The U.S. Food and Drug Administration has approved updated COVID-19 vaccines for the 2025-2026 season, but with restrictions limiting access primarily to older adults and individuals at high risk, amid rising case numbers and policy shifts under the new administration.
On Wednesday, August 27, 2025, the FDA granted approval to vaccines from Pfizer, Moderna, and Novavax, all updated to target the LP.8.1 variant of the coronavirus, which is currently the dominant strain. This decision marks a significant change from previous years, where vaccines were recommended for all Americans aged 6 months and older.
The approval is narrow in scope: Pfizer’s vaccine is now approved for adults 65 and older, as well as for those aged 5 to 64 with underlying health conditions that increase their risk of severe COVID-19. Moderna’s shot is approved for high-risk individuals from 6 months to 64 years, and Novavax’s vaccine for ages 12 to 64 at risk, with all three broadly available for seniors without restrictions.
Health and Human Services Secretary Robert F. Kennedy Jr. announced the decision on social media platform X, stating that the vaccines remain available for patients who choose them after consulting with their doctors. He emphasized his administration’s focus on ending vaccine mandates, ensuring availability for the vulnerable, demanding placebo-controlled trials, and concluding the emergency status.
This move follows Kennedy’s earlier changes to Centers for Disease Control and Prevention recommendations, which removed COVID-19 vaccines from the standard immunization schedule for healthy children and pregnant women, adopting a shared clinical decision-making model instead. These policy shifts have sparked controversy and criticism from medical organizations.
The American Academy of Pediatrics and the Infectious Diseases Society of America have voiced strong opposition, arguing that the narrowed approval contradicts scientific evidence and could severely limit access for vulnerable populations, such as young children who are at higher risk of hospitalization. The AAP released its own guidelines recommending vaccination for all children aged 6 through 23 months.
The approval could lead to out-of-pocket costs for some Americans, as insurers may not cover vaccines that are not broadly recommended by the CDC. This might exclude them from programs like Vaccines for Children, potentially costing over $140 per dose in the private sector.
Despite these restrictions, vaccine manufacturers are preparing to distribute the updated shots. Pfizer has begun shipping immediately, while Moderna expects availability in the coming days. This comes as the U.S. experiences a rise in COVID-19 cases, highlighting the ongoing need for protection.
The CDC’s reconstituted vaccine advisory panel, now under Kennedy’s influence, is expected to meet in September to make further recommendations, which will likely impact insurance coverage and public health strategies moving forward.