By\u00a0\u00a0MATTHEW PERRONE\u00a0and\u00a0LAURAN NEERGAARD AP News<\/p>\n\n\n\n
WASHINGTON (AP) \u2014 Robert F. Kennedy Jr.<\/a> clinched the political support needed to become the nation\u2019s top health official by pledging to work within<\/a> 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.<\/p>\n\n\n\n The Food and Drug Administration<\/a> will soon \u201cunleash a massive framework\u201d for how vaccines are tested and approved, according to Commissioner Marty Makary<\/a>. Details aren\u2019t yet public but the plan is being overseen by the agency\u2019s new vaccine chief, Dr. Vinay Prasad<\/a>, an outspoken critic of FDA\u2019s handling of COVID-19 boosters.<\/a><\/p>\n\n\n\n Makary and other Trump administration officials already have taken unprecedented steps that raise uncertainty about next fall\u2019s COVID-19 vaccinations, including delaying FDA scientists\u2019<\/a>full approval<\/a> of Novavax\u2019s shot<\/a> \u2014 and then restricting its use to people at higher risk from the virus. They\u2019ve also suggested seasonal tweaks<\/a> to match the latest circulating virus strains are new products requiring extra testing.<\/p>\n\n\n\n The changes cross multiple health agencies.<\/a><\/p>\n\n\n\n The Centers for Disease Control and Prevention hasn\u2019t yet acted on an influential advisory panel\u2019s recent recommendations<\/a> on use of a new meningitis shot or broader RSV vaccination. A meeting of Kennedy\u2019s \u201cMake America Healthy Again\u201d<\/a> allies was recently told to expect an end to COVID-19 booster recommendations for children \u2014 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.<\/p>\n\n\n\n \u201cI think you have to assume that RFK Jr.\u2019s intention is to make it harder for vaccines to come to market,\u201d said Dr. Amesh Adalja, a vaccine expert at Johns Hopkins University. The changes are \u201clooked at suspiciously because this is someone with a proven track record of evading the value of vaccines.\u201d<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Sen. Bill Cassidy, a Louisiana Republican who chairs the committee, briefly interrupted the hearing to say, \u201cFor the record, that\u2019s not true\u201d \u2014 pointing to placebo-controlled studies of the rotavirus, measles and HPV vaccines.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n \u201cIt directly debunks the claim that vaccines were never tested against placebo,\u201d said Dr. Jake Scott, a Stanford University infectious disease physician who\u2019s helping lead the project.<\/p>\n\n\n\n Antivaccine groups argue that some substances scientists call a placebo may not really qualify, although the list shows simple saline shots are common.<\/p>\n\n\n\n Sometimes a vaccine causes enough shot-site pain or swelling that it\u2019s evident who\u2019s getting the vaccine and who\u2019s in the control group \u2014 and studies might use another option that slightly irritates the skin to keep the test \u201cblinded,\u201d Scott explained.<\/p>\n\n\n\n And when there\u2019s already a proven vaccine for the same disease, it\u2019s unethical to test a new version against a placebo, he said.<\/p>\n\n\n\n \u201cWe can\u2019t always expect placebo-controlled trials,\u201d Scott said. \u201cIt\u2019s imperative that be communicated clearly to the public, but it\u2019s challenging especially when there\u2019s so much noise in social media and so much misinformation.\u201d<\/p>\n\n\n\n The administration\u2019s promise of a new vaccine framework comes ahead of a Thursday meeting where FDA advisers will discuss updating COVID-19 shots for this fall and winter.<\/p>\n\n\n\n The FDA\u2019s 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 always handled by career scientists.<\/p>\n\n\n\n But that standard appears to be shifting. FDA staffers were poised to approve Novavax\u2019s vaccine<\/a> early last month but the decision was delayed by administration officials, 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 unusual restrictions.<\/p>\n\n\n\n Dr. Tracy Beth Hoeg \u2014 a political appointee serving as Makary\u2019s special assistant \u2014 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\u2019s longtime vaccine chief, Dr. Peter Marks<\/a>, was forced to resign.<\/p>\n\n\n\n Hoeg \u2014 along with Makary and Prasad \u2014 spent much of the COVID-19 pandemic criticizing the FDA\u2019s handling of booster shots, particularly in children and young adults. All three were co-authors of a 2022 paper stating that requiring booster shots in young people would cause more harm than benefit.<\/p>\n\n\n\n Novavax isn\u2019t 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 data.<\/p>\n\n\n\n As the FDA\u2019s top official overseeing vaccines, Prasad is now in position to reverse what he recently called \u201ca number of missteps\u201d in how the FDA assessed the benefits and risks of COVID-19 boosters.<\/p>\n\n\n\n He questioned how much benefit yearly vaccinations continue to offer. In a podcast shortly before assuming his FDA job, Prasad suggested companies could study about 20,000 older adults in August or September to show if an updated vaccine prevented COVID-related hospitalizations.<\/p>\n\n\n\n There is \u201clegitimate debate about who should be boosted, how frequently they should be boosted and the value of boosting low-risk individuals,\u201d said Hopkins\u2019 Adalja. But he stressed that CDC\u2019s Advisory Committee on Immunization Practices has the proper expertise to be making those decisions.<\/p>\n\n\n\n And other experts say simply updating the strain that a COVID-19 vaccine targets doesn\u2019t make it a new product \u2014 and real-world data shows each fall\u2019s update has offered benefit.<\/p>\n\n\n\n \u201cThe data are clear and compelling\u201d that vaccination reduces seniors\u2019 risk of hospitalization and serious illness for four to six months, said Michael Osterholm, a University of Minnesota infectious disease researcher.<\/p>\n\n\n\n Nor could that kind of study be accomplished quickly enough to get millions of people vaccinated before the yearly winter surge, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.<\/p>\n\n\n\n \u201cYou\u2019d always be doing clinical trials and you\u2019d never have a vaccine that was up to date,\u201d he said.<\/a><\/p>\n\n\n\nRaising doubts about vaccines<\/h2>\n\n\n\n
Trump officials held up vaccine decision<\/h2>\n\n\n\n
COVID-19 booster critics are in control<\/h2>\n\n\n\n