The new FDA approach is the culmination of a

Prasad said the FDA will ask all manufacturers to do new clinical trials in healthy people ages 50 to 64, randomly assigning them to get a vaccine or a placebo and tracking outcomes with special attention to severe disease, hospitalization or death. Companies might need to repeat that requirement for future vaccine approvals if there’s a large virus mutation rather than the past year’s incremental evolution. Companies are also free to test their vaccines for approval in younger adults and children, Prasad said, adding “this is a free country.”Since becoming the nation’s top health official in February, Kennedy has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, including Makary and Prasad. Under federal procedures, the FDA releases new guidance in draft form and allows the public to comment before finalizing its plans. The publication of Tuesday’s policy in a medical journal is highly unusual and could run afoul of federal procedures, according to FDA experts.

Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended only for people at increased risk.In June, an influential panel of advisers to the CDC is set to debate which vaccines should be recommended to which groups.The FDA’s announcement appears to usurp that advisory panel’s job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.WASHINGTON (AP) — Democrats and Republicans alike raised concerns on Wednesday about deep staffing cuts, funding freezes and far-reaching policy changes overseen by

A bipartisan group of lawmakers questioned Kennedy’s approach to the job, some saying that he has jeopardized vaccine uptake, cancer research and dental health in just a few short months.

In combative and at times highly personal rejoinders, Kennedy defended the TrumpSpecial “compassionate use” experiments teach doctors a lot but it will take rigorous studies to prove if xenotransplants really work. What happens with Pisano and Mass General’s kidney recipient will undoubtedly influence FDA’s decision to allow such trials. United Therapeutics said it hopes to begin one next year.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.PHILADELPHIA (AP) — Jazmin Evans had been waiting for a new kidney for four years when her hospital revealed shocking news: She should have been put on the transplant list in 2015 instead of 2019 — and a racially biased organ test was to blame.

As upsetting as that notification was, it also was part of an unprecedented move to mitigate the racial inequity. Evans is among more than 14,000 Black kidney transplant candidates so far given credit for lost waiting time, moving them up the priority list for their transplant.“I remember just reading that letter over and over again,” said Evans, 29, of Philadelphia, who shared the notice in a TikTok video to educate other patients. “How could this happen?”