Pfizer and BioNTech release topline data highlighting robust immune response with their LP.8.1-adapted COVID-19 vaccine formula

Pfizer announces their new topline results from a phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg 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.

In addition, 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.

Note that 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. COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies.

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BioNTech, covid vaccine, Pfizer, vaccine