Pfizer and BioNTech’s COMIRNATY Gets FDA Approval for Seniors and High-Risk Individuals Ages 5-64

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application (sBLA) for the LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1). The approval covers adults aged 65 and older, as well as individuals ages 5 through 64 with at least one underlying condition that increases their risk for severe COVID-19.

The FDA’s decision is supported by extensive evidence demonstrating the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine. This includes clinical trial data previously supporting the vaccine’s use in children aged 5 to 11 years, alongside pre-clinical data showing that the LP.8.1-adapted vaccine generates stronger immune responses against multiple current SARS-CoV-2 sublineages—such as XFG and NB.1.8.1—compared to earlier vaccine adaptations.

The selection of the LP.8.1 sublineage for this vaccine follows FDA guidance recommending it as the preferred monovalent variant for the 2025 fall season in the U.S. Shipments of this updated vaccine have already begun and will soon be available nationwide at pharmacies, hospitals, and clinics.

Since its initial rollout, Pfizer and BioNTech have distributed 5 billion doses globally of their COVID-19 vaccine, which continues to maintain a strong safety and efficacy profile backed by real-world data and ongoing clinical and manufacturing oversight.

COMIRNATY vaccines utilize BioNTech’s proprietary mRNA technology and are jointly developed by the two companies. BioNTech holds marketing authorization for COMIRNATY and its adapted versions in the U.S., EU, UK, and other countries, as well as emergency use authorizations worldwide.