2026 formulation)

Trial Overview The trial tests the safety, tolerability, and immune response generated by an updated version of the BNT162b2 vaccine, tailored for strains expected in the 2025/2026 viral season. Each child receives one shot in their arm muscle.

How Is the Trial Designed?

Group I: 5-11 Years (Higher-Risk Individuals) Experimental Treatment 1 Intervention

BNT162b2 (2025/2026 formulation)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating

Pfizer and BioNTech Announce Topline Data ... Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula · NEW ...

2. pfizer.com pfizer.com/news/announcements/pfizer-reaffirms-safety-and-efficacy-covid-19-vaccines

Pfizer Reaffirms Safety and Efficacy of COVID-19 Vaccines 2024-2025 BNT162b2 COVID-19 vaccine effectiveness in non-immunocompromised adults: mid-season estimates from vaccine registries in two ...

3. fda.gov fda.gov/media/186597/download

Pfizer/BioNTech- 2025-2026 COVID Vaccine Effectiveness (VE) Estimates are compared to no receipt of any 2024–2025 Covid-19 vaccine. Source: GISAID - gisaid.org; data accessed/ ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2510226

Association of 2024–2025 Covid-19 Vaccine with ... In the Covid-vaccine group, 105,040 (64.0%) received the 2024–2025 formula of mRNA-1273 vaccine (Moderna), 57,941 (35.3%) received the 2024– ...

5. cdc.gov cdc.gov/acip/grade/covid-19-pfizer-biontech-vaccine.html

Pfizer-BioNTech COVID-19 Vaccine | ACIP A systematic review of evidence on the benefits and harms of a two-dose regimen of Pfizer-BioNTech COVID-19 vaccine among persons aged ≥16 years was conducted.

6. medicomart.com medicomart.com/images/document/Comirnaty%202025-2026%20Safety%20Data%20Sheet.pdf

SAFETY DATA SHEET Formulation; PF-07302048 containing PF-08152264 (BNT162b2); ... Containing PF-08152264 (BNT162b2);COVID-19 Vaccine Containing PF-08152264.

7. comirnatyhcp.pfizerpro.com comirnatyhcp.pfizerpro.com/

COMIRNATY® (COVID-19 Vaccine, mRNA) Official HCP ... Info on 2025-2026 formula of COMIRNATY for people 65 & older and 5-64 years with at least 1 underlying condition that puts them at high risk for severe ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07222384

NCT07222384 | A Study to Learn About BNT162b2 (LP.8.1 ... The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 ...