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Health policy roundup: NIH director explains cancellation of mRNA vaccine contracts


In a podcast appearance, NIH Director Jay Bhattacharya explained the government's decision to cancel nearly $500 million in mRNA vaccine contracts, saying the vaccines are not viable because the public doesn't trust them, in today's roundup of the news in healthcare politics.

Trump issues order to give political appointees control of grantmaking

President Donald Trump last week issued an executive order aiming to change the rules guiding grant decisions, placing grantmaking authority with presidential appointees who are directed to work with the White House to "advance the President's policy priorities."

The order, titled "Improving Oversight of Federal Grantmaking," directs the heads of each agency to designate a senior appointee who will be in charge of creating a process to review grant opportunity announcements and make sure any awarded grants are "consistent with agency priorities and the national interest."

"In short, there is a strong need to strengthen oversight and coordination of, and to streamline, agency grantmaking to address these problems, prevent them from recurring, and ensure greater accountability for use of public funds more broadly," the order says. "The Government holds tax revenue in trust for the American people, and agencies should treat it accordingly."

Experts say the order is likely to be challenged in court and could have a massive impact on American science.

According to a former associate provost for research at a major university who spoke to STAT on condition of anonymity, the order "ends up disrupting a decades-long and very productive partnership or collaboration between the federal government and the research institutions" by making federal agencies less reliable funders. "It's going to be a big deal, and there will be legal challenges to it."

The former provost also said he worries the order's provisions will be more likely to withstand legal challenges than previous attempts by the Trump administration to terminate existing research.

"All these appeals have said that it's arbitrary and capricious for the director of NIH or any other director of an agency to simply take away a grant that's already been lawfully awarded," he said.

The order "turns science into an instrument for partisan gain," said Scott Delaney, a lawyer and Harvard University epidemiologist who's been tracking grant cancelations. "Now we have Republican science and Democrat science. The EO formalizes a system that burrows government censors into the roots of the scientific enterprise."

(Molteni, et al., STAT+ [subscription required], 8/8; Samuels, The Hill, 8/7)

FDA vaccine chief who resigned returns to agency

Vinay Prasad, who formerly led FDA's division that regulates vaccines, gene therapies, and blood products until he resigned in July, is returning to the agency, HHS announced on Saturday.

Prasad resigned in late July following a public campaign led against him by right-wing influencer Laura Loomer and lobbying by former Republican Senator Rick Santorum. Prior to the resignation, Loomer took to social media highlighting Prasad's decisions denying approval of new drugs for rare diseases and highlighting past statements he made in support of prominent left-wing figures, including Sen. Bernie Sanders (I-Vt.).

The resignation came following escalating tensions and criticism for Prasad's crackdown on Sarepta Therapeutics, which came under scrutiny after two teenagers and a 51-year-old man died of liver complications after using Sarepta's gene therapy drugs.

Prasad pressured the company to stop shipping its drug Elevidys for Duchenne muscular dystrophy but then reversed his decision days later for young boys who can still walk and are believed to be at lower risk of complications.

Critics argued that Prasad's actions were tantamount to a crusade against Sarepta, and Santorum, who has ties to Sarepta, called top White House officials to relay his concerns, a person familiar with the matter told the New York Times.

However, on Saturday, Andrew Nixon, a spokesperson for HHS, said that at FDA's request, Prasad "is resuming leadership of the Center for Biologics Evaluation and Research."

Prior to his resignation, both HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary defended Prasad against the mounting attacks. Makary referred to him as an "impeccable scientist" and Kennedy told an associate he wanted Prasad to stay at FDA in part because of his approach to vaccines, people familiar with the matter told the Times.

At an event earlier last week alongside Kennedy, Makary said that he was seeking to bring Prasad back to FDA.

(Jewett, New York Times, 8/9; Associated Press, 8/11)

NIH director says public lack of trust is why mRNA vaccine contracts were canceled

In an appearance on the right-wing podcast "War Room" with Steve Bannon, NIH Director Jay Bhattacharya explained the government's decision to cancel nearly $500 million in mRNA vaccine contracts saying the vaccines are not viable because the public doesn't trust them.

"As far as public health goes, the mRNA platform for vaccines is no longer viable," Bhattacharya said. "You can't have a platform where such a large fraction of the population distrusts the platform, if you're going to use it for vaccines, and expect it to work."

Bhattacharya added that he believes the mRNA vaccine platform is "promising but not yet ready for prime time for vaccines."

Bhattacharya's comments conflict with the rationale offered by HHS Secretary Robert F. Kennedy Jr. for canceling the research contracts.

Earlier this month, Kennedy announced that the Biomedical Advanced Research and Development Authority would be terminating 22 grants totaling nearly $500 million supporting the development of mRNA vaccines. Kennedy argued that "data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu," adding that "one mutation and the vaccine becomes ineffective" which he said encourages "new mutations and actually prolong pandemics."

Bhattacharya confirmed that it was Kennedy's decision to terminate the contracts.

Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy, said that Bhattacharya's comment was "disingenuous."

Kennedy and his allies have argued that mRNA vaccines aren't safe and effective, despite scientific evidence to the contrary, and "that message that they're selling is one of the major reasons why there is potential public reluctance," Osterholm said.

(Branswell, STAT, 8/11)

FDA may revoke emergency authorization allowing young children to get COVID-19 vaccine

According to an email sent by CDC to state and local health departments reviewed by the New York Times, FDA is considering discontinuing the emergency use authorization that allows children under the age of 5 to receive Pfizer's COVID-19 vaccine.

Pfizer confirmed the possibility to the Times and said it was "currently in discussions with the agency on potential paths forward." The email said the Pfizer vaccine is expected to be approved and available for children ages 5 to 11 years old.

In July, FDA granted full approval to Moderna's COVID-19 vaccine for children but only for those with health conditions that could put them at an increased risk of a severe case of the disease. Meanwhile, Novavax's vaccine has never been available for children under the age of 12.

If FDA doesn't renew Pfizer's authorization for children ages 6 months to 4 years or fully approve the vaccine, healthy children in that age group will not have an officially sanctioned COVID-19 vaccine available to them. However, doctors can still choose to provide the vaccine "off label."

The risk of severe COVID-19 and hospitalization for children under the age of 1 is comparable to adults ages 65 and older, the Times reports, which is why experts have said a child's first exposure to the coronavirus should be through a vaccine rather than an infection.

"Unfortunately, this leaves one of the vulnerable groups, specifically healthy children less than 2 years old, without access to a safe vaccine that’s known to prevent hospitalization and death," said Lakshmi Panagiotakopoulos, who oversaw CDC's work group on the COVID-19 vaccine before resigning in June.

"Providers already don't order a lot of COVID vaccine, so this is going to very much complicate things," said Claire Hannan, executive director of the Association of Immunization Managers.

If providers decide not to carry shots of the vaccine, "it's going to be hard to find even if you're high risk," Hannan added.

(Mandavilli, New York Times, 8/11)

Rural health fund applications will open in September

Applications for states to receive a portion of a $50 billion fund aimed at helping rural hospitals manage federal funding cuts will open in early September, according to CMS Director Mehmet Oz.

"The money is designed to help you with workforce development, right-sizing the system and using technology to provide things like telehealth that can change the world," Oz said in an interview.

The rural health fund was included in the One Big Beautiful Bill Act (OBBBA), which was passed by Congress and signed into law in early July, following concerns about deeper Medicaid cuts.

The fund, called the Rural Health Transformation Program, requires states working alongside hospitals and other providers seeking a portion of the fund to explain to federal regulators how they plan to use the money. CMS must approve any applications by Dec. 31.

Critics have argued the $50 billion won't be enough to prevent rural hospitals from closing, with a report from the Cecil G. Sheps Center for Health Services Research finding that OBBBA would cause hundreds of rural hospitals to risk closure or service reductions or end inpatient care.

"It's very clear that Medicaid cuts will result in rural hospital closures," said Alan Morgan, CEO of the National Rural Health Association.

Many rural hospitals operate on very thin, if not negative, margins, and proposed cuts to Medicaid in the bill would further erode hospitals' ability to maintain services and stay open. According to a report from Chartis, a health analytics and consulting firm, Medicaid brings in $12.2 billion or nearly 10% of rural hospital net revenue.

A 15% cut to Medicaid would lead rural hospitals to collectively lose more than $1.8 billion, which is roughly equivalent to 21,000 full-time hospital employees' salaries.

Hospitals that can stay afloat amid cuts would likely do so by cutting services especially dependent on Medicaid reimbursements like labor and delivery units, mental healthcare, and EDs.

(DeSilva, Modern Healthcare, 8/4)


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