FDA Clears Updated COVID Shots for Fall
FDA Clears Updated COVID Shots for Fall
The News
The Food and Drug Administration has approved updated COVID-19 vaccines for the 2026-27 season from Moderna, Pfizer-BioNTech and Novavax-Sanofi, the companies announced Thursday.
The updated shots are built to target XFG, a subvariant of the JN.1 coronavirus strain, after the FDA's independent vaccine advisers voted in May to make XFG this year's target.
Unlike the pandemic years, the shots are not cleared for everyone. Pfizer and BioNTech said their Comirnaty vaccine is approved for adults 65 and older and for people ages 5 through 64 with at least one underlying condition that raises their risk of severe COVID-19, according to The National Desk.
Moderna said the FDA approved updated versions of both its vaccines: Spikevax for people 6 months through 64 with a high-risk condition and for all adults 65 and up, and mNEXSPIKE for adults 65 and older plus high-risk people ages 12 through 64.
Timeline
Eight of the nine members of the FDA's vaccine advisory committee voted in favor of targeting the XFG variant for the 2026-27 campaign, Reuters reported. For the 2025-26 season, the FDA had recommended shots target LP.8.1, another JN.1 subvariant.
XFG.1.1 was the predominant coronavirus strain causing illness in the United States, according to CDC genomic surveillance cited by CNN.
CDC data put the COVID test positivity rate approaching 5% for the first time since early February, with numbers climbing in every state, CNN reported.
Pfizer-BioNTech, Moderna and Novavax-Sanofi announced FDA approval of their updated formulas. Reuters reported the sign-off covers all four COVID shots previously approved for use in the U.S. — Moderna's mNEXSPIKE and Spikevax, Pfizer-BioNTech's Comirnaty, and Novavax-Sanofi's protein-based vaccine.
Reactions
Pfizer and BioNTech said their updated vaccine would begin shipping immediately and should reach pharmacies, hospitals and clinics within days. Moderna said its updated shots are expected to be available soon.
The companies said the vaccines carry warnings about rare cases of myocarditis and pericarditis after mRNA vaccination, which have occurred most often in males ages 12 through 24.
The CDC has not yet issued an official recommendation for this year's shots, CNN reported, though most medical organizations recommend getting one and insurers have indicated they will keep covering it.
What's Next
Experts told CNN the vaccines should start hitting pharmacies and doctors' offices in September. A formal CDC recommendation is still outstanding.
Under the Trump administration, the federal government moved away from a universal COVID vaccine recommendation to a narrower one, in which everyone 6 months and older is advised to consult a health care provider before getting the shot.
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Conditions that can raise the risk of severe illness include asthma; heart, kidney, liver or lung disease; diabetes; obesity; and pregnancy, according to the CDC.
Novavax-Sanofi's shot is the only protein-based COVID vaccine available in the U.S. and takes longer to manufacture than the mRNA vaccines, Reuters reported. The CDC's COVID dashboard currently lists new strain data as unavailable because of low sequencing submissions.
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