RNA-Based Vaccine for COVID-19
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new version of a COVID-19 vaccine to evaluate its safety and effectiveness against a current virus variant. Participants will receive one shot of the BNT162b2 (Omi LP.8.1) vaccine, which targets a specific COVID-19 strain expected for the 2025-2026 season. The trial is open to individuals 65 and older, as well as adults aged 18 to 64 at higher risk for severe COVID-19, such as those with asthma or diabetes. Participants must have received a COVID-19 vaccine that included Omicron KP.2 more than six months ago. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking vaccine.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study contact or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the BNT162b2 vaccine, targeting the LP.8.1 variant of COVID-19, is generally safe. Most side effects are mild to moderate, such as temporary arm pain or tiredness, while serious side effects remain rare. The FDA approved this version of the vaccine, indicating a strong safety record. Designed to match current virus strains, it may enhance the immune response, offering hope for better protection and safety.12345
Why do researchers think this study treatment might be promising?
Unlike the standard COVID-19 vaccines, which often target the original virus strain, BNT162b2 (Omi LP.8.1) specifically targets the Omicron variant. This RNA-based vaccine is unique because it uses a modified version of the mRNA technology that allows it to adapt quickly to new virus mutations, potentially offering broader protection against evolving strains. Researchers are excited about this treatment because it could enhance immunity for higher-risk groups, such as those aged 18–64 with underlying conditions and individuals 65 and older, providing them with more robust defense against severe COVID-19 outcomes.
What evidence suggests that this RNA-based vaccine is effective for COVID-19?
Research shows that the BNT162b2 (Omi LP.8.1) vaccine, administered to participants in this trial, generates a strong immune response against COVID-19. Studies have found that this vaccine, updated for the 2025-2026 season, effectively targets both current and new variants. Tests conducted in labs before human trials demonstrated its superiority over earlier versions. Data also indicate that similar mRNA vaccines have successfully prevented severe COVID-19 cases. This vaccine builds on the success of previously approved versions and shows promise in reducing severe cases.56789
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 adults aged 18-64 at high risk of severe COVID-19 and those over 65. Participants will receive a shot of the BNT162b2 (Omi LP.8.1) vaccine, designed for the variant expected in the 2025-2026 season.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 1 shot of the BNT162b2 (Omi LP.8.1) 30 µg RNA-based vaccine
Follow-up
Participants are monitored for safety, tolerability, and immunogenicity after receiving the vaccine
What Are the Treatments Tested in This Trial?
Interventions
- BNT162b2 (Omi LP.8.1)
Trial Overview
The study tests safety, tolerability, and immune response to an RNA-based COVID-19 vaccine targeting a new variant. Participants get one dose and are monitored over six months with at least four visits to the clinic.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
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.
Pfizer/BioNTech- 2025-2026 COVID
Early Effectiveness of the BNT162b2 KP.2 Vaccine against ... • LP.8.1 vaccine confers improved immune response, in preclinical models,.
NCT07069309 | A Study to Learn About COVID-19 RNA ...
All participants in this study will receive 1 shot to their arm of a BNT162b2 (Omi LP. 8.1) 30 µg RNA-based vaccine which targets a circulating variant of SARS ...
4.
biontechse.gcs-web.com
biontechse.gcs-web.com/news-releases/news-release-details/pfizer-and-biontech-receive-positive-chmp-opinion-lp81-adapted-0Pfizer and BioNTech Receive Positive CHMP Opinion for LP ...
Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sublineages ...
5.
thecardiologyadvisor.com
thecardiologyadvisor.com/news/real-world-data-support-omicron-adapted-covid19-mrna-vaccines/Real-World Data Highlight Effectiveness of XBB.1.5- ...
Both BNT16b2 and mRNA-1273 XBB.1.5-adapted mRNA vaccines were effective against severe COVID-19 outcomes and conferred similar protection.
SAFETY DATA SHEET
Pfizer-BioNTech Covid-19 vaccine Tris-Sucrose Omicron LP.8.1 Variant ... Containing PF-08152264 (BNT162b2);COVID-19 Vaccine Containing PF-08152264.
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 ...
8.
pfizer.com
pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approvalPfizer and BioNTech's COMIRNATY® Receives U.S. FDA ...
The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match ...
Clinical Review Memo, August 27, 2025 - COMIRNATY
2026 Formula), preferentially using the LP.8.1 strain (COVID-19 Vaccines (2025-2026 Formula) ... The safety data from this study suggest that the ...
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