Pfizer and BioNTech secured FDA approval for their updated 2026-2027 COVID-19 vaccine. The new formula targets the XFG variant to align with current viral strains.
The approval covers adults aged 65 and older. It also includes individuals aged 5 through 64 with high-risk underlying conditions.
Regulators based the decision on a review of clinical, non-clinical, and real-world data.
Pfizer began immediate shipping to U.S. pharmacies, hospitals, and clinics. The rollout aims to provide access before the fall and winter infection surge.