With the help of Krista Mahr
– FDA moves dates for advisers to meet on Moderna, Pfizer-BioNTech pediatric vaccines for Covid-19.
– Senate health officials prepare to formally file their user fee bill from the FDA from this week.
– FDA appoints CDC’s Brian King as the head of tobacco regulation.
It’s Tuesday. Welcome back to Prescription pulse. One of your morning hosts had to familiarize themselves with CDC food safety guidelines after Sunday night’s massive power outage in Virginia.
PFIZER REVEALS KID COVID VACCINE DATA — Pfizer and BioNTech released initial results on Monday showing that three pediatric doses of their Covid-19 vaccine generated an immune response in children aged 6 months to under 5 years comparable to that of two full doses in young adults – a diet that appears to reduce cases of symptomatic disease by 80.3% within the age group, writes Katherine.
The impressive efficacy figure raises questions about how the FDA and its advisers will rule on Moderna’s pediatric offering, which generated comparable immunity in children ages 6 months to under 6 years old compared to younger people adults, but has shown efficacy rates against symptomatic disease of less than 50%. However, Moderna may have more recent efficacy data to present to advisers next month. And Pfizer and BioNTech plan to reevaluate the effectiveness once 21 children in the study develop Covid after their third injection. So far, only 10 out of 1,678 children have studied came down with Covid after their last dose of vaccine.
FDA INCREASES ADVISORY BOARD DATES — The FDA announced on Monday that it will move the dates for meetings of its advisory committee on Covid-19 vaccines for children – June 14 for Moderna’s EUA application for children ages 6 months to 17 years, and June 15 June for Moderna and Pfizer applications for children under 6 months and under 5 years of age, respectively.
The pairing of requests from the youngest of Moderna and Pfizer in one meeting has prompted outcries from parent advocates who have accused regulators of sitting on Moderna’s request to wait for Pfizer, which is expected to submit updated data to the FDA this week.
FDA Commissioner Robert Califf and CBER Director Peter Marks “both publicly deny that the FDA is waiting on Pfizer and say they are working on Moderna’s submission as quickly as possible,” the research group said. Protect Their Future base in a statement. . “Today’s news from the FDA does not appear to be consistent with these statements.”
Doctors speak: Two pediatric medical experts weighed in on optics with Lauren.
“You want the FDA to take time” to review each manufacturer’s application, said Paul Offit of Children’s Hospital of Philadelphia, a member of the FDA’s Vaccine Advisory Committee. “You want the FDA not to trust what they just received.” The pediatrician was referring to the FDA’s practice of independently reviewing each candidate’s data to ensure that their safety, immunogenicity and efficacy results are supported by the calculations they submit. to regulators.
Matt Harris, a pediatric emergency physician at Northwell Health, pointed to criticism of the FDA for not holding an advisory committee meeting before updating its recall recommendations for adults 50 and older as a factor that could influence the agency’s approach to pediatric vaccines. “Part of what gives parents and doctors confidence is that vaccines are not rushed; that they are thoroughly vetted,” he said.
SENATE PLANS TO OFFICIALLY INTRODUCE UFA BILL THIS WEEK — Senate HELP Committee leaders aim to formally introduce their bill this week to reauthorize FDA user fee programs, an aide to the GOP Senate HELP Committee confirmed to POLITICO.
The legislation – which lawmakers could table as early as Wednesday – will show how the package has evolved since it was launched as a bill last week and whether the so-called super runners are still on board, according to a source close to the negotiations in Classes. .
A manager’s package at committee markup – targeted for June 8 – will likely be the source of more substantive changes to the legislative package.
PEW: A MORE VALID ACT NEEDED — The Pew Charitable Trusts and the American Clinical Laboratory Association are among several groups lobbying Senate lawmakers to make changes to the VALID version of the law in the user fee package. Both groups want lawmakers to ensure that the FDA has sufficient funds to develop and implement the regulatory overhaul for laboratory tests and in vitro diagnostics.
But while ACLA wants a third-party review program and more flexibility for labs that modify grandfathered tests before requiring premarket review, Pew wants the FDA to be empowered to perform a adequate post-market surveillance that protects public health.
CALIFF RETURNS TO CAPITOL HILL ON INFANT FORMULA — The FDA commissioner will return to the Hill this week for a fresh round of questions about the agency’s handling of the infant formula shortage.
He will testify before the House Energy and Commerce Oversight Subcommittee on Wednesday alongside the FDA’s two top food regulators, Frank Yiannas and Susan Mayne. Representatives from three of the major formula makers in the United States, including Abbott, will also appear.
Califf will head to the Senate side Thursday, appearing before the Senate HELP Committee on the matter.
CDC VETERAN TO LEAD TOBACCO REGULATION AT FDA — Brian King, deputy director of research translation in the Office of Tobacco and Health at the Centers for Disease Control and Prevention, will take over as director of the Center for Tobacco Products, the FDA announced Friday. King will likely lead the CTP as the bureau grapples with several major tobacco regulations.
Electronic cigarettes : This month, the agency said it does not expect to complete the review of vaping products with major market share until June 30, 2023. On Friday, 11 Democratic senators wrote a letter to the FDA urging the agency to withdraw these products from the market while evaluating their applications.
Menthol cigarettes and flavored cigars: The CTP released proposed rules that would ban menthol cigarettes and flavored cigars in April. The CTP is hosting two listening sessions to discuss any unintended results of these rules on June 13 and 15.
Reducing nicotine levels in cigarettes: FDA Commissioner Robert Califf has hinted that the agency is still considering ways to reduce nicotine levels in cigarettes.
Reactions: Public health experts focused on ending youth vaping applaud the FDA’s decision. “King has studied the epidemiology of what happened, including the extent of the e-cig epidemic among young people. …Expertise is different from bias. He brings his expertise,” said Matt Myers, president of the Campaign for Tobacco-Free Kids, told Katherine.
Vaping advocates fear King is eliminating potentially safer options for adults wanting to quit smoking. “As cigarette sales rise for the first time in 20 years, the choice of an inexorable prohibitionist sends the message that ideology is more important than results,” said Amanda Wheeler, president of American Vapor Manufacturers. Association, in a press release.
MONKEYPOX MESSENGER QUANDARY — On Monday, President Joe Biden backtracked on his monkeypox risk assessment, telling reporters in Tokyo that the rapidly spreading virus across Europe “does not reach the level of concern” of Covid-19 and that the United States has the vaccines to treat the disease.
A case of monkeypox has been confirmed by the Massachusetts Centers for Disease Control and Prevention, and the agency is evaluating at least four more likely cases in New York, Florida and Utah. The FDA has approved two vaccines for the virus, and some 100 million doses of one vaccine are in national stockpile today, according to the CDC.
“I don’t think there’s a great risk to the general monkeypox community right now in the United States,” Capt. Jennifer McQuiston, deputy director of the CDC’s Division of High-Consequence Pathogens and Pathologies, said Monday. .
DRUG MANUFACTURERS OFTEN REFORMULATE BLOCKBUSTER DRUGS – In a paper published on Friday, researchers found that drug companies were more likely to reformulate drugs making $1 billion or more than drugs that reached fewer people or already had generic versions. Reformulating drugs — like making extended-release or combination capsules — allows companies to retain their exclusive rights to sell them.
Lead author Ravi Gupta, a physician and health policy researcher at the National Clinician Scholars Program at the University of Pennsylvania, said the study revealed some ways companies are keeping drugs priced high. “I prescribe extended-release versions that are combination pills for patients all the time, thinking they’ll help patients stick to their medications,” he told Katherine. But if these pills are less accessible than regular generics, it may not make sense to prescribe them, he added.
The FDA on Monday released two draft guidelines containing guidance on when the FDA will not seek regulatory action against blood establishments that fail to meet donor eligibility and suitability requirements and outlining requirements for determine donor suitability. It also released final guidance with recommendations to reduce the risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease.