India Pharma Outlook Team | Wednesday, 10 September 2025
Pfizer Inc. and BioNTech SE announced promising topline findings from a phase 3 study of their LP.8.1-adapted Comirnaty Covid-19 vaccine (2025-2026 Formula) that targets the SARS-CoV-2 evolution. The study involved adults aged 65 and older and adults aged 18-64 with at least one underlying risk factor for severe Covid-19.
As noted in the top line findings, initial data shows that there was a strong increase of neutralizing antibodies against the LP.8.1 sub-lineage that supports pre-clinical data, and was the basis of the recent FDA approval of the product.
Fourteen days after vaccination, neutralizing antibody levels for both age groups were more than four times the baseline levels. Furthermore, the vaccine safety profile was in line with prior versions and no new safety concerns were identified.
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There were a total of 100 subjects who were enrolled, all had received the KP.2-adapted Covid-19 vaccine at least six months prior to this trial, and none had been reinfected, or revaccinated after. The results showed that the updates can improve an immune boost with the higher risk populations ahead of the next vaccination season.
Over 5 billion Pfizer-BioNTech Covid-19 vaccine doses have been distributed worldwide and this new data adds to the large, strong real-world evidence and regulatory data. The LP.8.1-adapted vaccine has been developed with BioNTech proprietary mRNA technology and reinforces the companies' commitment to adaptation of protective responses to diseases as they change.
