Health Care
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Health Care
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Moderna’s mRNA flu shot to get FDA review |
After some initial back-and-forth, Moderna’s candidate for a mRNA flu vaccine will get a review by a Food and Drug Administration (FDA) advisory panel next month.
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© AP Photo/Bill Sikes, File
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The panel will meet June 18 to discuss and make recommendations on the safety and effectiveness of Moderna’s MFLUSIVA flu vaccine, according to a Federal Register notice published Thursday. The FDA is set to make a decision by Aug. 5, in time for the next flu season.
The FDA initially refused to review the vaccine in February before abruptly reversing course a week later.
This decision comes following the abrupt departure of former FDA Commissioner Marty Makary and not long after the departure of Vinay Prasad, the controversial former top vaccine regulator.
While in office, Makary publicly spoke of faster, more flexible reviews, but companies did not see that play out in practice.
It was Prasad who initially rejected Moderna’s application due to what he said were research design flaws. Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Health and Human Services Secretary Robert F. Kennedy Jr.
Moderna spent years and hundreds of millions of dollars developing the vaccine, and the agency’s refusal to even consider the application drew sharp criticism from the company, Wall Street and the biotech industry.
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Welcome to The Hill’s Health Care newsletter, we’re Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health.
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How policy will be impacting the health care sector this week and beyond:
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World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus warned Friday that “violence and insecurity” have hampered the response to the Ebola outbreak in Congo, which he called “deeply worrisome.” Fires erupted at an Ebola treatment center in Rwampara after people were stopped from retrieving a local man’s body, The Associated Press reported. Bodies infected with Ebola can be …
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The head of the White House task force for the upcoming World Cup said Friday that Congo’s national soccer team must remain in isolation for 21 days if it plans to enter the U.S. amid an ongoing Ebola outbreak, according to ESPN. Andrew Giuliani, the son of former New York City Mayor Rudy Giuliani, told the network that the U.S. has informed FIFA, the Congolese team and the African nation’s government that players …
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Dr. Neil Vora, an epidemiologist, warned that the spread of the Ebola virus in several African countries “will get worse before it gets better.” Vora, who worked for the Centers for Disease Control and Prevention (CDC) during Congo's 2019 Ebola outbreak, called this recent spread “a very serious situation” during an interview on NewsNation‘s “Elizabeth Vargas Reports" ...
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Your care shouldn’t be put on hold |
When insurers delay approvals or require endless paperwork, patients are left waiting for care they need now. Addressing harmful corporate insurer practices can help ensure timely access to treatment and protect 24/7 care. Learn more
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Branch out with a different read from The Hill:
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The Trump administration on Friday announced prospective immigrants would need to return to their home country to apply for green cards, a move that would stifle the most common pathway used for legal immigration. U.S. Citizenship and Immigration Services (USCIS) portrayed the new policy memo as “returning to the original intent of the law,” while immigration advocates said the change was a cruel and disruptive move targeting those in the country legally ...
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Local and state headlines on health care:
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- Feds greenlight Wyoming’s plan to spend $205M on healthcare initiatives (WyoFile)
- Delaware healthcare spending explodes yet again (Spotlight Delaware)
- PacificSource to end Montana insurance operations (Daily Montanan)
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Health news we’sve flagged from other outlets:
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- Relief group is phasing out vaccines RFK Jr. believes are unsafe (Politico)
- Health experts ‘stunned’ by Trump officials’ strict quarantine measures (The New York Times)
- Congress slashed Medicaid funding to providers. The Trump administration wants to cut even further (Stat)
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Opinions related to health submitted to The Hill:
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You’re all caught up. See you next week!
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