CDC advisers to wade into Covid booster debate

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Apr 19, 2022 View in browser   By Lauren Gardner, Katherine Ellen Foley and David Lim On Tap — CDC's external vaccine advisers weigh in this week on the U.S.' Covid booster strategy moving forward. — Federal judge scraps CDC's mask requirement for travel, eliminating one of the last of Biden's Covid-era mandates. — FDA must give quarterly updates on its e-cigarette review. The agency is already more than eight months late in issuing final decisions on some vapes. It's Tuesday. Welcome back to Prescription Pulse. We're still coming down from Peres Jepchirchir's dramatic Boston Marathon win for the women's elite category. Jepchirchir hails from Kenya and completed the race in 2 hours, 21 minutes and 1 second. Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).   SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.     Coronavirus To boost or not to boost? That's the question for the ACIP when advisers meet on Wednesday. | Matt Rourke/AP Photo CDC ADVISERS TO MULL COVID BOOSTER FUTURE — CDC's Advisory Committee on Immunization Practices meets Wednesday to discuss Covid-19 booster shots, weeks after FDA's independent advisers took a jab (vaccine joke!) at hashing out the way forward on additional vaccine doses. Two crucial questions remain: whether and how to reformulate Covid vaccines to cover multiple variants, and who should get boosted and when as the disease transitions to an endemic phase. Manufacturers are still testing variant-specific doses, and Covid has yet to shift to a seasonal cycle of spread like the flu, so don't expect concrete answers just yet. Panel members' goals will likely continue to outline a general approach to addressing those questions as more data accumulate. Another issue to tackle: How to define "vaccine effectiveness" in the Covid context — more specifically, what will the threshold be for companies to rework their vaccine compositions to target different viral strains. At a panel at the World Vaccine Congress in Washington, D.C., vaccine manufacturer execs pointed to protection from severe illness and hospitalization. "It's not just going to be neutralizing antibody titers," Brett Leav, the head of clinical development of public health vaccines at Moderna, said at a panel discussion Monday. Companies will be critically eyeing their products for protectiveness against hospitalizations instead, he said. WAIT IS ON FOR VAX SAFETY DATA FOR PREGNANT PEOPLE — Have we reached a turning point with respect to including pregnant people in more pharmaceutical research because of the pandemic? A panel of maternal health experts at the World Vaccine Conference pointed out that we're on the cusp of gathering large amounts of data now that people who were vaccinated during pregnancy have carried their babies to term, though it'll take years for scientists to draw conclusions on vaccine safety for that population. "It's kind of the long game for us, doing pregnancy studies," Deshayne Fell, associate professor of epidemiology and public health at the University of Ottawa. When asked whether CDC could set up a permanent vaccine-safety surveillance program for pregnant people as it did with v-safe when Covid vaccines became available, an agency official said that approach wouldn't be easy. That's because participation is voluntary, making it difficult to calculate the background rate for adverse events in the population, Pedro Moro, a CDC epidemiologist, said. "You would have to rely on other studies outside the system," he said. Attending the Congress? Find Katherine and Lauren in person today and Wednesday! COURT STRIKES DOWN TRAVEL MASK MANDATE — A Florida-based federal judge on Monday threw out CDC's mask requirement for travel, scrambling one of the Biden administration's only Covid-era mandates left on the books, POLITICO's Alex Daugherty writes. The decision by Donald Trump–appointee Kathryn Kimball Mizelle throws into limbo a rule that spans transportation modes serving the public, from commercial flights to commuter rail. Last week, CDC extended the mandate until May 3, citing the unknowns surrounding the spread of the Omicron subvariant BA.2, which has precipitated an uptick in domestic Covid cases. Despite that increase, the airline industry and some Republicans and Democrats have called for the administration to end the travel mask mandate as states and localities shed their face-covering requirements for other sectors. An administration official said Monday the decision means the Transportation Security Administration will no longer enforce the masking requirement on public transit and at hubs like airports. Still, the official said, "CDC recommends that people continue to wear masks in indoor public transportation settings." Thought bubble: Lauren recently flew and recalls seeing Alaska Airlines advertising this DOD study on plane air quality at the gate — with the caveat that its findings were based on passengers being masked.   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.     In Congress BLUMENTHAL URGES OIG INQUIRY INTO MCKINSEY'S FDA WORK — Sen. Richard Blumenthal (D-Conn.) is calling on the HHS Office of Inspector General to investigate McKinsey & Company's consulting work for FDA while it was simultaneously advising pharmaceutical companies like Purdue Pharma on similar issues. "McKinsey's simultaneous work for the FDA and for FDA-regulated entities not only raises significant concerns about the company's failure to adequately disclose and review conflicts of interest, but also creates critical questions regarding the FDA's failure to identify this major conflict of interest," he wrote in a letter sent last week. RACES TO WATCH — Much is riding on the 2022 midterm elections: the fate of President Joe Biden's agenda, leadership in state capitals across the country and a potential 2024 comeback by former President Donald Trump. In the House, the Democrats' five-seat majority is highly endangered. In the Senate, their control of the 50-50 chamber hinges on Vice President Kamala Harris' tie-breaking vote. Use our Election Forecast to see which races you need to watch this year — and who we think will win each one. In the courts J&J, W.Va. REACH OPIOID SETTLEMENT — West Virginia Attorney General Patrick Morrisey announced Monday a $99 million settlement with Johnson & Johnson's subsidiary Janssen Pharmaceuticals over its role in contributing to the state's opioid crisis. The amount is more than double Janssen's national settlement proposal of $48 million, according to the attorney general's office. The company said in a statement that the settlement is not an "admission of liability or wrongdoing." An additional state suit against other drug companies, including Teva and Allergan, is ongoing. Coming Up in Pharma TUESDAY: Johnson & Johnson holds a Q1 earnings call at 8:30 a.m. EDT. WEDNESDAY: Abbott holds its earnings call at 9 a.m. EDT. THURSDAY: Quest Diagnostics holds its earnings call at 8:30 a.m. EDT. Tobacco FEDERAL JUDGE ORDERS FDA TO PROVIDE PMTA UPDATES — A judge in the U.S. District Court for the District of Maryland told FDA it must provide regular updates on its evaluations of e-cigarette premarket tobacco applications, Katherine reports. The update comes as Judge Paul Grimm granted the motion filed by the American Academy of Pediatrics and other plaintiffs in November 2021. Those same plaintiffs sued FDA for its delay in regulating e-cigarettes in 2018. What's next: The agency's first update is due April 29 and then again every 90 days. Ticktock: Grimm had ordered FDA to decide the fate of e-cigarettes vying to be legally on the market by Sept. 9, 2021. The agency has ordered millions of e-cigarettes off the market and authorized tobacco-flavored vapes from two prominent companies — but it's been silent on household-name vapes, including Juul. Research corner: Many doctors believe e-cigarettes and cigarettes are equally harmful: Scientists from Rutgers University found that in a sample of 2,058 doctors, more than 60 percent believed all tobacco products were equally harmful to users. "As the evidence base grows for e-cigarette efficacy for smoking cessation, there is need for physician education regarding e-cigarette efficacy," the authors wrote. Pharma Worldwide U.S. PLANS GLOBAL COVID-19 SUMMIT IN MAY — The White House announced Monday it will host its Global Covid-19 Summit on May 12, POLITICO's Daniel Payne reports. "In advance of the May 12 Summit, we are calling on world leaders, members of civil society, non-governmental organizations, philanthropists, and the private sector to make new commitments and bring solutions to vaccinate the world, save lives now, and build better health security — for everyone, everywhere," the White House said in its announcement. "The emergence and spread of new variants, like Omicron, have reinforced the need for a strategy aimed at controlling COVID-19 worldwide." The summit was initially set to take place in March and then pushed to April after Ukraine was invaded — and after Congress failed to secure renewed funding for U.S. programs to respond to the pandemic around the world. It was then delayed again, POLITICO first reported. AgencyIQ Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA to look to advisers on VR medical devices — On April 11, the FDA announced a meeting of its Patient Engagement Advisory Committee to discuss the regulation of medical devices that use augmented or virtual reality (AR/VR) platforms. Following the November 2021 marketing authorization for a VR system to treat pain, and another for adolescent behavioral health marketed under pandemic-era authorities, the FDA is looking for recommendations on how to consider risks and benefits when reviewing these devices, as well as the information that patients would want to know about their safe and effective use. FDA has previously raised concerns about AR/VR devices, including whether consumer-grade sensors would be appropriate for medical applications, methods to evaluate the medical uses of the AR/VR devices, and usability testing. The meeting, which is scheduled for July 12-13 , will also see regulatory advisors focus on the unique subpopulations that might benefit from VR products (e.g., people with cognitive disabilities, pediatric or adolescent patients) and how to build these contexts into FDA's pre-market review process. Quick Hits STAT's Katie Palmer and Mario Aguilar take a deep dive into FDA's rapidly growing breakthrough devices program and the medical device industry's lobbying to gain automatic Medicare coverage of such devices if they get marketing authorization. Julie Steenhuysen documents for Reuters the evidence in support of testing Pfizer's Paxlovid as a treatment for long Covid. Document Drawer The National Community Pharmacists Association was scheduled to meet with the White House Office of Information and Regulatory Affairs Monday afternoon to discuss "policy and technical changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs." The Centers for Medicare and Medicaid Services on Monday afternoon published its 1,786-page Hospital Inpatient Prospective Payment Systems proposed rule.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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