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STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy
A panel of advisers to the Food and Drug Administration gave its endorsement Thursday to a seasonal mRNA flu vaccine that was developed by Moderna and that earlier this year became the subject of controversy when a top agency official briefly refused to even consider accepting it for review.
The Vaccines and Related Biological Products Advisory Committee — known as VRBPAC — voted unanimously that the benefits of the vaccine outweigh the risks for both adults aged 50 to 64, and those 65 and older. It remains to be seen what the FDA will decide, but staff presentations during the meeting suggested the agency sees the vaccine as having cleared sufficient hurdles to be licensed via a traditional pathway for the younger group, and an accelerated pathway for the older group.
Multiple flu vaccines currently on the market were first licensed using an accelerated pathway, Wellington Sun, a former FDA employee, noted during the meeting’s public comment period. (After leaving FDA, Sun worked for Moderna, but he is no longer with the company.)
A panel of advisers to the Food and Drug Administration gave its endorsement Thursday to a seasonal mRNA flu vaccine that was developed by Moderna and that earlier this year became the subject of controversy when a top agency official briefly refused to even consider accepting it for review.
The Vaccines and Related Biological Products Advisory Committee — known as VRBPAC — voted unanimously that the benefits of the vaccine outweigh the risks for both adults aged 50 to 64, and those 65 and older. It remains to be seen what the FDA will decide, but staff presentations during the meeting suggested the agency sees the vaccine as having cleared sufficient hurdles to be licensed via a traditional pathway for the younger group, and an accelerated pathway for the older group.
Multiple flu vaccines currently on the market were first licensed using an accelerated pathway, Wellington Sun, a former FDA employee, noted during the meeting’s public comment period. (After leaving FDA, Sun worked for Moderna, but he is no longer with the company.)
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STAT+: CMS recalculates Medicare Advantage star ratings again, adding more volatility to program
Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.
Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.
Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020.
Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.
Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.
Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020.
The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
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New hope in treating Huntington’s disease and a report card on RFK Jr.’s promises
On this week’s episode of “The Readout LOUD”: New hope for people living with Huntington’s disease, and a report card on RFK Jr.’s effort to remake health in America.
The Food and Drug Administration reversed its opposition to a closely watched gene therapy for Huntington’s disease, clearing a path for its maker, the biotech company UniQure, to file for U.S. approval. Joining us to discuss this new development and what it means for the Huntington’s community is Lauren Holder, a Huntington’s disease advocate who is living with the early stages of the disease.
On this week’s episode of “The Readout LOUD”: New hope for people living with Huntington’s disease, and a report card on RFK Jr.’s effort to remake health in America.
The Food and Drug Administration reversed its opposition to a closely watched gene therapy for Huntington’s disease, clearing a path for its maker, the biotech company UniQure, to file for U.S. approval. Joining us to discuss this new development and what it means for the Huntington’s community is Lauren Holder, a Huntington’s disease advocate who is living with the early stages of the disease.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
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STAT+: CMS recalculates Medicare Advantage star ratings again, adding more volatility to program
STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy
Moderna flu vaccine wins unanimous support from FDA panel
New hope in treating Huntington’s disease and a report card on RFK Jr.’s promises
Impact of Early Life Adversity on Epigenome at Molecular Level Mapped in Macaques
Ebola cases increase almost 40% in a week as death toll passes 200
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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