‘Short sighted’: What canceled FDA meetings and WHO withdrawal mean for fall flu vaccines – The Boston Globe

Even as this season’s extended flu outbreak continues to rage, experts around the world are turning their attention to next season’s flu shots.New data from the CDC shows the 2024-2025 flu vaccine reduced doctor’s visits for flu-like symptoms among children and adolescents by up to 60 percent and by up to 54 percent for adults.But, with the recent cancellation of a key vaccine meeting and the United States announcing its withdrawal from the World Health Organization, some worry that the fall 2025 shots will be delayed or in short supply.Here’s what goes into manufacturing the annual influenza vaccine and what recent disruptions mean.The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee had been set to meet March 13, but the FDA sent an email to members saying it had been canceled.AdvertisementThe Department of Health and Human Services, home to the FDA, did not respond to the Globe’s questions about why the meeting was canceled or whether it would be rescheduled.The VRBPAC, with 15 voting members, is composed of academic and industry experts in infectious diseases, immunology, and vaccines. It’s one of the FDA’s 50 committees providing independent science advice to the agency, and its meetings are open to the public. The panel typically meets in February or March each year to discuss and share research on the safety and efficacy of flu vaccines. That includes hearing presentations from the World Health Organization, the Centers for Disease Control and Prevention, and the Department of Defense on flu strains circulating throughout the world, said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a voting member of the VRBPAC. Typically, the vaccine is trivalent, meaning it targets two A type strains and one B strain. Vaccine composition usually changes each year, Offit said.During the meeting, experts examine data from Southern Hemisphere countries that have earlier winters to predict which strains will be dominant in the US. Panelists also perform a “post mortem” on the previous year’s flu season and how well scientists predicted which strains to target, Offit said. Advertisement“There’s vigorous debate and sometimes disagreement because that’s the way it should work,” he added. “This is a group of experts in the field who are independent of the government and independent of the pharmaceutical industry.”The committee meets early in the year because it usually takes about six months for pharmaceutical companies to produce the vaccine.“If you want a vaccine available for the fall, the strains included have to be decided by springtime,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, adding that the meeting’s cancellation is a “clear departure from prior practice.”The VRBPAC usually follows guidelines set out by the World Health Organization in February about which viruses to target. But on his first day in office, Trump signed an executive order withdrawing the US from WHO. Offit said this is unlikely to impact the decisions the FDA makes about the flu vaccine. because experts from both organizations usually come to similar conclusions.“It’s just disappointing to see that the tone is one of rejection of federal expertise regarding public health,” Offit said.Once the FDA decides which strains to target, manufacturers begin the process of including the killed or weakened viruses in their vaccines, which are then formulated into standard doses for distribution. Doses are released in late summer, according to the FDA. The FDA has used advisory committees for the evaluation of drugs since the 1960s. Barouch said that even though the FDA has internal staff that could make these decisions by themselves, it’s important to have external input, especially from academics.Advertisement“It brings external experts from around the country, as well as an opportunity for debate and public comment,” he said.Flu vaccines are updated each year because the virus is constantly changing and mutating. Each year’s vaccine is designed to target specific surface proteins of flu viruses, which evolve as they infect more people. The cancellation of the VRBPAC meeting follows the postponement of a meeting last week of an independent panel of experts that advises the Centers for Disease Control and Prevention on vaccines. The changes have sparked concern among the scientific community about how the government will handle vaccine policy in the wake of Robert F. Kennedy Jr.‘s confirmation as secretary of Health and Human Services.“The concerns are not so much that this particular cancellation will have a substantive impact on the availability of vaccines but that we don’t understand why this meeting was canceled,” said Jennifer Nuzzo, director of the Pandemic Center at Brown University. “We are seeing other actions being taken that are similarly unexplained that raise questions about the administration’s commitments to ensuring that Americans can get the vaccines they need to be protected from serious disease threats like influenza.”Offit said the FDA has promised to pick strains to target on its own and that there will be no delay in vaccines.“We should want to anticipate that there wouldn’t be any difference in the quality of the vaccines in terms of safety or efficacy, and I think that’s probably right,” he said. “But it’s a little concerning that the choice is to bring this all in-house and not have these decisions subject to an external advisory committee from which the public benefits.”AdvertisementDr. Syra Madad, an infectious disease specialist at Harvard’s Belfer Center for Science and International Affairs and Chief Biopreparedness Officer at New York City’s hospital system, said the canceled FDA meeting appears to be another step toward the “dismantling of our public health infrastructure in this country.”She said infectious disease specialists need as much information as possible about what strains of influenza are circulating this season to best prepare for the next season, and scrapping expert input from the advisory committee may impede that insight.“If we don’t have this information, then we may not have a really great flu vaccine this upcoming flu season,” she said. “It may not even give pharmaceutical companies enough time to ramp up production, and we may start seeing spot shortages of flu vaccine next season.”Dr. David Hamer, professor of global health and medicine at Boston University, said uncertainty about whether these meetings will be eliminated completely is concerning.“Theoretically it could lead to a poor choice for the targets they put in a vaccine and therefore a potentially even worse influenza season next year,” he said.In all, Hamer called the move “short-sighted.”“Cancelling advisory meetings like this that are very important, especially for vaccine preventable diseases as well as other public health issues is not great,” he said. “It might save money today, but it may be a lot more expensive tomorrow in terms of the risk for a broader epidemic or pandemic.”Kay Lazar of the Globe staff contributed reportingEmily Spatz can be reached at emily.spatz@globe.com. 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Source: https://www.bostonglobe.com/2025/03/03/metro/fda-cancels-flu-vaccine-meeting/