The U.S. Food and Drug Administration (FDA) has authorized updated COVID-19 vaccines from Pfizer, Moderna, and Novavax, but restricted their use. While seniors remain eligible for all three vaccines, younger adults and children can now only receive shots if they have certain health conditions.
The decision removes vaccine access for healthy children under 5 years old, as Pfizer’s shot previously covered this age group. Moderna’s vaccine is now limited to children with health conditions, and Novavax is not authorized for children under 12.
Pfizer stated the restriction is “not related to the safety and efficacy” of its vaccine, which continues to demonstrate a favorable profile. The American Academy of Pediatrics (AAP) called the FDA’s move “deeply troubling,” warning it increases risks for infants and toddlers during respiratory virus season.
Cost is another barrier: without federal authorization, most insurers will not cover vaccination for healthy children, leaving families to pay around $200 per dose. However, some insurers, including Kaiser Permanente and Blue Shield of California, have pledged to continue full coverage across all age groups.
The authorization decision has also deepened confusion. For the first time in 30 years, AAP vaccine guidance differs from U.S. government advice. The AAP strongly recommends shots for children aged 6 months to 2 years, while the CDC — under Health Secretary Robert F. Kennedy Jr. — does not recommend vaccination for healthy children of any age, instead leaving the choice to parents and physicians.
The updated vaccines target the LP.8.1 strain, which has circulated widely this year. However, the XFG variant, nicknamed “Stratus,” is now predominant in the U.S. While symptoms remain similar to past infections, doctors report sore throats and hoarseness are more common. Experts emphasize that these variants are not more severe but continue to spread quickly as the virus evolves.