Pfizer Inc ((PFE)), Biontech Se Sponsored Adr ((BNTX)) announced an update on their ongoing clinical study.
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Pfizer Inc. and BioNTech SE have announced an update on their ongoing Phase 3 clinical study titled A Phase 3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19. The study aims to evaluate the safety and immune response of an updated COVID-19 vaccine targeting a circulating variant of SARS-CoV-2, specifically for adults at higher risk of severe disease.
The intervention being tested is a biological vaccine, BNT162b2 (Omi LP.8.1), designed to target a variant of the SARS-CoV-2 virus. Participants will receive a single 30 µg dose of this RNA-based vaccine, which is tailored for the 2025-2026 COVID-19 season.
This interventional study follows a parallel assignment model with no masking, focusing on prevention. It includes two experimental groups: individuals aged 18-64 at higher risk and those aged 65 and older, each receiving the vaccine at the first visit.
The study began on July 7, 2025, with the last update submitted on July 30, 2025. These dates mark the study’s initiation and the latest information available, respectively, indicating the study is actively recruiting participants.
The market implications of this study are significant for Pfizer and BioNTech, as successful results could enhance their positions in the COVID-19 vaccine market, potentially boosting stock performance and investor confidence. This development is crucial as companies continue to adapt to emerging variants and maintain competitiveness in the pharmaceutical industry.
The study is currently ongoing, with further details available on the ClinicalTrials portal.