The FDA has approved Pfizer and BioNTech’s updated COVID-19 vaccine for adults 65 and older along with individuals ages 5-64 who are at increased risk of severe COVID-19.
The new formulation targets several SARS-CoV-2 sublineages, aligning with the FDA guidance to better match circulating strains expected during the 2025-2026 virus season, according to an Aug. 27 news release from Pfizer.
The approval is based on clinical and preclinical trial data, which found improved immune responses against multiple sublineages, including XFG and NB.1.8.1.
Shipping of the vaccine has started, with doses set to arrive at hospitals, pharmacies and clinics across the U.S. in the coming days, the release said.
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