FDA advisers tackle the first RSV vaccines

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Feb 28, 2023 View in browser   By Katherine Ellen Foley and David Lim Driving the Day FDA advisers could recommend that the agency approve two first-time vaccines for respiratory syncytial virus, shown in the image above. | CDC via AP 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.   DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID.     Listen to today’s Pulse Check podcast Tobacco The Society for Research on Nicotine and Tobacco holds its annual meeting this week. | Patrick Sison/AP Photo SRNT GATHERING TO FOCUS ON TOBACCO REGULATION — This week, the Society for Research on Nicotine and Tobacco will convene in San Antonio for its annual meeting. SRNT doesn’t allow members affiliated with the tobacco industry to attend — a policy that organizers instated in 2021. Brian King, the director of the FDA’s Center for Tobacco Products, will kick off the three-day event with opening remarks about the agency’s progress on tobacco regulation at 1:30 p.m. CST. Eyes emoji: King’s update on CTP will come after the center responded to the Reagan-Udall’s review of the FDA’s tobacco regulatory operations. King pledged to create an Office of Policy to clearly outline CTP’s priorities, call on its advisory committee for help at least annually and pursue user fees for the products it regulates, including e-cigarettes. Are you attending SRNT? Reach out to Katherine to say hi at kfoley@politico.com.  SUPREME COURT DECLINES TO HEAR RJR CASE — The Supreme Court said Monday it would not hear the case tobacco giant R.J. Reynolds filed against Los Angeles County in California. The company escalated the 2020 case to the Supreme Court following a California statewide ban on most flavored tobacco products, including menthol cigarettes. In November, California voters chose to uphold the flavor ban, which went into effect in December. The Los Angeles case could have overturned the statewide ban, but now it will not. Eye on the FDA DUNN DEPARTS — Top FDA regulator Billy Dunn, who led the review of Biogen’s controversial Alzheimer’s drug Aduhelm, has left the agency, according to an internal email sent Monday by the agency’s Office of New Drugs Director Peter Stein. “Billy has decided to retire from FDA and explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases,” Stein wrote. Teresa Buracchio, who has served as acting deputy director of the FDA’s Office of Neuroscience since November, is stepping in as acting director. In addition, she has been appointed permanently to the deputy director role. MEDICAL DEVICES FIRST OTC FLU/COVID TEST AUTHORIZED — On Friday, the FDA authorized emergency use of the first over-the-counter test that can detect both Covid-19 and the flu. But the test maker — Lucira Health — is in the midst of a Chapter 11 bankruptcy filing and trying to find a buyer. “The Company anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, though the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season,” Lucira Health said in a press release Wednesday. The company said it intends to continue normal operations while pursuing a sale. Around the Agencies DEA FLOATS REVOKING PANDEMIC TELEHEALTH RULES — The Drug Enforcement Administration proposed Friday to reinstate requirements that patients have in-person visits with doctors to get prescriptions for certain medications that the agency had waived during the Covid pandemic, POLITICO’s Ben Leonard reports. If the rule is finalized as proposed, patients seeking drugs like Adderall to treat attention-deficit/hyperactivity disorder or Oxycontin for pain must go to a doctor’s office before they can start taking the drug. The proposed rule would give patients who started those drugs during the pandemic a 180-day grace period to comply with the in-person visit requirement. Quick Hits The CDC is tracking a rise in the prevalence of Shigella bacteria cases resistant to antibiotics it describes as a serious public health threat, CBS News’ Alexander Tin reports. The CDC found evidence of the SARS-CoV-2 virus in more than 80 percent of wastewater from some international flights landing in New York from Aug. 1 to Sept. 9, POLITICO’s Krista Mahr reports. DOCUMENT DRAWER The Universities Allied for Essential Medicines North America filed a citizen petition Monday asking the FDA to boost its enforcement of clinical trial reporting requirements. The FDA cautioned health care providers Monday that Abbott Trifecta heart valves have a potential risk of early structural deterioration. The FDA issued draft guidance Friday for drugmakers developing neovascular, or wet, age-related macular degeneration.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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