U.S. may wait until summer to authorize Covid shots for youngest kids

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Apr 22, 2022 View in browser   By Lauren Gardner and David Lim With help from Katherine Ellen Foley On Tap — FDA may wait until June to consider authorizing Covid-19 vaccines for kids under 5. Officials want to make Pfizer's and Moderna's products available simultaneously to minimize confusion. — CDC's vaccine advisory committee comes no closer to a Covid-19 booster strategy. — FDA Commissioner Robert Califf outlines FDA's strategies to combat opioid overdoses on Twitter, highlighting a new rule proposed this week. It's Friday. Welcome back to Prescription Pulse . News you will (probably) never use: Though you'll never exceed the domestic weight limit of the U.S. Postal Service's small, flat-rate shipping box with your earthly belongings, neutron stars will tip the scale. 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 Parents may have to wait until June before the FDA authorizes Covid-19 vaccines for kids under 5. | Jan Pitman/Getty Images FDA MAY HOLD OFF ON KID COVID SHOTS UNTIL JUNE — President Joe Biden's chief medical adviser Anthony Fauci confirmed to CNN's Kasie Hunt Thursday that FDA is considering waiting until early summer to authorize Covid-19 vaccines for children under 5 in an effort to green light products from Pfizer and Moderna simultaneously. His remarks came after POLITICO's Adam Cancryn scooped the details of the administration's thinking: Authorizing the vaccine by Moderna, which plans to complete its emergency use authorization submission by the end of the month, weeks before Pfizer-BioNTech's would make it harder for the government to promote the shots. It could also undermine confidence in their effectiveness, especially if Pfizer's vaccine appears to perform better than Moderna's. But on the flip side, sitting on data for a vaccine FDA expects to authorize is likely to further enrage the parents of young children who have spoken out for months about their frustration as cases have ebbed and flowed thanks to the highly transmissible Omicron variant. Parents complain the goalposts have seemingly moved since children ages 5 to 11 got access to the shots in November when administration officials publicly suggested vaccines for kids as young as 6 months could be available by early 2022. FDA scheduled an advisory meeting in February to consider authorizing Pfizer's vaccine as a two-dose series — with a potential third dose to be added later once more data was collected — only to cancel it days later, which further fanned the flames. Parents on social media plan a pressure campaign to flood FDA's vaccine center with calls urging speedy consideration for the Moderna vaccine once its application is complete. Amy Pisani, CEO of Vaccinate Your Family, told Lauren she believes the public has gained a stronger understanding of the FDA's regulatory process and can accept if one vaccine gains authorization before another. "I think it's a better thing … being staggered," she said on the sidelines of the World Vaccine Congress this week. Moderna timeline update: The company plans to complete its submission for children under 6 by the end of April, spokesperson Colleen Hussey said. It's also updated its submission for teens 12 to 17 with six months' worth of safety data, and it's provided FDA with the submission for 6- to 11-year-olds "that has been approved in 32 other countries," she said. CDC ADVISERS TALK BOOSTERS BUT ARE NO CLOSER ON FUTURE STRATEGY — CDC's independent vaccine advisers deliberated the future of the Covid-19 booster campaign Wednesday but got no closer to recommending a path forward than FDA's advisory panel did earlier this month. But both panels' members agree that offering boosters to people every four to six months is an unsustainable approach for what appears to be an incremental antibody benefit. David Kimberlin, an American Academy of Pediatrics representative to the panel, said now is the time for regulators and the medical community to proactively set a clear goal for the Covid vaccination effort in the U.S., urging that the recommendation be made as simple as possible for average Americans to understand. Members agree that severe disease, hospitalization and death are the three most important outcomes to prevent via vaccination. Some nodded toward the benefit of preventing any Covid infection no matter how mild to stave off long Covid since the condition can occur in both the vaccinated and unvaccinated populations. But Sarah Long, professor of pediatrics at Drexel University College of Medicine, said the scientific community "should not chase the rainbows" in hoping that the existing vaccines will block all infection. IMMUNOLOGISTS CALL FOR FDA TO CHANGE VACCINE DEVELOPMENT GUIDANCE — More than 60 academic researchers and biotech executives have asked FDA to include additional metrics in its vaccine evaluation. The authors, who include Scripps Research's Eric Topol and former Biomedical Advanced Research and Development Authority director Rick Bright, implored the agency in a letter on Thursday to consider T-cell counts, another measure of the adaptive immune response, in addition to antibodies. "Measuring T-cell responses in addition to antibodies is critical to help better evaluate vaccine efficacy and inform decisions regarding ongoing protection against current and future variants," they wrote. Why it matters: FDA's guidance for vaccine makers focuses on reducing symptomatic cases. For young kids, who are hard to enroll in large enough clinical trials, the agency has said manufacturers can rely on comparable antibody data only. WH TO STRATEGIZE INTERNATIONAL COVID AID WITH BUSINESS EXECS — The Biden administration is gathering companies and philanthropies on Tuesday for a private roundtable to discuss how to ensure that developing countries have access to Covid-19 medical countermeasures, according to an invitation obtained by POLITICO. White House Covid-19 response coordinator Ashish Jha and national security adviser Jake Sullivan are slated to speak at the virtual meeting, which will focus on how to get more vaccines into arms and expand access and use of Covid-19 tests and treatments globally. "The discussion will explore a variety of tools including enhanced voluntary technology transfer on mutually agreed terms, [low- and middle-income country] pricing, advanced market commitments, and diversification of manufacturing," a description of the roundtable states.   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.     Eye on FDA FDA has developed several strategies to prevent opioid addiction and overdoses. | Mark Lennihan, File/AP Photo CALIFF OUTLINES AGENCY'S STRATEGIES TO COMBAT OPIOID ADDICTION — FDA Commissioner Robert Califf highlighted the agency's multilayered plan to fight opioid addiction in conjunction with HHS on Thursday. Via a Twitter thread, he outlined the ways that FDA supports HHS' Overdose Prevention Strategy, including a new proposed rule that would require outpatient health care facilities to issue patients receiving opioid pain relievers prepaid mail-back envelopes for their extra pills. Other opioid reduction strategies by FDA include working with the Drug Enforcement Administration to crack down on illicit opioid markets and developing ways for people to dispose of leftover opioids at home. FDA: NONINVASIVE PRENATAL TESTS MAY HAVE FALSE RESULTS — The Food and Drug Administration cautioned patients and health care providers Tuesday that there's a risk of false results from genetic noninvasive prenatal screening tests, David reports. "The accuracy and performance of NIPS tests have not been evaluated by the FDA and these tests can give false results, such as reporting a genetic abnormality when the fetus does not actually have one," the FDA said in the safety communication. "The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy," the agency added. In Congress HELP COMMITTEE TEES UP USER FEE HEARING WITH FDA OFFICIALS — The Senate Health Committee will hold a hearing on FDA user fee agreements on Tuesday morning. CDER Director Patrizia Cavazzoni, CBER Director Peter Marks and CDRH Director Jeff Shuren are set to testify. Pharma Moves Rachael Fleurence is now a senior adviser to science adviser to the president Francis Collins at the White House. AgencyIQ Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA floats mail-back envelope requirement for outpatient opioids — As part of ongoing efforts to curb nonmedical use of prescription opioids, the FDA this week announced it is seeking input on a proposal to require that all outpatient opioids be dispensed with educational materials and a mail-back envelope for unused medicines. FDA said the approach is already used by some entities. "There are multiple companies that operate DEA-registered mail-back programs and have mail-back envelopes commercially available, which could be utilized by drug manufacturers who would be subject to the potential REMS requirement described in this notice," it wrote in a Federal Register notice. The proposal is related to the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which gave FDA new authorities, including the ability to require Risk Evaluation and Mitigation Strategies for safe disposal packaging, or a safe disposal system for opioids. Pharma in the States New York Mayor Eric Adams wouldn't commit to spending part of the city's $256.4 million opioid settlement on expanding overdose prevention centers, POLITICO's Amanda Eisenberg reports. Most states reported a drop in kindergarten vaccination rates, POLITICO's Krista Mahr reports. Document Drawer FDA published its 2020 report on drug and biologic manufacturers' performance for their postmarketing requirements. FDA issued updated guidance for industry on Thursday that outlines the criteria it intends to use to decide if a 510(k) submission meets "a minimum threshold of acceptability" for review. FDA published guidance on Thursday outlining recommendations for firms developing drugs that contain nanomaterial.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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