RFK Jr. pledged not to upend US vaccine system, but big changes are underway

By MATTHEW PERRONE and LAURAN NEERGAARD Associated Press WASHINGTON AP Robert F Kennedy Jr clinched the political encouragement needed to become the nation s top wellness 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 constituents 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- boosters Makary and other Trump administration executives already have taken unprecedented policies that raise uncertainty about next fall s COVID- vaccinations including delaying FDA scientists full approval of Novavax s shot and then restricting its use to people at higher peril from the virus They ve also suggested seasonal tweaks to match the latest circulating virus strains are new products requiring extra testing Food and Drug Administration FDA commissioner Marty Makary speaks during a news conference on the FDA s intent to phase out the use of petroleum-based synthetic dyes in the nation s food supply at the Hubert Humphrey Building Auditorium in Washington Tuesday April AP Photo Jose Luis Magana The changes cross multiple vitality agencies The Centers for Condition Control and Prevention hasn t yet acted on an influential advisory panel s newest recommendations on use of a new meningitis shot or broader RSV vaccination A meeting of Kennedy s Make America Healthy Again allies was in recent weeks communicated to expect an end to COVID- booster recommendations for children something that vaccine advisory panel was supposed to debate in June And researchers around the country lost National Institutes of Medical funding to review vaccine hesitancy I think you have to assume that RFK Jr s intention is to make it harder for vaccines to come to industry mentioned 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 physical condition committee hearing last week Kennedy wrongly claimed that the only vaccines tested against a placebo or dummy shot were for COVID- Related Articles JD Vance gives Pope Leo XIV an invitation from Trump to visit US Trump s big bill advances in rare weekend vote but conservatives demand more changes Trump hopes for ceasefire progress in Russia-Ukraine war in Monday calls with Putin and Zelenskyy Lucas Will Healey show for judge s hearing She should Speaker looks to get tax bill back on track 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 in the past few days compiled a list of more than vaccine clinical trials spanning decades the majority 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 reported Dr Jake Scott a Stanford University infectious affection physician who s helping lead the project Antivaccine groups argue that selected 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 sickness it s unethical to test a new version against a placebo he mentioned We can t inevitably expect placebo-controlled trials Scott reported It s imperative that be communicated clearly to the general but it s challenging especially when there s so much noise in social media and so much misinformation Trump officers held up vaccine decision The administration s promise of a new vaccine framework comes ahead of a Thursday meeting where FDA advisers will discuss updating COVID- shots for this fall and winter The FDA s credibility has long rested on the independence of its scientific decisions While the agency is led by a handful of political appointees approval decisions are almost unfailingly handled by career scientists But that standard appears to be shifting FDA staffers were poised to approve Novavax s vaccine early last month but the decision was delayed by administration executives including Makary according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss agency matters The shot was approved late Friday with strange restrictions Dr Tracy Beth Hoeg a political appointee serving as Makary s special assistant was involved in the unprecedented demand that Novavax conduct a new clinical trial of its shot after approval according to the people The requirement came shortly after the agency s longtime vaccine chief Dr Peter Marks was forced to resign Hoeg along with Makary and Prasad spent much of the COVID- pandemic criticizing the FDA s handling of booster shots particularly in children and young adults All three were co-authors of a paper stating that requiring booster shots in young people would cause more harm than benefit Novavax isn t the only vaccine manufacturer already affected by changing attitudes at FDA Earlier this month Moderna pushed back the target date for its new COVID-and-flu combination vaccine to next year after the FDA requested additional effectiveness details COVID- booster critics are in control As the FDA s top official overseeing vaccines Prasad is now in position to reverse what he of late called a number of missteps in how the FDA assessed the benefits and risks of COVID- boosters He questioned how much benefit yearly vaccinations continue to offer In a podcast shortly before assuming his FDA job Prasad suggested companies could survey about older adults in August or September to show if an updated vaccine prevented COVID-related hospitalizations There is legitimate debate about who should be boosted how frequently they should be boosted and the value of boosting low-risk individuals noted Hopkins Adalja But he stressed that CDC s Advisory Committee on Immunization Practices has the proper expertise to be making those decisions And other experts say merely updating the strain that a COVID- vaccine targets doesn t make it a new product and real-world figures shows each fall s update has offered benefit The facts are clear and compelling that vaccination reduces seniors vulnerability of hospitalization and serious illness for four to six months explained Michael Osterholm a University of Minnesota infectious condition researcher Nor could that kind of scrutiny be accomplished expeditiously enough to get millions of people vaccinated before the yearly winter surge stated Dr Jesse Goodman of Georgetown University a former FDA vaccine chief You d invariably be doing clinical trials and you d never have a vaccine that was up to date he announced The Associated Press Wellness and Science Department receives aid from the Howard Hughes Health Institute s Science and Educational Media Group and the Robert Wood Johnson Foundation The AP is solely responsible for all content