FDA narrows COVID vaccines eligibility without clinician prescription

The Food and Drug Administration on Aug. 27 approved updated COVID-19 vaccines from Pfizer, Moderna and Novavax for the 2025–26 season but sharply narrowed who can receive them without a clinician’s prescription, setting off immediate confusion over availability, insurance coverage and where Americans can get shots as respiratory virus season approaches. Under the FDA labeling, people 65 and older are eligible, as are anyone six months and older who have at least one underlying condition that increases the risk of severe COVID-19; otherwise, physicians may prescribe the vaccine off label after a clinical discussion, officials said.

Manufacturers said doses would begin shipping immediately. Pfizer and Moderna said shipments were starting in the coming days and hospitals and pharmacies should begin to receive doses; Novavax expects distribution in early fall. Health and Human Services Secretary Robert F. Kennedy Jr. posted on X that the framework keeps vaccines available to those who want them while demanding additional study.

But the change has complicated access in practice. CVS, the nation’s largest pharmacy chain, said it was not offering COVID vaccines in 16 states and the...