FDA approves updated COVID vaccines for adults 65 and older and higher-risk patients

WASHINGTON - The Food and Drug Administration approved updated COVID-19 vaccines for the 2026-27 season, allowing Moderna, Pfizer-BioNTech and Novavax-Sanofi to begin shipping doses to pharmacies and clinics, the companies said Thursday.

The shots are approved for adults 65 and older and for younger people who have underlying conditions that raise the risk of severe illness. Age cutoffs for those younger high-risk groups vary by product. Moderna's Spikevax covers high-risk patients from 6 months up, Pfizer-BioNTech's Comirnaty from age 5, and Novavax-Sanofi's protein shot from age 12, according to company notices covered by Reuters and other outlets.

An FDA advisory panel in May backed targeting the JN.1-lineage XFG variant for this season's monovalent formula. Manufacturers said they could produce updated doses in time for fall. Pfizer said shipping would begin immediately. Moderna and Sanofi-Novavax said doses would reach sites in the coming days depending on location.

Under Trump administration policy, federal guidance has moved away from a universal COVID shot recommendation toward a focus on older adults and people with risk factors, with patients encouraged to consult a clinician. Coverage rules and state pharmacy practices can still differ, which left some shoppers confused last season.

Conditions that raise severe-disease risk include asthma, heart, kidney, liver or lung disease, diabetes, obesity and pregnancy, according to CDC materials cited in coverage. Moderna CEO Stephane Bancel said COVID still drove substantial outpatient visits and hospitalizations last year and that updated vaccines help protect those at highest risk this respiratory season.

Pharmacies typically bundle COVID shots with flu clinics once inventory arrives. Patients who want both should call ahead, bring insurance cards and ask whether any state rules still require a prescription or attestation for younger high-risk adults. Last year's patchwork access left some stores oversupplied and others short in the first weeks of fall.