Pfizer and BioNTech Announce FDA Approval for New Monovalent mRNA COVID-19 Vaccine, COMIRNATY LP.8.1

Aug 27 , 2025

NEW YORK & MAINZ, Germany, August 28, 2025 – Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application for a new monovalent mRNA COVID-19 vaccine, COMIRNATY LP.8.1. The vaccine is authorized for adults aged 65 and older and for individuals aged 5 to 64 with underlying health conditions that increase their risk of severe COVID-19 outcomes.

The approval of the LP.8.1-adapted vaccine is a key step in addressing the evolving SARS-CoV-2 virus. The FDA’s decision was based on clinical and preclinical data that showed the updated mRNA vaccine provides an enhanced immune response against several circulating variants, including XFG and NB.1.8.1, compared to earlier versions. The FDA had previously identified LP.8.1 as the preferred sublineage for the 2025 fall season.

The companies stated that shipments of the new vaccine will begin immediately and are expected to be available in U.S. pharmacies, hospitals, and clinics within days. The vaccine leverages BioNTech’s established mRNA technology, which has been used to distribute over 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine globally.

Source:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval

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