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CDC eyes narrower COVID-19 vaccine guidance ahead of 2025–2026 season

15 April 2025 at 09:23

The Centers for Disease Control and Prevention's (CDC’s) vaccine advisory committee will meet on Tuesday for a two-day session to lay out new recommendations, including a proposal to scale back current COVID-19 vaccine guidelines.

Dr. Lakshmi Panagiotakopoulos of the CDC is expected to present guidance on COVID-19 vaccine use for 2025–2026 and suggest the department adopt a "narrow" recommendation for it, "and only maintain this series for certain populations within these groups who we determine should be vaccinated."

When polled on April 3, a majority of advisors – 76% – expressed support for a risk-based, rather than universal, COVID-19 vaccination recommendation for the 2025–2026 schedule, up 10% higher from February polling.

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The 70-page presentation outlines three possible policy options for COVID-19 vaccines, including a shift away from recommending annual shots for everyone over 6 months old.

Currently, annual COVID-19 shots are recommended for ages 6 months and older. One proposed policy option would continue the current universal policy, while another would recommend vaccines only for people at higher risk of severe illness, such as older adults, those with underlying health conditions, pregnant women and healthcare workers. 

A third option would blend the two, keeping universal recommendations for people 65 and older but limiting shots for younger groups to those at higher risk.

"When initially presented with 2025–2026 COVID-19 vaccine policy options in November 2024, the Work Group appreciated pros and cons of both risk-based and universal vaccine recommendations," Panagiotakopoulos wrote. "At that time, there was not yet a consensus on what the recommendation for the 2025–2026 COVID-19 vaccine should be. The Work Group requested additional information to help inform the decision-making process on risk-factors for severe COVID-19, transmission and immunity, vaccine implementation and access, and cost-effectiveness."

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The presentation will also propose how to define "increased risk," looking at both health factors and increased exposure, like living in long-term care facilities or working in high-contact jobs.

The two-day meeting of the Advisory Committee on Immunization Practices will examine information for members to vote on as official recommendations, which will then be passed on to the CDC for consideration in June.

The end of the presentation will include discussion questions about the pros and cons of a universal vs. risk-based COVID-19 vaccine recommendation for 2025 to 2026. Key discussion points include whether any groups should be excluded from vaccination, what data is still needed to guide decisions, and whether a risk-based approach makes sense if most people are already considered "at risk."

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According to the CDC, the vaccine committee's agenda will also include a session about the measles outbreak and an update "on literature related to reduced number of doses for HPV vaccine."

Members of the committee will vote on Wednesday on recommendations for the Meningococcal Vaccines, Meningococcal Vaccines VFC, RSV Adult and the Chikungunya Vaccines.

The meeting comes as Health and Human Services Secretary Robert F. Kennedy Jr. is overseeing a major reorganization of the CDC. Plans include transferring non-infectious disease-related divisions to the Administration for a Healthy America to focus on chronic disease management. This move follows significant downsizing under President Donald Trump's directive, which has already reduced the CDC workforce by roughly 4,000 people.

FDA phasing out some animal testing in 'win-win' for ethics and public health: commissioner

10 April 2025 at 11:12

FIRST ON FOX — The Food and Drug Administration is phasing out an animal testing requirement for antibody therapies and other drugs in favor of testing on materials that mimic human organs, the FDA announced on Thursday. 

"For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use," FDA Commissioner Martin A. Makary, said in comment provided to Fox News Digital. 

 "By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics." 

Dogs, rats and fish were the primary animals to face testing ahead of Thursday's announcement, Fox Digital learned. 

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The phase-out focuses on ending animal testing in regard to researching monoclonal antibody therapies, which are lab-made proteins meant to stimulate the immune system to fight diseases such as cancer, as well as other drugs, according to the press release. 

Instead, the FDA will encourage testing on "organoids," which are artificially grown masses of cells, according to the FDA's press release obtained by Fox Digital. 

MULTIMILLION-DOLLAR BIDEN-ERA COVID-19 VAX PROJECT HALTED BY TRUMP’S HHS

"The FDA will promote the use of lab-grown human ‘organoids' and organ-on-a-chip systems that mimic human organs – such as liver, heart, and immune organs – to test drug safety. These experiments can reveal toxic effects that could easily go undetected in animals, providing a more direct window into human responses," the press release says. 

The FDA will also encourage the use of AI while testing drugs, including building computer modeling that can predict a drug’s behavior, Fox Digital learned. 

The phase-out will include updating its guidelines to recognize research conducted on organoids and through AI.

"Companies that submit strong safety data from non-animal tests may receive streamlined review, as the need for certain animal studies is eliminated, which would incentivize investment in modernized testing platforms," the FDA explained in its press release. 

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The FDA is slated to also work with fellow federal agencies, such as the National Institutes of Health, the National Toxicology Program and the Department of Veterans Affairs, to "accelerate the validation" of the new testing standards and will hold a public workshop later this year to further discuss the matter. 

"For patients, it means a more efficient pipeline for novel treatments. It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root," Makary said. 

Federal judge blocks Biden nursing home staffing mandate

9 April 2025 at 06:38

A federal judge in Texas threw out a national mandate on nursing home staffing from the Biden era. 

On Monday, U.S. District Judge Matthew J. Kacsmaryk sided with nursing homes regarding a rule that would have required them to add nurses to meet minimum staffing to patient ratios.

"The agency lacks authority to eliminate consideration of a facility's nursing ‘needs’ when prescribing minimum staffing standards," Kacsmaryk wrote, referring to the Center for Medicare and Medicaid Services.

The plaintiffs, the American Health Care Association (AHCA), represented "approximately 15,000 nursing homes and long term care facilities across the country that provide care to approximately five million people each year," according to a media release. 

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"This unrealistic staffing mandate threatened to close nursing homes and displace vulnerable seniors," Clif Porter, president and CEO of AHCA and the National Center for Assisted Living, said in a statement. "The court decision not only upholds the rule of law and balance of powers, but it protects access to care for our aging population."

Porter is now calling on Congress to act, but says that "federal policymakers should not be dictating staffing hours but encouraging innovation and high-quality outcomes. The staffing mandate is a 20th Century solution that should be blocked by Congress once and for all." 

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In the U.S., "97.8% of nursing homes participate in Medicare and 95.4% participate in Medicaid," Judge Kacsmaryk wrote in the ruling, meaning they must meet a "consolidated set of regulations."

"As we have said from the beginning, nursing homes would love to hire more nurses and caregivers, and despite limited resources, we are doing everything within our power to grow our workforce," AHCA's Porter said in a statement. 

"Even prior to the introduction of the staffing mandate, AHCA was offering federal policymakers a variety of workforce solutions that would help build a pipeline of new caregivers, attract them to long term care, and develop their skills and career," he said. 

RFK Jr talks Kennedy history on first trip as HHS chief, inspires gov to order ‘Mountaineer Mile’ for ‘MAHA'

30 March 2025 at 10:11

Health and Human Services Secretary Robert F. Kennedy Jr. said this week it was fitting he chose Martinsburg, West Virginia, for his first trip to promote the "MAHA" agenda, saying his iconic political family has a unique history in the Mountain State.

Kennedy recalled former New York Democratic Gov. Al Smith – in whose honor a famous annual Catholic Archdiocese-affiliated dinner is held in New York City – and how he incidentally forced the country to reckon with anti-Catholic biases.

Despite being a popular governor in New York who preceded President Franklin Roosevelt in Albany, Kennedy noted Smith’s foray into the presidential arena led to political strife and "a resurgence of the Ku Klux Klan" in parts of the South.

Smith lost to Republican President Herbert Hoover "catastrophically," Kennedy said – as Smith had only won Massachusetts, Rhode Island, five Deep South states and running-mate Sen. Joseph Robinson’s Arkansas.

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"And people all felt, the pundits all felt, that America would never elect a Catholic president," Kennedy said.

So when John F. Kennedy ran for president in 1960, his nephew recalled, the Massachusetts Democrat knew he had to win West Virginia – the state with a then-record-low 2% Catholic population, and where much of the anti-Smith vote in the region during the 1928 cycle came from.

"It was critical for my uncle's campaign that he win this state to show the country that a Catholic could win the presidency," Kennedy said.

"He came down in West Virginia, and his objective was to shake the hands of every person in West Virginia. And I think he came very close."

"And my parents came down; my uncle, my aunts – luckily we have a lot of Kennedys" – he interjected to audience laughter – "and they spent time really getting to know the people of West Virginia and understanding the issues in the state and problems and those things stayed with them throughout his presidency and on Election Day."

JFK ultimately beat Republican Richard Nixon by seven points in the Mountain State, considered a major upset.

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"He always believed that he would not be president if he had not won this state – and he never forgot that relationship; that bond that he had for the people of this state."

Kennedy said that prior to becoming HHS secretary, much of his anti-pollution work took him to West Virginia, particularly coal country in the southern part of the state.

Now, he said, his new role allows him to continue fighting a different type of pollution and "giving people a chance to live healthier lives."

At the event, he and Gov. Patrick Morrisey unveiled a first-in-the-nation policy banning food dyes and certain preservatives in school lunches, with a statewide sunset in 2028.

Morrisey also signed a document seeking a waiver from Kennedy’s office to prohibit SNAP food stamps from being used to buy soda, and instituting work requirements for eligibility.

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"Today we're here to focus on making West Virginia healthy," Morrisey told reporters after Kennedy’s speech.

He went on to unveil an "order" of sorts implementing the "Mountaineer Mile," and added the MAHA (Make America Healthy Again) movement officially began in West Virginia that afternoon.

West Virginia is first in obesity rates, with the nearby District of Columbia considered 51st and therefore the healthiest by that metric. Morrisey said he and Kennedy want to change that.

"We’re cleaning up our foods, promoting exercise, and putting the ‘Nutrition’ back into SNAP," the governor said.

He also instituted the Mountaineer Mile initiative – urging every Mountaineer to walk at least one mile each day. 

To that end, Morrisey posted photos on social media of the sunset view from his own Mountaineer Miles walked near his home in the evenings since.

HHS says it will cut workforce by 10K, saving $1.8B annually

27 March 2025 at 07:21

The U.S. Department of Health and Human Services (HHS) announced that it will lay off about 10,000 full-time employees. 

The move is projected to save taxpayers $1.8 billion annually.

What the department billed as a "dramatic restructuring" comes in response to President Donald Trump's executive order implementing the Republican's "Department of Government Efficiency Workforce Optimization Initiative." 

HHS said it expects a total downsizing of between 82,000 to 62,000 full-time employees when combining this latest effort with early retirement and the results of the Fork in the Road, the deferred resignation offer of full pay and benefits until September. 

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"We aren't just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic," HHS Secretary Robert F. Kennedy, Jr. said in a statement. "This Department will do more – a lot more – at a lower cost to the taxpayer."  

"Over time, bureaucracies like HHS become wasteful and inefficient even when most of their staff are dedicated and competent civil servants," Kennedy added. "This overhaul will be a win-win for taxpayers and for those that HHS serves. That’s the entire American public, because our goal is to Make America Healthy Again." 

Thursday's announcement is intended to streamline the functions of HHS. The department said the 28 divisions of HHS contain "many redundant units," and the restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA. It also will "centralize core functions" such as Human Resources, Information Technology, Procurement, External Affairs, and Policy, the department said. Five of the 10 regional offices will shut down. 

The reorganization of the department is also meant to implement "the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins." 

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The AHA – described as a "new, unified entity" – will encompass the Office of the Assistant Secretary for Health (OASH), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Toxic Substances and Disease Registry (ATSDR), and National Institute for Occupational Safety and Health (NIOSH).

The department said the centralization "will improve coordination of health resources for low-income Americans and will focus on areas including Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development." HHS said transferring SAMHSA to AHA "will increase operational efficiency and assure programs are carried out because it will break down artificial divisions between similar programs." 

The restructuring is also meant to strengthen the Centers for Disease Control and Prevention (CDC). HHS said the Administration for Strategic Preparedness and Response (ASPR), responsible for national disaster and public health emergency response, will transfer to the CDC, "reinforcing its core mission to protect Americans from health threats." 

Notably, Trump earlier this week named Susan Monarez, the current acting director of the CDC, to hold that position permanently. Her nomination replaces Trump's original pick for the role, Dr. David Weldon.

HHS said Thursday it will create a new assistant secretary for enforcement to oversee the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeals (OMHA), and Office for Civil Rights (OCR) to "combat waste, fraud, and abuse in federal health programs." The department will also merge the assistant secretary for planning and evaluation (ASPE) with the Agency for Healthcare Research and Quality (AHRQ) to create the Office of Strategy "to enhance research that informs the Secretary’s policies and improves the effectiveness of federal health programs." 

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The department said "critical programs that support older adults and people with disabilities will be integrated into other HHS agencies, including the Administration for Children and Families (ACF), ASPE, and the Centers for Medicare and Medicaid Services (CMS)." HHS said the reorganization will not impact Medicare and Medicaid services.  

Fox News' Kevin Gora contributed to this report.

Senate committee advances nomination of Dr Oz to run Centers for Medicare and Medicaid Services

25 March 2025 at 13:09

The Senate Committee on Finance voted along party lines Tuesday afternoon to advance Dr. Mehmet Oz, President Donald Trump's pick to lead the Centers for Medicare and Medicaid Services, to a full confirmation vote. 

The party-line vote, which saw 14 GOP senators vote in favor of Oz's nomination and 13 Democrats vote against it, follows two hearings by the Senate Finance Committee that probed Oz over his plans for the federal healthcare programs, his views on abortion, potential conflicts of interest in the healthcare industry and more.

"Dr. Oz has years of experience as an acclaimed physician and public health advocate. His background makes him uniquely qualified for this role, and there is no doubt that he will work tirelessly to deliver much-needed change at CMS," Sen. Mike Crapo, R-Idaho, the chairman of the committee, said Tuesday. 

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Oz graduated from Harvard University and received medical and business degrees from the University of Pennsylvania. He is a former heart surgeon who saw his fame rise through his appearances on daytime TV and 13 seasons of "The Dr Oz Show."

Oz later transitioned into politics, launching an unsuccessful bid for Pennsylvania’s open Senate seat in 2022. He ultimately lost to John Fetterman, then the state's then-lieutenant governor. 

If confirmed by the full Senate, Oz would be in charge of nearly $1.5 trillion in federal healthcare spending. Medicare, a federal healthcare program for seniors aged 65 and up, currently provides coverage for about 65 million Americans, according to the Center for Medicare Advocacy. Medicaid, which assists people with low incomes, covers roughly 72 million Americans, according to Medicaid.gov.

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Oz's leadership would direct decisions related to how the government covers procedures, hospital stays and medication within the federal healthcare programs, as well as the reimbursement rates at which healthcare providers get paid for their services.

Earlier this month, Trump's pick to lead the NIH and FDA, Dr. Jay Bhattacharya and Dr. Marty Makary, respectively, were also approved in committee and are awaiting full confirmation votes in the Senate scheduled for later today. It is unclear when Oz's full Senate vote will take place.

Around the same time that Bhattacharya and Makary won committee approval, Trump withdrew his nomination of former Florida Rep. David Weldon to run the CDC, over fears he did not have the GOP support to clear full confirmation. On Monday, the Trump administration named Susan Monarez, acting director of the CDC, as its new nominee.

Senate committee to vote on Dr. Oz's nomination to run the Centers for Medicare and Medicaid Services

25 March 2025 at 07:06

The Senate Committee on Finance is set to vote later Tuesday afternoon on whether to advance President Donald Trump's pick to lead the Centers for Medicare and Medicaid Services, Dr. Mehmet Oz, to a full Senate confirmation vote. 

The vote follows two hearings by the committee that probed Oz over his plans for the federal healthcare programs, his views on abortion, potential conflicts of interest in the healthcare industry and more.   

If confirmed, Oz would be in charge of nearly $1.5 trillion in federal healthcare spending. Medicare, a federal healthcare program for seniors aged 65 and up, currently provides coverage for about 65 million Americans, according to the Center for Medicare Advocacy. Medicaid, which assists people with low incomes, covers roughly 72 million Americans, according to Medicaid.gov.

HAWLEY SKEPTICAL OF TRUMP PICK OZ: ‘I HOPE HE’S CHANGED HIS VIEWS'

A former heart surgeon who saw his fame rise through his appearances on daytime TV and 13 seasons of "The Dr Oz Show," Oz later transitioned into politics, launching an unsuccessful bid for Pennsylvania’s open Senate seat in 2022. He ultimately lost to John Fetterman, then the state's lieutenant governor. 

Oz graduated from Harvard and received medical and business degrees from the University of Pennsylvania.

As the administrator of CMS, Oz would make decisions related to how the government covers procedures, hospital stays and medication within the federal healthcare programs, as well as the reimbursement rates at which healthcare providers get paid for their services.

DR. OZ BATS BACK DEMOCRATIC ATTEMPTS TO PAINT HIM AS A ‘SNAKE OIL’ SALESMAN IN SENATE HEARING

Earlier this month, Trump's pick to lead the NIH and FDA, Dr. Jay Bhattacharya and Dr. Marty Makary, respectively, were also approved in committee and are awaiting full confirmation votes in the Senate. 

Around the same time that Bhattacharya and Makary won committee approval, Trump withdrew his nomination of former Florida Rep. David Weldon to run the CDC, over fears he did not have the GOP support to clear full confirmation. 

On Monday, the Trump administration named Susan Monarez, acting director of the CDC, as its new nominee.

Trump rescinds Biden-era policy declaring DEI an 'integral' part of scientific process

20 March 2025 at 09:55

FIRST ON FOX: As part of the Trump administration's efforts to peel back Biden-era diversity, equity and inclusion (DEI) requirements, the National Institutes of Health (NIH) rescinded the agency's "Scientific Integrity Policy" implemented under former President Joe Biden.

A "Final Scientific Integrity Policy" was unveiled by the Biden administration during the last few weeks of its term. The policy posited that DEI was an "integral" part of "the entire scientific process," and pushed NIH's chief scientist and top scientific integrity official to "promote agency efforts regarding diversity, equity and inclusion." It also instituted agency-wide policy directives ordering supervisors at the NIH to "support" scientists and researchers who are "asexual" or "intersex," while imploring NIH leadership to "confer with relevant offices" when additional DEI expertise is needed.  

In addition to the amended scientific integrity policy, the Biden administration also took other steps to infuse DEI into the scientific process throughout its term. This included compelling scientists seeking to work with the NIH to submit statements expressing their commitment to DEI, including when seeking certain grant funding for research projects.

"The Biden administration weaponized NIH’s scientific integrity policy to inject harmful DEI and gender ideology into research," said Health and Human Services Department spokesperson, Andrew Nixon. "Rescinding this [scientific integrity] policy will allow NIH to restore science to its golden standard and protect the integrity of science."      

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According to an HHS source, during the Biden administration, a member of NIH's DEI office was placed on every search committee for scientists and leadership. The source also noted that under Biden, scientists who submitted work to the NIH's "Board of Scientific Counselors," which oversees agency research, were also required to include a statement pledging their commitment to DEI. 

The Biden administration also funded grants related to DEI, such as one for roughly $165,000 that was focused on "queering the curriculum" for family medicine doctors to guide them in their treatment of transgender patients. A similar project sought to use taxpayer funds from NIH to instruct nurses on the standards of care from the World Professional Association of Transgender Health (WPATH). 

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WPATH's standards of care for transgender patients, which support the use of puberty blockers, hormone therapy and gender-reassignment surgery for minors, have been rebuked globally. One controversial part of WPATH's guidelines is the inclusion of "enuch" as a valid gender-identity. Several European countries, such as the U.K., Sweden and Finland, have taken steps to steer clear of the treatment modalities suggested by WPATH.

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Under Biden, the NIH also brought DEI activist Ibram Kendi to speak with more than 1,200 staff members about "anti-racism." In a recap of the 2022 speech, the NIH pointed out how Kendi "states unequivocally" that "policies are either racist or antiracist."

The Trump administration's move to rescind the Biden-era scientific integrity policy follows other actions taken to extinguish DEI programs from the public and private sectors, calling such initiatives a civil rights violation.

In addition to slashing DEI programs at the NIH, Trump has also moved to slim down its workforce. Shortly after he took office, the president implemented a funding cap for facilities and administrative fees associated with NIH research to help clear room for additional projects. 

Nobel laureates criticize RFK Jr. HHS nomination over 'lack of credentials,' vaccine stance

10 December 2024 at 05:13

Seventy-seven Nobel Prize winners have come out against the nomination of environmental and health activist Robert F. Kennedy Jr. to lead the Department of Health and Human Services.

In a letter first reported by the New York Times, the Nobel Laureates urge members of the United States Senate to reject RFK Jr.'s nomination, raising concerns about his "lack of credentials" in health science or administration, opposition to vaccines and promotion of "conspiracy theories" about mainstream medical treatments.  

"Placing Mr. Kennedy in charge of DHHS would put the public’s health in jeopardy and undermine America’s global leadership in the health sciences," the letter cautions.

Kennedy, the son of former U.S. Attorney General Robert F. Kennedy, is an environmental lawyer and activist who founded the Children's Health Defense, a nonprofit group accused of spreading misinformation on vaccines, including debunked claims that vaccination causes autism. President-elect Trump declared his intention to nominate Kennedy to lead HHS in November after Kennedy, who ran for president as an independent, endorsed Trump for president.  

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The letter cites Kennedy's opposition to widely-accepted public health interventions, including vaccination and the fluoridation of drinking water, to suggest his confirmation could lead to public harm. The Nobel Laureates also allude to his rejection of scientific evidence that shows H.I.V. causes AIDS. 

Additionally, the Nobel Laureates call Kennedy a "belligerent critic" of the agencies he would oversee as Health Secretary, including the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.

Kennedy has accused the FDA of "corruption" and called for "entire departments" at the agency to be cleared out. He has also called the CDC's vaccine division a "fascist enterprise" and accused health agencies of being captured by the pharmaceutical industry, according to NBC News.  

The Nobel Laureates insist the next health secretary "should continue to nurture and improve — not to threaten — these important and highly respected institutions and their employees." 

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The Trump transition team did not immediately respond to a request for comment.

If confirmed, Kennedy would oversee a vast health policy bureaucracy that includes 13 agencies, operates with a $2 trillion budget and administers Medicare, Medicaid, the Affordable Care Act and other crucial federal health programs. 

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The Department of Health and Human Services guides public health policy for disease treatment and prevention; provides grants for medical research and community health programs; assists with child welfare programs, including adoption, foster care, child care and child abuse; develops bioterrorism defense strategies; resettles refugees who seek asylum in the United States and much more.

"President Trump has asked me to do three things: 1. Clean up the corruption in our government health agencies. 2. Return those agencies to their rich tradition of gold-standard, evidence-based science. 3. Make America Healthy Again by ending the chronic disease epidemic," Kennedy posted on X after his nomination.

Kennedy is not the only recent HHS nominee to face public scrutiny over his apparent lack of health credentials. Conservative groups opposed President Biden's 2020 nomination of then-California Attorney General Xavier Becerra to lead the department on grounds that Becerra, a former congressman and lawyer, had no related health experience. 

The Senate confirmed Becerra 50-49, with the support of all Democrats and just one Republican, Sen. Susan Collins, R-Maine. 

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