Pfizer reports strong phase 3 clinical data for 2025-26 COVID vaccine

September 10, 2025

"...Pfizer and BioNTech reported phase 3 clinical trial data for their updated COVID vaccine, Comirnaty. That vaccine is authorized for use by the Food and Drug Administration (FDA) for seniors 65 and older and for younger adults with at least one underlying health condition.  The data show at least a fourfold increase in neutralizing antibodies, reinforcing preclinical data, and Pfizer has submitted these data to the FDA.

4-fold increase in neutralizing antibodies 

The trial included 50 adults ages 65 and older and 50 adults ages 18 to 64 with at least one underlying health condition. All received the LP.8.1-adapted COVID-19 vaccine 2025-26 formula, and had previously received the KP.2-adapted COVID-19 vaccine at least 6 months prior to enrollment.

"In both age groups, 14 days following vaccination, LP.8.1-neutralizing antibody titers exceeded pre-vaccination levels, on average, by at least 4-fold," Pfizer said in a press release. "The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified."

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https://www.cidrap.umn.edu/covid-19/pfizer-reports-strong-phase-3-clinical-data-2025-26-covid-vaccine

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

September 08, 2025

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"The favorable neutralizing antibody responses and consistent safety profile of the LP.8.1-adapted vaccine for individuals with higher risk and who had been previously exposed to SARS-CoV-2 provide early information for prescribers for this year’s vaccination period. This study was conducted to provide additional information about immunological effects of the vaccine and is not intended to replace the post marketing commitments requested by the FDA.

To date, 5 billion doses have been distributed globally of the Pfizer-BioNTech COVID-19 vaccine, which continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as by clinical, non-clinical, pharmacovigilance, and manufacturing data."

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https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating