Pfizer and BioNTech’s COMIRNATY® COVID-19 Vaccine Receives Approval for Older Adults and High-Risk Groups
Thursday, August 28, 2025
Pfizer and BioNTech have received approval from the U.S. Food and Drug Administration (FDA) for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY® LP.8.1.
The vaccine is authorised for adults aged 65 and older, as well as for individuals aged 5 to 64 who have underlying health conditions that increase the risk of severe COVID-19.
The approval is supported by clinical trial results and real-world evidence, including data for children aged 5 to 11. Pre-clinical studies showed that the updated vaccine produces stronger immune responses against several circulating SARS-CoV-2 sublineages, such as XFG, NB.1.8.1 and other emerging variants, compared with previous versions.
The LP.8.1 strain was chosen based on FDA guidance as the preferred sublineage for monovalent vaccines in the United States starting from autumn 2025. Distribution of the updated vaccine will begin immediately, with availability expected in pharmacies, hospitals and clinics in the coming days.
To date, Pfizer and BioNTech have distributed about 5 billion doses of their COVID-19 vaccines worldwide.
The vaccines, built on BioNTech’s mRNA technology, continue to demonstrate a strong safety and efficacy profile through extensive clinical trials and real-world use.
Source: pfizer.com
