Overview
- Regulators approved updated vaccines for adults 65 and older and for younger people with at least one qualifying medical condition, curtailing access for healthy children and most younger adults.
- Authorizations specify manufacturer and age ranges tied to high-risk status: Moderna for ages 6 months and up, Pfizer for 5 and up, and Novavax for 12 and up.
- The FDA ended emergency use pathways, and it revoked Pfizer’s authorization for children under 5, leaving Moderna as the only mRNA option for the youngest children but limited to those with serious health problems.
- Health Secretary Robert F. Kennedy Jr. said the actions fulfill pledges to scale back mass vaccination, keep shots available for the vulnerable, require placebo-controlled trials, and declare the emergency over.
- Medical groups including the American Academy of Pediatrics criticized the limits as harmful to families seeking pediatric vaccination, while insurers, pharmacies and a forthcoming CDC advisory review will shape real-world access as cases rise and a “stratus” strain circulates in parts of the West and South.