FDA Approves Four Updated COVID Shots Targeting XFG Variant

The FDA approved four updated COVID-19 vaccines for the 2026-2027 season targeting the SARS-C0V-2 variant that dominated last season.

Moderna, Pfizer and BioNTech, and Novavax, Sanofi, and Takeda announced Thursday that their COVID shots formulated against the XFG variant for the upcoming season had earned FDA approval.

Moderna’s mRNA vaccine (Spikevax) is approved for everyone ages 65 years or older, as well as people ages 6 months to 64 years who have at least one underlying condition that puts them at high risk for severe COVID. A second Moderna mRNA vaccine (mNexspike) is approved for everyone ages 65 or older, as well as those ages 12 to 64 with at least one underlying condition that boosts their risk of severe COVID.

Pfizer and BioNTech’s mRNA vaccine (Comirnaty) is approved for everyone ages 65 or older, and those ages 5 to 64 with at least one underlying condition that increases severe COVID risk. Novavax and Sanofi’s protein-based non-mRNA vaccine (Nuvaxovid) earned FDA approval for everyone ages 65 or older and those ages 12 to 64 with at least one underlying condition that increases their risk of severe COVID.

Moderna said its updated vaccines would be available “in the coming days.” Pfizer and BioNTech will begin shipping vaccines immediately.

XFG was the dominant SARS-CoV-2 strain in the 2025-2026 COVID season, according to the CDC. In May, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 8 to 0, with one abstention, in favor of a monovalent XFG vaccine for COVID shots for the 2026-2027 season.

The CDC has not yet weighed in on seasonal COVID shot recommendations. The agency’s controversially revamped Advisory Committee on Immunization Practices (ACIP) remains in legal limbo and didn’t hold its regular March or June meetings this year.

Before ACIP’s suspension, the CDC, under HHS Secretary Robert F. Kennedy Jr., moved away from universally recommending COVID shots for everyone, including healthy children and pregnant women. For the 2025-2026 season, the CDC recommended COVID vaccination for people ages 6 months or older using “individual-based decision-making.“

Despite the CDC’s silence this year, the Infectious Diseases Society of America, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have issued guidance on fall respiratory virus shots, including COVID vaccines. Insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027.

The American College of Physicians recommends COVID vaccination for everyone ages 65 or older and for those ages 18 to 64 who are at increased risk of severe COVID. Adults ages 18 to 64 who aren’t at greater risk of severe COVID may consider getting a shot, the guidance states.

The American Academy of Pediatrics (AAP) will unveil its updated 2026-2027 COVID vaccination recommendations in September. Last season, the AAP recommended COVID vaccination for all infants and children ages 6 to 23 months who don’t have contraindications. The AAP also recommended shots in children ages 2 to 18 years at high risk of COVID, those living in long-term care facilities, those who haven’t been vaccinated before for COVID, and those with household contacts at high risk for severe COVID.