The U.S. Food and Drug Administration on 27 Aug 2025 cleared updated Covid-19 vaccines from Pfizer/BioNTech, Moderna and Novavax that target the LP.8.1 strain of the prevailing JN.1 variant. At the same time, the agency revoked all remaining emergency use authorizations, marking the most sweeping overhaul of federal Covid vaccine policy since the shots were first rolled out. Under the new labels the vaccines are fully approved for adults aged 65 and older, but access for younger people is restricted to those with at least one condition that increases the risk of severe Covid-19. Pfizer’s Comirnaty is authorised for people aged 5-64 who meet the risk criteria; Moderna’s Spikevax covers those aged 6 months-64; and Novavax’s protein-based Nuvaxovid is limited to ages 12-64. The decision removes Pfizer’s previous emergency authorisation for children under five. Health and Human Services Secretary Robert F. Kennedy Jr. said the move replaces blanket recommendations with a “science-based, common-sense” framework. Medical societies, including the American Academy of Pediatrics, warned the limits could complicate insurance coverage and leave healthy children and adults seeking off-label access to the shots. Pfizer and Moderna began shipping their updated doses within hours of the ruling, while Novavax expects distribution in early autumn. The FDA also directed Pfizer to conduct a large outcomes study and research into potential long-term post-vaccine syndromes. Shares of all three manufacturers rose briefly after the announcement before surrendering gains. The regulatory shift coincided with fresh turbulence at the Centers for Disease Control and Prevention: the Department of Health and Human Services said Director Susan Monarez “is no longer director”, a claim her lawyers dispute, and several senior officials resigned. The leadership uncertainty underscored the broader realignment of U.S. vaccine strategy under the Trump administration.