BNT162b2 Vaccine for COVID-19
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.12345Why 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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 1 dose of the BNT162b2 (2025/2026 formulation) vaccine
Follow-up
Participants are monitored for safety and immunogenicity after receiving the vaccine
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?
1
Treatment groups
Experimental Treatment
BNT162b2 (2025/2026 formulation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
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
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-demonstratingPfizer 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 ...
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 ...
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/ ...
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– ...
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.
SAFETY DATA SHEET
Formulation; PF-07302048 containing PF-08152264 (BNT162b2); ... Containing PF-08152264 (BNT162b2);COVID-19 Vaccine Containing PF-08152264.
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 ...
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 ...
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