Home » Pfizer and BioNTech Report Strong Immune Response from LP.8.1-Adapted COVID-19 Vaccine
Pfizer and BioNTech have announced topline Phase 3 clinical trial data showing a robust immune response from their LP.8.1-adapted COMIRNATY® (COVID-19 Vaccine, mRNA) 2025–2026 Formula.The trial included 100 adults, with 50 participants aged 65 and older and 50 aged 18–64 with at least one underlying health condition linked to a higher risk of severe COVID-19. Fourteen days after vaccination, participants demonstrated at least a four-fold increase in LP.8.1-neutralising antibody levels compared with pre-vaccination results.The vaccine’s safety profile was consistent with previous studies, with no new safety concerns identified. Participants had previously received the KP.2-adapted vaccine at least six months earlier, with no COVID-19 infections or additional vaccinations reported during that time.These results reinforce pre-clinical evidence and support the recent approval by the U.S. Food and Drug Administration (FDA) of the 2025–2026 vaccine formula. Pfizer and BioNTech have submitted the new clinical findings to the FDA for review.Since launch, more than 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed worldwide, supported by extensive clinical and real-world data. The vaccines are based on BioNTech’s proprietary mRNA technology and developed jointly by both companies. BioNTech holds the marketing authorisation for COMIRNATY® and its adapted formulations in the U.S., EU, UK, and additional markets.
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