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.
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