FDA says healthy people can still get COVID-19 vaccine but access might be complicated

FDA limited updated COVID-19 vaccine authorization to seniors and younger people with high-risk health conditions rather than approving the shots for everyone. Federal officials say vaccines remain available to all adults if they choose, but healthy people under 65 and children without qualifying conditions must obtain vaccines via off-label prescriptions. Off-label access requires provider consultations, creates insurance coverage uncertainty and depends on finding willing pharmacies. Those requirements replace straightforward pharmacy access and can materially reduce practical accessibility, potentially limiting uptake among many Americans who are technically still eligible to receive the vaccine.

On Wednesday, the US Food and Drug Administration approved updated COVID-19 vaccines specifically for seniors and younger people who have health conditions that put them at higher risk from COVID-19 - a much more limited approach than earlier approvals that greenlit the shots for everyone ages 6 months and older.

FDA Commissioner Dr. Marty Makary said in a social media post on Thursday that "100% of adults in this country can still get the vaccine if they choose. We are not limiting availability to anyone." White House press secretary Karoline Leavitt also said Thursday that "the FDA decision does not affect the availability of COVID vaccines for Americans who want them. We believe in individual choice."

To get an updated COVID-19 vaccine for the upcoming respiratory virus season, healthy children and adults younger than 65 will need to get it prescribed "off-label" - the practice of using a medical product outside of the terms for which the FDA has explicitly approved it. This theoretically makes vaccines available but "ignores the practical barriers the policy created," said Dr. Jake Scott, an infectious disease specialist with Stanford Health. "Technical availability and practical accessibility are very different things," he said. "The administration replaced straightforward pharmacy access with a system requiring provider consultations, navigating insurance uncertainty and finding willing pharmacies."

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