Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available. The Food and Drug Administration will soon “unleash a massive framework” for how vaccines are tested and approved, according to Commissioner Marty Makary. Details aren’t yet public but the plan is being overseen by the agency’s new vaccine chief, Dr. Vinay Prasad, an outspoken critic of FDA’s handling of COVID-19 boosters. Makary and other Trump administration officials already have taken unprecedented steps that raise uncertainty about next fall’s COVID-19 vaccinations, including delaying FDA scientists’full approval of Novavax’s shot — and then restricting its use to people at higher risk from the virus. They’ve also suggested seasonal tweaks to match the latest circulating virus strains are new products requiring extra testing. The changes cross multiple health agencies. The Centers for Disease Control and Prevention hasn’t yet acted on an influential advisory panel’s recent recommendations on use of a new meningitis shot or broader RSV vaccination. A meeting of Kennedy’s “Make America Healthy Again” allies was recently told to expect an end to COVID-19 booster recommendations for children — something that vaccine advisory panel was supposed to debate in June. And researchers around the country lost National Institutes of Health funding to study vaccine hesitancy. “I think you have to assume that RFK Jr.’s intention is to make it harder for vaccines to come to market,” said Dr. Amesh Adalja, a vaccine expert at Johns Hopkins University. The changes are “looked at suspiciously because this is someone with a proven track record of evading the value of vaccines.” Raising doubts about vaccines In a Senate health committee hearing last week, Kennedy wrongly claimed that the only vaccines tested against a placebo, or dummy shot, were for COVID-19. Sen. Bill Cassidy, a Louisiana Republican who chairs the committee, briefly interrupted the hearing to say, “For the record, that’s not true” — pointing to placebo-controlled studies of the rotavirus, measles and HPV vaccines. Concerned by rhetoric about how vaccines are tested, a group of doctors recently compiled a list of more than 120 vaccine clinical trials spanning decades, most of them placebo-controlled, including for shots against polio, hepatitis B, mumps and tetanus. “It directly debunks the claim that vaccines were never tested against placebo,” said Dr. Jake Scott, a Stanford University infectious disease physician who’s helping lead the project. Antivaccine groups argue that some substances scientists call a placebo may not really qualify, although the list shows simple saline shots are common. Sometimes a vaccine causes enough shot-site pain or swelling that it’s evident who’s getting the vaccine and who’s in the control group — and studies might use another option that slightly irritates the skin to keep the test “blinded,” Scott explained. And when there’s already a proven vaccine for the same disease, it’s unethical to test a new version against a placebo, he said. “We can’t always expect placebo-controlled trials,” Scott said. “It’s imperative that be communicated clearly to the public, but it’s challenging especially when there’s so much noise in social media and so much misinformation.” Trump officials held up vaccine decision The administration’s promise of a new vaccine framework comes ahead of a Thursday meeting where FDA advisers […]