White House tees up pediatric Covid-19 vaccine strategy

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Jun 10, 2022 View in browser   By Lauren Gardner, David Lim and Katherine Ellen Foley Presented by Nomi Health On Tap — The White House is winding up its latest Covid-19 vaccination push: Getting shots in the arms of kids under 5. — The House passes its FDA user fee reauthorization package; the Senate HELP Committee is now set to mark up its bill next week. — The FTC will open an inquiry into the business practices of pharmacy middlemen. It's Friday. Welcome back to Prescription Pulse. We're intrigued by the ongoing fuss about NASA's new study examining unmanned aerial phenomena. 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).   A message from Nomi Health: If not us, who? We're looking to Congress to help us bring care – like free COVID-19 testing – to the un- and under-insured. Learn more.   Coronavirus If and when Covid-19 vaccines for kids under 5 get the green light, the Biden administration has a plan for that. | Getty Images WHITE HOUSE OUTLINES PEDIATRIC VAX STRATEGY — The Biden administration began telegraphing this week how it expects to distribute — and educate the public about — Covid-19 vaccines for children under 5, should the FDA and CDC authorize and recommend the shots next week. Officials are already signaling what anyone looking at the vaccination rates for older kids might expect: They're playing the long game. The administration expects most parents to have their pediatricians or primary care providers immunize their kids, but it's also working to ensure vaccines will be available at health centers, rural health clinics, children's hospitals and pharmacies to ensure access for people who may not have, as the National Association of County and City Health Officials' Adriane Casalotti put it, "a medical home." Officials also anticipate that appointments could be difficult to come by in the vaccination effort's early days. Still, the preorder numbers to date are low. The administration is initially making 10 million doses available, with millions more to come in the following weeks. But of the 5 million offered for preorder last week, less than half were snapped up, a senior administration official said Wednesday. Most were Pfizer-BioNTech vaccines even though an equal number of those shots and Moderna's were offered. It's also unclear what might happen if the FDA and CDC opt to authorize and/or recommend one vaccine over the other. Kids ages 6 months to 5 years are the only pediatric population that might have two vaccines to choose from at the outset. Data reported by the companies suggest that Pfizer's three-dose series offers greater efficacy against symptomatic disease than Moderna's two-shot regime, but Pfizer is expected to submit updated effectiveness data once more kids in its trial develop Covid post-third dose. "Should we end up with only one vaccine authorized, which we're not anticipating or prejudging whether that might happen, we will adjust supply accordingly," said Dawn O'Connell, HHS' assistant secretary for preparedness and response. Trusted messengers: HHS is collaborating with several organizations — including the American Academy of Pediatrics, the Association of Children's Museums and local community-focused groups — to launch a public education campaign that would answer the questions of parents who may be undecided about inoculating their young children against Covid-19. Vaccine confidence "builds with trusted voices, physicians, faith leaders, others helping people get vaccinated," said White House Covid Response Coordinator Ashish Jha. "This is not a one-and-done; this is not an automatic." CDC schedules advisory meeting: CDC's independent vaccine advisory committee will discuss pediatric Covid-19 vaccines on June 17 and 18, Katherine reports. The agendas will likely be finalized after FDA's vaccine advisory committee meets Tuesday and Wednesday. MODERNA ANNOUNCES PROMISING RESULTS FROM OMICRON-SPECIFIC BOOSTER — An Omicron-specific booster shot from Moderna produced a superior immune response in adults against the variant than the original booster, the company said Wednesday. Moderna executives will be presenting early data at the FDA's independent advisory committee meeting discussing future boosters later this month, although the group will consider fall boosters more broadly. In a conference call, Moderna president Stephen Hoge said the company would also study the bivalent shot as boosters and a primary series for children. "We have patients in our under-5 studies who have received placebo, and we have an opportunity to cross them over and give them a bivalent vaccine," he said. FDA ADVISERS RECOMMEND NOVAVAX SHOT — FDA's independent vaccine advisers overwhelmingly voted to recommend emergency use authorization of Novavax's two-dose Covid-19 vaccine as a primary series for adults on Tuesday. Committee members signaled interest in bolstering the U.S.' immunization arsenal with an option made using different vaccine technology — in this case, a protein-based product — that may appeal to the vaccine-hesitant and those with other reasons for choosing not to receive messenger RNA shots. But it's unclear when the FDA will make a final call on authorizing the vaccine. Novavax told the FDA it had changed the manufacturing process for its vaccine after the agency scheduled Tuesday's advisory committee meeting, FDA spokesperson Abby Capobianco said. The company submitted an amendment to its EUA request on June 3 with updated manufacturing and product information, meaning the FDA will need to review additional data before making a decision.   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     In Congress HOUSE PASSES FDA USER FEE PACKAGE — The House late Wednesday passed a legislative package to reauthorize FDA's medical product user fee programs in a 392-28 suspension vote. The legislation, which extends the agency's brand drug, generic drug, biosimilar and medical device user fee programs for another five years, also contains several riders, including efforts to boost clinical trial diversity and tweaks to the FDA's accelerated approval pathway. SENATE TEES UP RESCHEDULED USER FEE MARKUP — After running into challenges reaching an agreement on a manager's amendment earlier this week, the Senate HELP Committee pushed back its user fee reauthorization package markup to next Tuesday. Sen. Richard Burr (R-N.C.), the committee's ranking Republican, told Lauren this week that FDA's handling of the infant formula crisis is "part of those negotiations" and that he's suggested the bill include "some reports" on the issue. SENATE CONFIRMS HHS GENERAL COUNSEL — The Senate on Thursday confirmed Samuel Bagenstos as HHS general counsel in a 49-43 vote. Around the Agencies FTC TO PROBE PBM PRACTICES — The Federal Trade Commission unanimously voted Tuesday to study the business practices of pharmacy benefit managers , the middlemen that negotiate rebates from pharmaceutical companies and develop lists of prescription drugs that insurers will cover, POLITICO's Megan R. Wilson writes. The review will allow the agency to issue subpoenas to six PBMs and compel them to disclose information about their contracts with pharmacies and how they develop formularies for covered drugs, among other issues. Eye on FDA FDA: REMOVING SKIN GROWTHS NOT A PERSONAL PROJECT — People who develop moles, seborrheic keratoses and skin tags should seek professional care to have their growths removed instead of taking a do-it-yourself approach, FDA cautioned Thursday. Relying on products that contain salicylic acid or other "harmful ingredients" can risk "skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment," according to the agency. "Currently, there are no U.S. Food and Drug Administration approved prescription or over-the-counter (OTC) drugs for treating moles, seborrheic keratoses, or skin tags," FDA said. "But there are potentially dangerous products being sold that claim to help remove these lesions."   A message from Nomi Health:   Tobacco Sen. Dick Durbin has given the FDA commissioner an ultimatum: either ban the sale of unauthorized vape products or resign. | Francis Chung/E&E News/POLITICO DURBIN CALLS FOR CALIFF TO STEP DOWN OVER E-CIG REGULATION DELAYS — On Thursday, Sen. Dick Durbin (D-Ill.) called on FDA Commissioner Robert Califf to either rid the market of unauthorized vape products or resign. The agency is more than 9 months past its court-ordered deadline to review vape applications; it is still deliberating products from major market shareholders, including Juul. Those products have remained in stores despite not being officially authorized for sale. "If Commissioner Califf feels no urgency to follow the law and a court order to protect our children from the dangers of nicotine addiction, then he should step aside and let someone else lead," he said in a statement. FDA TO HEAR COMMENTS ON MENTHOL CIG BAN — The FDA's Center for Tobacco Products will hear 12 hours of comments over the course of two listening sessions on June 13 and 15 about its proposed rules to ban menthol cigarettes and flavored cigars. These sessions are designed to give the public a chance to provide verbal comments on the rules; the written comment period will be open until July 5.   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.     Industry Intel PFIZER COMPLETES REVIRAL ACQUISITION — Pfizer has now acquired ReViral and its drug portfolio, the company announced Thursday . ReViral, a biotech company, focuses on developing antiviral candidates that target respiratory syncytial virus and has a candidate that has made it through Phase II clinical trials. Pharma Moves WEDNESDAY: A House Appropriations subcommittee marks up a bill to fund FDA for fiscal year 2023 at 2:30 p.m. EDT. THURSDAY: The Senate HELP Committee holds a hearing on the government's Covid-19 response at 9:30 a.m. EDT. FDA Commissioner Robert Califf will testify alongside other health officials. Pharma Moves Joe Damond joined Edelman Global Advisory as a senior health adviser. Damond previously served as BIO's deputy chief policy officer and executive vice president for international affairs. Kurt Gunter has joined Inozyme Pharma as chief medical officer. He most recently served as chief medical officer, cell therapy, and head of regulatory affairs at Athenex. Sam Samad will leave Illumina on July 8. The company announced that Joydeep Goswami will step in as interim CFO while it searches for a permanent replacement for Samad. Quest Diagnostics announced Samad will become its CFO effective July 11. Quick Hits The U.S. is backing an intellectual property deal at the World Trade Organization that could allow more future generic production of Covid-19 vaccines compared to the existing baseline, but critics say it may be too little, too late, POLITICO's Doug Palmer reports.   A message from Nomi Health: While the pandemic has shifted to a new phase, uninsured Americans still need access to free COVID testing to reduce the strain on our overburdened healthcare system and to keep American workers producing – which will keep our economy moving and help tackle inflation. Read more about our advocacy here.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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