Pfizer (PFE) and BioNTech (BNTX) announced topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-microgram dose of the LP.8.1-adapted monovalent COMIRNATY 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. These clinical findings reinforce pre-clinical data that supported the recent U.S. Food and Drug Administration approval of the LP.8.1-adapted COVID-19 vaccine, which demonstrated improved immune responses against multiple circulating SARS-CoV-2 sublineages. A total of 100 participants were enrolled in the open-label Phase 3 trial cohort, 50 adults aged 65 and older and 50 adults aged 18-64 with at least one underlying risk condition for severe COVID-19. Prior to receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula, all participants had received the KP.2-adapted COVID-19 vaccine at least six months prior to enrollment and had not received any other COVID-19 vaccine or had COVID-19 disease since the KP.2 vaccination through enrollment in the study. Data from evaluable participants showed that the LP.8.1-adapted COVID-19 vaccine elicited a robust immune response against the LP.8.1 sublineage. 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. The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified. 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.
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