![]() Send news, tips and compliments to David Lim ( or or Katherine Ellen Foley ( or OUR PULSE CHECK PODCAST, host Ben Leonard talks with Robert King, who reports on a Senate panel that’s investigating the frequency of Medicare coverage denials for beneficiaries and the use of artificial intelligence - and the panel is beginning by demanding records from the largest Medicare Advantage insurers: Humana, UnitedHealthcare and CVS. The FDA’s Brian King told attendees at the Food and Drug Law Institute’s annual conference this week that Reagan-Udall’s review of the agency’s tobacco program felt like “baptism by blowtorch.” That resonates deeply with your co-hosts. What’s next: The FDA will decide on Pfizer’s RSV vaccine for infants in August. Merck is developing a similar monoclonal antibody for RSV in infants, but the company hasn’t released clinical data yet. The European Commission approved the antibody last year. The FDA’s advisers will meet in June to discuss the companies’ application, and the agency will decide by the end of September. Though not a vaccine, the antibody would offer some protection against the disease during babies’ first RSV season, which typically occurs over the fall and winter, and for the first and second RSV seasons for babies with additional health risks. The CDC estimates the viral infection results in up to 80,000 pediatric hospitalizations annually and as many as 300 deaths.Ī growing landscape: Sanofi and AstraZeneca have asked the FDA to approve a monoclonal antibody RSV treatment for infants. Given the risk of infants developing severe disease tied to RSV, outside experts decided the benefits outweighed the risks. ![]() The panel voted 10-4 that the vaccine was safe for babies, citing concerns that some data indicated the shot could lead to risky pre-term births. In late-stage clinical trials, the vaccine was more than 80 percent effective at preventing severe RSV in newborns up to 3 months old and about 70 percent effective at preventing severe disease in babies up to 6 months old.īut they had some safety concerns. | Brandon Bell/Getty ImagesįIRST RSV VACCINE FOR BABIES ENDORSED - Independent advisers unanimously recommended Thursday that the FDA approve the first vaccine that protects infants against respiratory syncytial virus.Īdvisers voted 14-0 that Pfizer’s vaccine candidate, administered to pregnant individuals in their second or third trimester, demonstrated that it would effectively protect infants from severe cases of the disease. A vaccine that protects infants from RSV is one step closer to FDA approval.
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