A one-stop shot for annual vaccines?

Presented by the American Heart Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Apr 25, 2023 View in browser   By Katherine Ellen Foley and David Lim Presented by the American Heart Association Driving the day A once-a-year flu/Covid combo vaccine could be on the horizon. | LM Otero/AP Photo TIME TO STREAMLINE SHOTS — Pharmaceutical companies and public health experts are eyeing ways to make vaccinations more accessible, considering the low uptake of bivalent Covid-19 boosters and annual flu shots. They envision a single jab that could offer yearly protection against respiratory viruses like Covid, the flu and respiratory syncytial virus. Vaccination uptake for Covid and the flu are subpar: About 20 percent of adults have received a bivalent booster and less than half of adults got a flu shot this year, according to the CDC. “It could be, in time, adult vaccinations will start to resemble pediatric vaccinations,” Peter Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, told Prescription Pulse. Children routinely get combination shots such as MMR (measles, mumps and rubella) or DTaP (diphtheria, tetanus and pertussis) to reduce the number of needles they need at the doctor’s office. Advisers to the CDC said there could potentially be annual Covid-19 boosters, similar to the annual flu shot. The natural extension for several companies — including Pfizer, Moderna and Novavax — is to combine the two shots. The combo candidates are in early- to mid-stage clinical trials. But regulators are interested: Pfizer has received fast-track designation from the FDA, which would speed up the review process; the company is still in the first phase of testing. And, in addition to testing a combo Covid/flu shot, Moderna has a vaccine that would protect against Covid, flu and RSV in early-stage trials. Novavax is conducting Phase II trials of a combo Covid/flu vaccine. Aside from proving safety and efficacy, manufacturers will need to show that their products generate full immune responses for the flu and Covid, Hotez said. Already, the CDC allows health care providers to administer Covid and flu vaccines at the same time. One big question for vaccine makers is what kind of data will the FDA require for combination vaccinations, Filip Dubovsky, Novavax’s president of research and development, told Prescription Pulse. The FDA doesn’t require drugmakers to conduct new clinical studies for the flu vaccine every year. The strain of the vaccine is updated annually. “That’s kind of where we’re edging to on the Covid side,” Dubovsky said. The CDC has already taken the first step in simplifying recommended shots. Under newly adopted guidelines, most adults have optimal Covid protection if they have at least one updated bivalent mRNA-based vaccine. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. We’re thrilled to be welcoming Robert King to join our team covering the Centers for Medicare and Medicaid Services today. Welcome, Robert! Send news, tips and compliments to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Megan Messerly, who explains how bans on gender-affirming care in red states are impacting doctors who provide such care to transgender adolescents in blue states and threatening health care access for their trans youth patients. Listen to today’s Pulse Check podcast   A message from the American Heart Association: For decades, the tobacco industry has used menthol cigarettes and flavored cigars to hook new users. The flavors attract youth and young adults, make cigarettes and cigars easier to smoke and make it more likely that experimental users will become regular users. Menthol also makes it harder to quit. One year ago, the FDA proposed ending the sale of these highly addictive, deadly products. Now it’s time for FDA to finish the job. Learn more.   In Congress CMS Administrator Chiquita Brooks-LaSure will testify before the House E&C Health Subcommittee on Wednesday. | Chip Somodevilla/Getty Images WELCOME BACK TO THE HOT SEAT — CMS Administrator Chiquita Brooks-LaSure is slated to testify before Congress on Wednesday for the first time since being confirmed. Expect House Energy and Commerce Health Subcommittee lawmakers to hone in on CMS’ treatment of drugs that received accelerated approval from the FDA. Alzheimer’s drug coverage debate: CMS declined to revisit its limited coverage determination of drugs like Leqembi and Aduhelm earlier this year after the Alzheimer’s Association formally requested it reconsider the earlier decision. Currently, Medicare covers the drugs for only beneficiaries enrolled in an FDA- or NIH-cleared clinical trial — of which none are enrolling. The Department of Veterans Affairs will cover the drugs for its beneficiaries, however, which has led those in the Alzheimer’s community to feel “confused and angry,” said Robert Egge, chief public policy officer of the Alzheimer's Association. Earlier this year, 74 bipartisan lawmakers in the House wrote to Brooks-LaSure in support of the agency broadening its coverage, including Rep. Mariannette Miller-Meeks,(R-Iowa), who serves on the subcommittee. George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, also speculated that ranking member Rep. Anna Eshoo (D-Calif.) may question LaSure on the drugs’ limited coverage. The hearing — a bipartisan effort to address health care costs — is slated to consider a number of bills and discussion drafts on different policies, including transparency requirements on pharmacy benefit managers and diagnostic laboratories.   GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat.     Around the Agencies EPA JOSTLED WITH OTHER AGENCIES OVER ETHYLENE OXIDE — The EPA received feedback during an interagency review for its proposed restrictions on ethylene oxide, raising concern that the agency did not adequately take into account the regulation’s potential disruption of the medical device supply chain, according to interagency notes recently posted on regulations.gov. The proposed rule, posted on April 13, acknowledged that to implement emission capture and reduction systems, “facilities will need to cease operations for a certain period of time.” The notes say that “these shutdowns typically last at least a week but may be longer” and the “EPA does not have methods to estimate how long facilities might close or what the lost revenues might be.” The interagency comments also say such costs “are not included in the cost estimates” and much of the responsibility to ensure an “adequate supply of medical devices” would fall on the FDA. Much of this coordination would be led by the FDA, as the EPA has worked to inform them of facility closures over the past few years to "ensure that the supply of medical devices is not adversely impacted,” the notes say.   A message from the American Heart Association:   Eye on the FDA NEW PRESCRIPTION DRUG ADVERTISING STUDY — The FDA said Monday it plans a study examining quantitative claims in direct-to-consumer drug advertising because the agency does not have enough information about how consumers interpret the use of mathematical medians to characterize how well a drug works.   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.     Quick Hits Gender-affirming health care restrictions in red states are shrinking access in blue states, Megan Messerly reports for POLITICO. Document Drawer The Office of Information and Regulatory Affairs received from CMS a proposed rule on short-term limited-duration insurance plans for review on April 20. It also received from CMS a proposed rule containing calendar 2024 changes to the end-stage renal disease prospective payment system and quality incentive program for review on April 21.   A message from the American Heart Association: It’s time to stop the tobacco industry from profiting off products that kill. Almost half a million people in the U.S. die from smoking each year and 16 million people across the country are living with a smoking-related disease. Menthol cigarettes and flavored cigars are a big part of the problem. Big Tobacco uses menthol cigarettes and flavored cigars to attract and addict new smokers, aggressively targeting Black and Hispanic people and other communities of color, the LGBTQ+ community and youth. Last year the FDA took a historic step – proposing to remove menthol cigarettes and all flavored cigars from the market. A year has passed. Join us and tell FDA it’s time to finish the job. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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