The U.S. Food and Drug Administration (FDA) has authorized new formulations of COVID-19 vaccines from Pfizer, Moderna, and Novavax, but with narrower eligibility rules that significantly change previous vaccination guidance.
Unlike earlier recommendations that encouraged annual boosters for nearly all Americans aged six months and older, the FDA’s new framework reserves broad access primarily for older adults.
Who Can Get the Shots
Under the revised guidelines, all seniors are cleared to receive the updated vaccines. However, adults under 65, adolescents, and children will only qualify if they have at least one high-risk medical condition such as obesity, asthma, or diabetes.
For children, the rules diverge by manufacturer. Pfizer’s vaccine will no longer be available for those under five after the FDA revoked its emergency authorization. Moderna’s Spikevax remains accessible to children as young as six months, but only for those with serious underlying health issues. Novavax’s protein-based shot is now cleared for individuals 12 and older under the same restrictions.
Targeting New Variants
The new doses are specifically designed to protect against LP.8.1, a coronavirus subtype that has recently become dominant in the U.S. Pfizer and Moderna expect shipments to begin within days, while Novavax plans to roll out its supply in early fall.
Access and Cost Concerns
The FDA’s risk-based approach may complicate access for many Americans. Patients under 65 could be asked to provide proof of qualifying conditions — a challenge since most vaccinations are handled by pharmacists, who may not be able to verify medical records. Insurance coverage is also uncertain, raising the possibility that some individuals may face out-of-pocket costs exceeding $150.
Mixed Reactions in the Medical Community
The new rules have sparked debate. The American Academy of Pediatrics criticized the restrictions, cautioning that otherwise healthy children could miss out on protection.
Health Secretary Robert F. Kennedy Jr. defended the policy, saying it “ensures vaccines remain available for those who need them most” while still allowing any patient to discuss vaccination options with their physician.
The FDA’s decision marks one of the most significant adjustments to U.S. COVID-19 vaccine policy since the shots first became available in late 2020.