FDA approves updated COVID-19 vaccines with new restrictions, potentially limiting access for healthy children

Healthy children may now only receive a COVID-19 vaccine ‘off-label’ – but in many states, pharmacists and other non-physicians may not be able to administer them that way.

By: Dr. David Higgins

Outlets: The Conversation University of Colorado Anschutz Medical Campus

Published: August 28, 2025

Words: 1,045

Last Updated: 2 months, 3 weeks ago

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Guidance around COVID-19 vaccines has once again shifted after the Food and Drug Administration on Aug. 27, 2025, approved updated shots for the fall season, but for a more limited group than in prior seasons.

These changes, announced on X by Secretary of Health and Human Services Robert F. Kennedy Jr., raise new questions about eligibility and availability of COVID-19 vaccines for children.

As a pediatrician and researcher who studies vaccine …

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