FDA Approves Updated COVID-19 Shots from Pfizer, Moderna, Novavax with New Restrictions

The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax for the 2025–2026 season, but these are now only approved for specific risk groups instead of the general population1 2 3 4.

Vaccines are approved for all adults 65 and older, and for younger patients (ages 5–64 for Pfizer, 6 months–64 for Moderna, 12–64 for Novavax) only if they have at least one underlying health condition that puts them at high risk, such as asthma, cancer, or obesity1 2 3 4.

Pfizer's updated vaccine is no longer authorized for children under 5; Moderna remains the only option for children as young as 6 months, but only for those with a qualifying underlying condition1 4.

The new vaccines specifically target the LP.8.1 sublineage, an offshoot of the JN.1 variant, better matching currently circulating strains as advised by the FDA3 5.

Emergency use authorizations for broader groups have been rescinded, marking a significant shift from prior years when annual boosters were recommended for nearly all age groups2 4.

Access to the vaccines for those outside the restricted groups will depend on federal guidelines, insurance decisions, and consultation with healthcare providers, raising concerns about barriers to vaccination for some1 3 4.