In a televised announcement at 10:29 p.m.,

, who co-authored the journal paper and joined the FDA webcast.Prasad and Makary criticized the U.S.’s “one-size-fits-all,” contrasting it with some European countries that recommend boosters based on age, risk and other factors.

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.

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WASHINGTON (AP) — Democrats and Republicans alike raised concerns on Wednesday about deep staffing cuts, funding freezes and far-reaching policy changes overseen byThis week, the 54-year-old grasped a walker and took her first few steps.

“I was at the end of my rope,” Pisano told The Associated Press. “I just took a chance. And you know, worst case scenario, if it didn’t work for me, it might have worked for someone else and it could have helped the next person.”Dr. Robert Montgomery, director of NYU Langone Transplant Institute, recounted cheers in the operating room as the organ immediately started making urine.

Lisa Pisano looks at photos of her dog after her surgeries at NYU Langone Health in New York on Monday, April 22, 2024. Doctors transplanted a pig kidney into Pisano, who was near death, part of a dramatic pair of surgeries that also included a fix for her failing heart. (AP Photo/Shelby Lum)Lisa Pisano looks at photos of her dog after her surgeries at NYU Langone Health in New York on Monday, April 22, 2024. Doctors transplanted a pig kidney into Pisano, who was near death, part of a dramatic pair of surgeries that also included a fix for her failing heart. (AP Photo/Shelby Lum)