ALL EYES ON XBB — The FDA’s expert panel on vaccines voted unanimously Thursday to recommend that fall Covid-19 boosters protect against the XBB strain of the virus — an Omicron subvariant and the most prevalent strain worldwide. The Vaccines and Related Biological Products Advisory Committee also agreed that manufacturers should use XBB.1.5 as the specific descendant lineage, which makes up roughly 40 percent of Covid cases in the U.S. The recommendation was in line with what FDA scientists had suggested in their agency presentation. The agency still has to formally direct industry to follow suit, but it often follows its advisers’ guidance. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said, pending data from manufacturers, he anticipated the updated boosters to be rolled out in September. Scheduling conflicts: Marks said he hoped that by adopting a flu-like model in which people get an updated Covid booster this year, more eligible people would get vaccinated. Only 17 percent of those eligible have received bivalent boosters, which were the latest shots federal health authorities endorsed. But advisers argued Thursday it was too soon to be considering annual shots. “We don't really know what the Covid season is,” said committee member Mark Sawyer, a pediatrician and an infectious disease specialist at the University of California, San Diego, School of Medicine. The booster debate: The independent experts also said it wasn’t clear whether everyone would need annual boosters like flu shots and having both on the same schedule might confuse the public. With Covid, “it is likely you could be protected for years against serious to mild illness,” Paul Offit, an attending physician at the Children’s Hospital of Philadelphia and a member of the advisory committee, told Prescription Pulse after the meeting. That’s not the case with the flu, in which annually updated vaccines are strain-specific. Offit said it was premature to say the general population of healthy adults and children will need them without understanding how much individuals will benefit from updated boosters. The benefit of the first Covid vaccines overwhelmingly outweighed the risks, which included swelling of the heart or surrounding tissue in some young adults, he said, but “if it’s not really helpful, then the safety issues become more exaggerated.” A flexible approach: FDA officials assured the committee that recommendations for the future were not set in stone. “If something changes in six months or four months or nine months, we will adjust to it,” Jerry Weir, director of the FDA’s Division of Viral Products in the Office of Vaccines Research and Review, said in the panel’s meeting. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Congratulations to the Republicans for their 16-5 victory at the annual Congressional Baseball Game. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein interviews Megan Messerly about Arkansas' speedy approach to removing ineligible people from the state's Medicaid rolls —and the confusion among many eligible residents who lost their coverage because of procedural reasons like not properly submitting paperwork.
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