FDA Limits COVID-19 Vaccine Access For Healthy Children And Adults - Here's What You Need To Know

2025-08-28 03:34:48

(MENAFN- Live Mint) The US Food and Drug Administration on Wednesday (August 27) approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax but narrowed their recommended use, particularly for younger adults and children. The changes mark a significant shift from previous guidance, which recommended annual shots for all Americans six months and older.

“The American people demanded science, safety, and common sense. This framework delivers all three,” Kenned wrote on social media.

Restrictions for younger populations

The new guidance allows all seniors to receive the updated vaccines, but younger adults and children may only be vaccinated if they have at least one high-risk health condition, such as asthma or obesity. Pfizer's vaccine will no longer be available for children under five, as the FDA revoked its emergency use authorization for that age group. Moderna's Spikevax remains available for children as young as six months, but only for those with serious health conditions. Novavax's protein-based vaccine is approved for individuals 12 and older under similar restrictions.

Targeting new virus variants

The updated vaccines are designed to target the LP.8.1 coronavirus subtype, a recently dominant version of the virus. Pfizer and Moderna expect doses to be available within days, while Novavax anticipates distribution in early fall.

Access and Coverage Challenges

The risk-based approach may create barriers for millions of Americans. Patients under 65 may need to provide documentation of a qualifying health condition, a process complicated by the fact that most vaccinations are administered by pharmacists, who often cannot collect such information. Insurance coverage may also vary, potentially requiring out-of-pocket costs of $150 or more for those not considered high-risk.

Debate among medical experts

Some groups, including the American Academy of Pediatrics, have criticized the new limits, warning that healthy children may be blocked from receiving vaccines that could protect them. Health Secretary Robert F. Kennedy Jr. emphasized that vaccines will still be“available for all patients who choose them after consulting with their doctors.”

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