FDA Approves Updated COVID-19 Booster Shots

Female doctor filling a syringe with the Covid-19 vaccine.

(August, 2025) The U.S. Food and Drug Administration on Aug. 27, 2025, approved newly updated COVID-19 booster shots from Pfizer, Moderna and Novavax for the upcoming fall and winter season, but narrowed access for many Americans. The vaccines are now authorized fully for seniors, while younger adults and children must have at least one underlying health condition, such as asthma or obesity, to be eligible.

In a notable shift, the FDA revoked the emergency use authorization for Pfizer’s vaccine in children under 5, effectively making Moderna the only mRNA option for that age group, though only for those with serious health risks. Novavax’s protein-based vaccine is approved only for individuals 12 and older under the same risk-based criteria.

The new vaccines target recently circulating coronavirus variants and are expected to begin shipping immediately. However, public access may be delayed by days or weeks, depending on guidance from insurers, pharmacies, state officials and a reconfigured CDC advisory panel.

Health and Human Services Secretary Robert F. Kennedy Jr. defended the approach, stating that the updated framework delivers “science, safety, and common sense,” at the same time, asserting vaccines remain available to those who consult with their doctors.

Public health experts warn the narrowed eligibility could hamper vaccine uptake and sow confusion among patients, providers and pharmacists, especially given that many states limit pharmacist administration to vaccines recommended by federal panels.

Earlier recommendations had encouraged annual COVID-19 shots for all individuals six months and older. This marks the first fall-winter season without such a broad federal endorsement.

Although eligibility rules may be shifting, your pharmacy continues to be a trusted resource for clear answers and convenient access to vaccines. That is why AAP wants to keep your shelves stocked.

AAP negotiates with leading vaccine providers to bring Members exclusive pricing for their immunization programs. If you are an AAP Member, log in to the website and check out AAP’s Vaccine Program Resources under the Preferred Partners tab. And for tips on helping parents understand the need to vaccinate children, click here.