FDA ADVISERS TO VOTE ON RSV VACCINES — The FDA’s Vaccine and Related Biological Products Advisory Committee convenes a two-day meeting today to consider recommending two new respiratory syncytial virus vaccinations for adults 60 years and older. If recommended and the FDA then approves them, the candidates from Pfizer and GSK would be the first vaccines against RSV for any age group. The RSV vaccine pipeline came into the spotlight this past holiday season when a trifecta of respiratory viruses — the flu, Covid-19 and RSV — put health officials nationwide on high alert for an overwhelming number of hospitalizations. Typically, RSV produces a mild, coldlike illness in healthy adults but can be dangerous for young children, older adults and those with compromised immune systems. Federal researchers started working on a vaccine in the 1960s but abruptly halted when a candidate made some pediatric trial participants susceptible to more severe illness from RSV, leading to two deaths. It wasn’t until a decade ago that researchers made the breakthrough to develop a safer effective candidate. FDA advisers will discuss and vote on whether to recommend Pfizer’s RSV candidate today. The company, which asked the FDA in December to approve its vaccine candidate, reported Phase III trial results demonstrating the vaccine was 66.7 percent effective at protecting against RSV with two or more symptoms and 85.7 percent effective at preventing RSV with three or more symptoms. However, the FDA raised concerns that Pfizer couldn’t provide data on the duration of immunity or protection for those who are 80 years and older or have compromised immune systems. It also raised concerns that two in nearly 20,000 people who received the vaccine developed Guillain-Barré syndrome, a dangerous autoimmune condition that damages the body’s nervous system. Guillain-Barré cases for adults 60 and older in trials are typically no more than three per 100,000 adults. On Wednesday, the expert panel will consider GSK’s vaccine, which in late-stage clinical trials was more than 82 percent effective at preventing lab-confirmed RSV among adults 60 and older. One case of Guillain-Barré was reported among the roughly 15,000 participants that received the vaccine. The FDA’s advisers will consider the benefits of those vaccines — plus the fact that the risk of severe autoimmune reactions like Guillain-Barré syndrome due to viral infections increases with age, regardless of a person’s vaccination status. At the end of both days, they’ll vote on whether they’ll recommend the agency approve these candidates. The FDA isn’t obligated to follow its expert advice, though it often does. Either way, the agency is slated to make a final approval decision in May. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Rep. Alexandria Ocasio-Cortez (D-N.Y.) is talking with Energy and Commerce ranking member Frank Pallone (D-N.J.) about the FDA’s regulation of sunscreen — which she described Monday on Instagram as “woefully behind.” 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, Megan Messerly talks with host Alice Miranda Ollstein about the yearlong deadline for states to assess whether their residents on Medicaid are still eligible for the program — and Arkansas' plans to finish its assessment in half the time. Megan previews what could be in store for Medicaid there and in other states.
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