| by Max Bayer | |||
| The FDA on Wednesday approved updated formulas of the Covid-19 vaccines ahead of the fall respiratory season, though the labels are more limited than in years past.
Vaccines were approved for Pfizer, Moderna and Novavax for all adults 65 and older and people younger than 65 who are at higher risk of severe disease. Moderna’s Spikevax will be the only shot available for at-risk children 6 months to 5 years old after the FDA pulled Pfizer’s emergency use authorization for Comirnaty in that age range. Pfizer has yet to ask for approval for the youngest kids, so its approval label applies to people five years and older. Novavax’s vaccine was approved for kids and adults 12 and older. HHS Secretary Robert F. Kennedy Jr. announced the approvals in a post on X. from AXIOS:
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from STAT:policyFDA approves updated Covid shots, with changesThe FDA approved updated Covid boosters yesterday, but also removed emergency use authorizations for the vaccines, STAT’s Lizzy Lawrence and Matt Herper report. It’s a set of moves that could make the shots more difficult to obtain for children under 5 in particular. The American Academy of Pediatrics called the restrictions “deeply troubling.”In a post on X, health secretary Robert F. Kennedy Jr. said that the Moderna vaccine is approved for those older than 6 months, the Pfizer/BioNTech vaccine for those older than 5 years, and the Novavax shot for those older than 12. The FDA approved Moderna’s vaccine for children as young as 6 months in July, but only for those with an underlying condition. Pfizer’s shot, which was previously available to children as young as 6 months via the emergency use authorization, had been seen as the main option for parents wishing to inoculate their young, healthy children against Covid. Read more. obesityNovo wants to develop self-replicating RNA obesity drugsFrom my colleague Elaine Chen: Novo Nordisk will be partnering with Replicate Bioscience to develop self-replicating (srRNA) candidates for obesity, type 2 diabetes, and other cardiometabolic conditions, according to an announcement this morning.Under the deal, Novo will get an exclusive license to develop and commercialize the lead programs using Replicate’s srRNA platform. Meanwhile, Replicate will receive research funding and up to $550 million in an up-front payment and potential milestone payments. The biotech is also eligible to receive royalties on future drug sales.Self-replicating RNA is a type of messenger RNA that can make copies of itself, with the hope of achieving longer therapeutic effects.Novo has, for awhile, been researching how to develop longer-lasting obesity therapies — for example, using RNA interference (RNAi) technology.
| Photo illustration: Brendan Lynch. Photos: Getty Images | |||
The CDC was engulfed in turmoil late last night when HHS announced that director Susan Monarez had abruptly departed — only to be contradicted by her lawyers, Axios’ Tina Reed writes.
Why it matters: The dispute left CDC leadership in limbo as a wave of high-level departures gutted the top ranks of the agency responsible for protecting the nation’s public health. After HHS announced that Monarez is “no longer director of the Centers for Disease Control and Prevention,” attorneys Mark Zaid and Abbe Lowell posted on X that Monarez “has neither resigned nor received notification from the White House that she has been fired.”
Share this story … Maya Goldman and Emily Peck contributed.
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| Illustration: Maura Losch/Axios | |||
| The process for settling disputes under the federal surprise billing ban has generated at least $5 billion in costs since its inception in 2022 that will likely be reflected in higher overall health expenses and premiums, researchers wrote in the latest edition of Health Affairs.
The big picture: Multiple legal challenges to arbitration rules have kept providers and insurers at odds almost since the No Surprises Act took effect and swamped a dispute resolution system the law established. What they found: From mid-2022 to May 2025, more than 3.3 million disputes were filed. That’s in stark contrast to original estimates that the process would handle about 17,000 disputes annually, and that most would be resolved amicably through a mandatory 30-day negotiation period.
The researchers estimated the dispute resolution system is adding about $2 billion to $2.5 billion in costs per year. That figure may not capture all of the administrative expenses. |
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policyHHS wants med schools to prioritize nutrition moreBefore he dropped the news on Covid vaccines, Kennedy made another announcement: Along with the Department of Education, HHS is calling for nutrition education requirements to be better incorporated into pre-med qualifications, medical school curriculums, licensing, residency requirements, board certifications, and continuing education for doctors. Medical organizations are being asked to submit written plans with a timeline and accountability measures to HHS by September 8. “One of the things we’re gonna do at NIH is to really give a carrot and stick to medical schools across the country saying you gotta put in your first-year curriculum a really good, robust nutrition course,” Kennedy said in a July video. Yesterday’s announcement didn’t come with details on the carrot or the stick that might be used to incentivize medical schools, but the health secretary has previously said federal funds would be withheld from those that don’t comply. Experts agree that nutrition education is important, which is why this initiative from Kennedy may be “pushing on an open door,” as STAT’s Sarah Todd wrote last month. Re-visit her story on how a greater focus on nutrition has the potential to combat bias against higher-weight patients. |
Zoom in: At least four other top CDC officials — including chief medical officer Dr. Debra Houry — resigned last night, according to internal emails viewed by Axios.
