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The U.S. Food and Drug Administration (FDA) has approved a fresh round of COVID-19 vaccines for the 2025–2026 season, this time with stricter rules on who can get them.

The updated Pfizer-BioNTech vaccine is cleared for adults aged 65 and older, as well as for individuals between 5 and 64 who have at least one health condition that puts them at high risk for severe COVID-19.

Moderna’s latest formulation will be available to high-risk groups 6 months and older, while Novavax has been approved for those aged 12 and above.


According to a joint statement, the Pfizer-BioNTech shot has been designed to target LP.8.1—a sublineage of the JN.1 variant—in line with FDA guidance to better match the virus strains currently in circulation.






“These vaccines are available for all patients who choose them after consulting with their doctors,” Health and Human Services Secretary Robert F. Kennedy Jr. shared on X. “The American people demanded science, safety, and common sense. This framework delivers all three.”



What changed — who qualifies and what’s no longer available



Under the new approach, eligibility is narrowly focused on older adults and people with specified medical risks. The FDA also revoked Emergency Use Authorizations for vaccines in younger children, which would make the Pfizer shot unavailable for children younger than 5.



Proponents of the limits argue younger, healthy people are far less likely to suffer severe illness and point to falling uptake — about 23 percent among all adults and 13 percent of people younger than 18 — as part of the rationale.




The agency asked manufacturers to conduct additional studies, including a new, required trial to examine “post-Covid-19 vaccination syndrome” in patients — a condition noted in at least one small preliminary report and still under debate.



This would mark the first fall/winter season that COVID shots were not widely recommended to most people and children. Kennedy has also drawn scrutiny for cancelling $500 million in grants to study flu and COVID vaccines, a move critics say could set back development of new therapies and leave the nation reliant on older approaches.