U.S. FDA Approves Latest Covid-19 Shots for Limited Populations Amid Surge

The U.S. Food and Drug Administration (FDA) has approved updated Covid-19 vaccines but limited their use to specific groups: adults aged 65 and older, and younger people at higher risk of severe illness.

“FDA has now issued marketing authorization for those at higher risk: Moderna (6 months and older), Pfizer (5 and older), and Novavax (12 and older),” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said in a post on X. “These vaccines are available for all patients who choose them after consulting with their doctors.”

The updated vaccines have been reformulated to target coronavirus strains circulating more recently.

Kennedy noted that he had promised “to keep vaccines available to people who want them, especially the vulnerable,” but the narrower authorization may limit access for many Americans who previously qualified.

Access could be particularly challenging for infants and young children, who remain especially vulnerable to Covid-19. Last respiratory virus season, there were 48 hospitalizations per 100,000 children under age 5 — nearly seven times the rate for older children and more than double the rate for adults under 50.

Kennedy also announced that the FDA has rescinded emergency use authorizations for earlier Covid-19 vaccines. As a result, Pfizer’s Comirnaty vaccine is no longer authorized for children under 5. Moderna’s Spikevax vaccine remains approved for children as young as 6 months, but only if they have underlying health conditions that put them at higher risk.

Novavax’s Covid-19 vaccine, the only protein-based, non-mRNA option available in the U.S. — is authorized for people 65 and older, as well as for those aged 12 and up with at least one high-risk condition.