Latest news with #AndrewNixon
Boston Globe
3 days ago
- Health
- Boston Globe
mRNA, once lauded as a scientific marvel, is now a government target
Advertisement On Wednesday, the Department of Health and Human Services confirmed it was canceling 'The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public,' HHS communications director Andrew Nixon said of the Moderna contracts. The White House did not respond to STAT's request for comment. Moderna, which built its business on mRNA and Advertisement 'mRNA vaccines funded by Operation Warp Speed were essential to ending the COVID-19 pandemic, preventing an estimated 20 million deaths worldwide, including more than 1 million in the United States,' Moderna told STAT. 'The efficacy and safety profile has been confirmed in over 2.5 billion people.' Pfizer, Moderna's mRNA COVID-19 vaccine rival, also defended the technology. CEO Albert Bourla Ending the Moderna contracts is the latest in a series of events signaling the administration's growing disdain for mRNA and COVID-19 vaccines. The Food and Drug Administration Still, in a partial victory for Moderna, the FDA on Friday Some of the attacks levied at mRNA are about the technology itself, while others stem from general vaccine skepticism and frustrations with vaccine mandates during COVID. But the impact is the same: Waning political support of mRNA is leading to Advertisement 'We were on the right avenue to really enhance our preparedness for the next pandemic, and we literally just killed it,' said Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy. Osterholm has no financial ties to the mRNA industry. There are signs that distrust of mRNA extends beyond COVID shots. After Oracle founder Larry Ellison said the Trump administration's $500 billion investment in AI could lead to personalized mRNA cancer therapies, various anti-vaccine Trump supporters The opposition to mRNA could spook companies and stifle innovation on treatments for a wide range of life-threatening conditions. Novel cancer vaccines, gene-editing therapies, and rare disease medicines rely on mRNA. The cutting-edge CRISPR therapy used to edit out a genetic mutation causing 'What this means is that China is going to take over RNA therapeutics and RNA research and the United States is going to fall behind,' said Drew Weissman, a Billions of doses of mRNA COVID-19 vaccines have been administered worldwide, allowing them to be among the Advertisement Much of the backlash against mRNA shots rests on the false idea that the vaccines can cause long-term organ damage or even alter a person's DNA. However, This belief, combined with more general vaccine skepticism, has a strong champion in Kennedy, who has spread misinformation about mRNA in his books and through the anti-vaccine nonprofit he founded. 'As this book goes to press, the campaign to force unsafe COVID vaccines into children's bodies is reaching its peak,' he wrote in 'The Real Anthony Fauci,' his 2021 book about the former director of the National Institute of Allergy and Infectious Diseases. 'We can jettison this insanity if enough people refuse to participate in a new apartheid based upon forced medical procedures.' Despite evidence to the contrary, Kennedy has asserted in his books that mRNA COVID vaccines killed more people than they saved, and caused more death and injury than they averted in teenagers. Robert F. Kennedy, Jr. speaks after his swearing-in as Secretary of Health and Human Services, in the Oval Office of the White House in Washington on Feb. 13. ERIC LEE/NYT While he tried to distance himself from his past comments in order to be confirmed by the Senate, Kennedy has since made changes to vaccine policy and practice. Colleagues like NIH Director Jay Bhattacharya seem to have suspicions of mRNA, too. Advertisement Last month, Bhattacharya was unenthusiastic about the technology, saying in an interview with Manufacturers and researchers have been trying to address the skepticism of mRNA via But the odds are stacked against them. Kennedy has elevated fellow leaders in the vaccine-critical movement into the nation's consciousness. Longtime confidante Stefanie Spear, now principal deputy chief of staff at HHS, helped Kennedy start a blog that promoted misleading information about vaccines. Children's Health Defense CEO Mary Holland routinely attends Kennedy's events, as does Del Bigtree, who stepped down from the nonprofit group MAHA Action to pursue more vaccine-focused advocacy. Others, like the physician-blogger Peter McCullough — credited by some with kickstarting the anti-COVID-vaccine era — and vaccine injury attorney Aaron Siri, were recently invited by like-minded senators to testify before Congress. In that hearing, they spread vaccine skepticism on a larger platform, arguing that crucial safety information has been kept from the public. Both men have a stake in that idea. Advertisement Siri runs a law firm almost entirely devoted to litigating vaccine injury claims. He and Kennedy previously worked together on such cases. McCullough is a prolific mRNA critic on social media and in his newsletter. He also serves as chief scientific officer of alternative-health care group The Wellness Company, which sells products like an unproven 'Spike Detox' supplement for long COVID, and as head of the McCullough Foundation, which funds a variety of projects by vaccine skeptics. McCullough told STAT he believes mRNA vaccines are not safe, and that his foundation is actively pushing for policies restricting their use. HHS staff and Kennedy reach out to him from time to time, he said. McCullough noted he's been most involved with Idaho's 'We talked to some very senior officials, and they said one of the reasons you need to be here is because of the state activity,' Alspach said. 'They specifically cited Idaho.' By now, the anti-mRNA sentiment has spread far beyond Idaho. Republican lawmakers in Illinois, New York, and Texas, among others, have introduced their own bills targeting mRNA vaccines and, in some cases, the mRNA platform more broadly. Several bills push to ban the technology altogether, while others are designed to change rules for vaccinated blood donors, or impose fines on providers who give mRNA shots. Conservative Most of the bills are unlikely to gain traction; the Texas bill has made it the furthest, with the state senate 'It's kind of breathtaking how the field has shifted and done almost a 180, really,' said Kate Broderick, geneticist and chief innovation officer at mRNA manufacturer Maravai LifeSciences. 'During COVID, there was so much support, and it's really quite frightening, frankly, the pivot that's happened in a relatively short period of time.' Alspach said the political backlash against mRNA is a uniquely American phenomenon. If the US government stops investing in the technology, he said, American patients will rely on research coming out of other countries on mRNA-based gene therapies, cancer treatments, and vaccines. 'This is the only place in the world where this is happening,' Alspach said. 'Other countries are rolling out the red carpet for this technology.' The group has found it difficult to fend off attacks against the technology, as many critiques are vague or wrapped in general resentment about the handling of the COVID pandemic. The word 'mRNA' makes people think about vaccine mandates, school closures, and the theory that COVID originated in a lab, said mRNA researcher Jeff Coller, a co-founder of the Alliance for mRNA Medicines. The mRNA vaccines' association with lingering COVID resentment was on full display at the congressional hearing that featured McCullough and Siri. The hearing, hosted by the Committee on Homeland Security and Government Affairs' investigations subcommittee, was titled, 'The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines.' Subcommittee chairman Sen. Ron Johnson (R-Wis.) and other conservative lawmakers spent several hours rehashing arguments born in the pandemic — against lockdowns, masks, mandates, and more — now with added confidence and new data sources. They cited reports from vaccine-critical groups, and said there was no evidence COVID vaccines saved lives. ( Broderick said so far, his alliance has not had luck reaching anyone in the administration to directly express its concerns. The goal is to ask Kennedy, Bhattacharya, and others questioning the safety of the mRNA platform about their specific worries. 'What we would really love to do is say, can we have a dialogue about that?' Broderick said. 'What can we do together as a scientific community to allay any concerns or provide you with the data to support our standpoint?'
Epoch Times
29-05-2025
- Health
- Epoch Times
Health Department Cancels More Than $700 Million in Funding for Moderna's Bird Flu Vaccine
The Department of Health and Human Services (HHS) has canceled funding for Moderna's vaccine against avian influenza, also known as the bird flu, the department confirmed on May 29. 'After a rigorous review, we concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable,' HHS communications director Andrew Nixon told The Epoch Times via email.
New York Times
15-05-2025
- Health
- New York Times
Federal Officials May Limit Recommendations for Covid Vaccine
Come this fall, only older Americans and those with chronic health problems may be urged to get the Covid shot — assuming the vaccine is available at all. For years now, scientific advisers to the Centers for Disease Control and Prevention have been debating whether to continue to recommend that Americans 6 months of age and older be immunized, or to switch to a so-called risk-based strategy targeting only the most vulnerable, as is the practice now in most other countries. The advisers are expected to decide on a way forward at a meeting in June. But the debate may have become irrelevant. New requirements for clinical testing of vaccines, announced earlier this month, may delay the availability of shots that had formerly been updated annually without complicated trials. 'Substantial updates to existing vaccines — such as those related to seasonal strain changes or antigenic drift — may qualify as 'new products' and therefore require additional clinical evaluation,' the Department of Health and Human Services said in a statement. That category includes the Covid shots and 'may' even include the seasonal flu vaccine, according to Andrew Nixon, a spokesman for H.H.S. The Food and Drug Administration has already asked Novavax for more clinical data before approving its Covid vaccine. (Currently it has emergency use authorization, not full approval, for people aged 12 and older.) 'We want to see vaccines that are available for high-risk individuals, and at the same time we want some good science, we want some good clinical data,' Dr. Marty Makary, who heads the agency, told reporters at a conference on Thursday. Officials in Washington have also been asking pointed questions of C.D.C. scientists about Covid's toll on children under 12, an indication that they may be considering an end to the use of the vaccine in that age group, according to an official who did not wish to be identified for fear of retribution. The Wall Street Journal reported on Thursday that H.H.S. plans to stop recommending the Covid vaccine for children and pregnant women altogether, citing people familiar with the matter. In May 2021, Robert F. Kennedy Jr. sought to rescind authorization for the shots in a petition to the F.D.A. He has said, falsely, that the vaccines had killed more people than the virus. The leaders he has installed at the agencies he leads, including Dr. Makary, have also been outspoken critics of annual Covid shots, particularly for children. On the latter point, many public health experts agree, including some advisers to federal agencies. They have suggested for years now that annual booster shots might offer only marginal benefits to relatively younger, healthy Americans. 'I think what Dr. Makary is saying is that if everybody already has immunity to the virus, then maybe the vaccine doesn't add that much, or maybe it adds something only in certain subpopulations,' said Dr. Philip Krause, a former F.D.A. vaccine regulator. 'I think it's a reasonable question to want to know the answer to.' (Dr. Krause resigned from the F.D.A. in the fall of 2021 because he felt there was not enough evidence to support Covid booster shots for adults.) The C.D.C. already collects data on the benefits of the Covid vaccines, which have decreased over time as more Americans gain greater immunity to the coronavirus. But the vaccine should remain available to some people, including adults 75 and older, who remain at high risk, Dr. Krause and other experts noted. 'In my opinion, the data from the C.D.C. provide pretty strong evidence that there are some people who are still benefiting quite a bit from the vaccines,' he said. 'There are still more Covid deaths than we would like.' Mr. Kennedy has falsely asserted that none of the vaccines routinely offered to children have been tested in placebo clinical trials, prompting sharp rebuttals from several groups of scientists, and from Senator Bill Cassidy, Republican of Louisiana, whose vote cinched Mr. Kennedy's nomination as health secretary earlier this year. Some experts fear that the new federal limits are just the first steps in a campaign to undermine the use of all vaccines, including those in the childhood immunization schedule, by raising doubts about their safety and imposing requirements that make it untenable for companies to keep making them. 'I think that we are in the midst of watching the vaccine infrastructure being torn down bit by bit,' said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and an adviser to the F.D.A. Tara Smith, an epidemiologist at Kent State University College of Public Health who tracks the anti-vaccine movement, said there was jubilation among some groups that all vaccines, including the decades-old flu vaccine, might be challenged. 'I think everything is a target,' she said. Covid fatalities have plummeted each year since the start of the pandemic, although there were still roughly 1,000 deaths per week during last winter's peak. The vast majority occurred among adults aged 75 and older. Earlier this month, federal officials sent the C.D.C. an urgent request for the annual number of Covid-related deaths in children under 12, according to an official with knowledge of the matter. In the year ending in August, the agency reported 150 pediatric deaths, a number comparable to deaths among children in a typical flu season. 'We all, I think, support the pediatric use of flu vaccines,' said Michael Osterholm, an infectious disease expert at the University of Minnesota. If Covid is roughly as risky to children, 'I find it hard not to at least allow the vaccine to be available.' The number of Covid deaths in children seems low only when compared with fatalities in adults, said Sean O'Leary, chair of the infectious disease committee for the American Academy of Pediatrics. 'That's the wrong way to look at it, because pediatric deaths are actually quite rare,' he said. If the vaccine were withdrawn for young children entirely, 'I would have a big problem with that. Those kids do remain at higher risk for hospitalization.' Dr. Krause said he was puzzled that the pediatric vaccine had not been moved to full approval from emergency authorization, while the adult versions were fully approved years ago by the F.D.A. It may be that the F.D.A. has access to data that has prevented them from approving the shot, he said. 'That being said, I think there probably are some children who would benefit from the vaccine,' he said. The F.D.A. has not elaborated on what additional testing of Covid vaccines might entail. But officials may offer some clarity before the agency's scientific advisers meet next week to discuss vaccines for the fall. It would be unethical to offer a placebo to participants in a randomized trial if the virus still poses risks. And the results of any new trials would not be available in time for the fall, experts noted. 'In order to to create new requirements for vaccines, there would have to be evidence that that would have any benefit for the public,' said Dr. Eric Rubin, one of the F.D.A.'s advisers and editor in chief of the New England Journal of Medicine. 'The issue, of course, is when you go into this having decided what the answer is, rather than looking at the data objectively,' he said. Some of the C.D.C.'s advisers had mixed feelings even about moving to risk-based vaccine recommendations. Such guidelines make sense in countries with universal health coverage, they said. But in the United States, insurance companies are not required to pay for an immunization that is not recommended by the C.D.C. That may leave a vaccine that is too expensive for some who need it and are not explicitly included in a risk-based recommendation. A blanket recommendation may be more effective, some experts said. 'Vaccinations for children who have never been vaccinated, people with risk factors, are critically important,' said Dr. Denise Jamieson, one of the C.D.C. advisers. It's unclear whether the advisers retain much sway, however. Recommendations they made in April for use of several vaccines, which are typically promptly accepted by the C.D.C., have still not been endorsed by an agency leader. The C.D.C. does not have a permanent director. Matthew Buzzelli, whom Mr. Kennedy pointed to on Wednesday as an acting director, is an attorney. Another official at H.H.S., Dr. William Archer, has sent the C.D.C. multiple questions about the advisers' recommendations. Dr. Archer has repeatedly discussed the 'limitations' of the Covid vaccine on social media, according to Reuters. In one query viewed by The New York Times, he told agency staff he needed 'more justification' for a recent recommendation to expand use of the respiratory syncytial vaccine.
CBS News
13-05-2025
- Health
- CBS News
Head of worker safety agency NIOSH restored, ahead of RFK Jr. hearing
The head of the National Institute of Occupational Safety and Health and a handful of teams at the agency had their layoff notices rescinded Tuesday, multiple officials say, and several worker safety programs that had been eliminated by layoffs last month are being restored. Letters reversing the layoffs arrived in the inboxes of some NIOSH staff a day ahead of House and Senate hearings Wednesday with Health and Human Services Secretary Robert F. Kennedy Jr. where he was expected to face questions about the layoffs. Health officials and scientists being brought back to work include everyone in NIOSH's respiratory health division, division of safety research, division of compensation and analysis support and National Personal Protective Technology Laboratory according to an email obtained by CBS News. "Secretary Kennedy has been working hard to ensure that the critical functions under NIOSH remain intact. The Trump Administration is committed to supporting coal miners and firefighters, and under the Secretary's leadership, NIOSH's essential services will continue as HHS streamlines its operations," HHS spokesperson Andrew Nixon said in an email. A handful of NIOSH staff working in the agency's World Trade Center Health Program previously had their layoffs reversed, after a second round of cuts at the agency earlier this month. "While we celebrate with those who received a rescission letter from HHS, I am mindful that others did not. I am hopeful that we can continue to make the case for reinstating everyone at NIOSH," the agency's now-reinstated director, Dr. John Howard, wrote in the email. The reinstatements mean that some NIOSH programs might soon be able to resume, after they were previously hobbled by the layoffs. For example, the agency's National Personal Protective Technology Laboratory had been forced to suspend new approvals of equipment like new N95 respirators and protective gear for firefighters after the initial round of cuts on April 1. Investigations of workplace health risks through NIOSH's Health Hazard Evaluation program were also upended by the layoffs, but staff working in those probes have now been reinstated. But many workers also remain effectively laid-off at the wide-ranging agency, which functions as the research and testing counterpart to the Department of Labor's Occupational Safety and Health Administration and Mine Safety and Health Administration. In NIOSH's Spokane and Pittsburgh Mining Research Division, laid-off scientists and engineers were called back to work, but only for a few more weeks to wind down their laboratories and research before their layoff notices take effect. Those NIOSH employees have not received letters formally rescinding their layoffs, unlike some of their colleagues. Part of their work includes overseeing miner safety programs like the personal dust monitors, or PDM, required by the Department of Labor for coal miners. NIOSH is responsible for testing PDM's accuracy. The monitors are needed to reduce the risk of black lung disease. NIOSH had also been in the process of developing similar monitors for miners exposed to silica dust, before the layoffs gutted the teams overseeing that work. Other NIOSH teams like the Health Effects Laboratory Division were also not listed among the reinstatements. Other parts of the Centers for Disease Control and Prevention, which currently houses NIOSH, also remain off the job, despite calls from states and lawmakers for their reinstatements. HHS previously said it was planning on moving what remained of NIOSH into a new agency called the Administration for a Healthy America. Among the CDC scientists still laid-off include the agency's laboratories for investigating STD and viral hepatitis, which upended work helping states investigate outbreaks. Staff in the CDC's National Center for Environmental Health, which had been responsible for a range of issues including lead poisoning and cruise ship outbreaks, also have not been reinstated. Other workers who have been promised by their supervisors that they would be reinstated elsewhere at HHS have also so far not received notices, like at the Food and Drug Administration's drug safety labs in Puerto Rico and Detroit. While their counterparts at food safety labs in Chicago and San Francisco were reinstated, multiple scientists in those labs said they had yet to receive formal written notices revoking their layoffs, weeks after they were told they would be reinstated.
Yahoo
13-05-2025
- Health
- Yahoo
FDA's latest MAHA move would wipe out kids' fluoride prescriptions as health risk evidence mounts
The Food and Drug Administration (FDA) announced Tuesday it is taking a step toward "ending outdated practices" related to children's health and will begin removing ingestible fluoride prescription drug products for kids from the market. Health and Human Services and the FDA are "taking bold action to protect America's children by initiating the removal of unapproved, ingestible fluoride prescription drug products from the market," Department of Health and Human Services spokesman Andrew Nixon told Fox News Digital Tuesday. "These fluoride prescription drug products, given to infants and toddlers, have never been approved by the FDA and pose real risks to developing children — including harm to the gut microbiome, potential thyroid dysfunction, weight gain, and even reduced IQ. This is not just a public health issue — it's a moral issue." "This marks another step toward delivering on our Make America Healthy Again promise — by ending outdated practices and putting Gold Standard Science at the center of children's health," he added. The FDA announced earlier Tuesday it had begun the initial steps of removing "concentrated ingestible fluoride prescription drug products for children from the market." Fluoride is frequently used to protect teeth from decay and cavities. Desantis Signs Bill Banning Fluoride Additives In Florida Public Water: 'Hydrate, Not Medicate' Read On The Fox News App Ingestible fluoride, such as tablets prescribed to kids at high-risk for cavities, was never approved by the FDA, according to its chief, Marty Makary, and have been "shown to alter the gut microbiome," as well as possible association "between fluoride and thyroid disorders, weight gain and possibly decreased IQ." Ingestible fluoride is swallowed, and differs from other fluoride products, such as toothpaste bolstered with fluoride. Utah Bans Fluoride From Public Drinking Water, Aligning With Maha Movement Makary said in a Tuesday press release that children can avoid heavy sugar intake to dodge cavities instead of "altering a child's microbiome." The gut microbiome is the ecosystem of microorganisms that live in a person's intestines. "The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child's microbiome," Makary said in the press release. "For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child's health." "I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety." Fluoride Exposure Linked To 'Detrimental Effects' On Health Of Pregnant Women, Infants Nixon told Fox News Digital that HHS and the FDA will launch a full safety review, including with public input, as health leaders work to finalize details of the plan by Oct. 31. "The American people deserve transparency and accountability," Nixon said. "The Department will issue new guidelines promoting safe, effective dental hygiene without compromising gut health." HHS Secretary Robert F. Kennedy Jr. added in the press release that "ending the use of ingestible fluoride is long overdue." Rfk Jr. Calls For Removal Of Fluoride From Drinking Water, Sparking Debate "I'm grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children," Kennedy said. "This decision brings us one step closer to delivering on President Trump's promise to Make America Healthy Again." Kennedy posted to X following President Donald Trump's election win in November 2024 that the Trump administration "will advise all U.S. water systems to remove fluoride from public water" upon Inauguration Day. Children Exposed To Higher Fluoride Levels Found To Have Lower Iqs, Study Reveals "Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease. President @realDonaldTrump and First Lady @Melaniatrump want to Make America Healthy Again," he continued. Trump told the media shortly after Kennedy's X post that such a plan to remove fluoride from water systems "sounds OK to me." First State To Ban Fluoride In Drinking Water Will Heed Maha Movement's Call To Action Utah became the first state in the nation to ban fluoride from public water systems in May, while Republican Florida Gov. Ron DeSantis signed a bill May 6 banning fluoride additives to the state's public water supply. That law will take effect July 1. "Jamming fluoride in the water supply … is essentially a forced medication," DeSantis said during a news conference May 6 in Tallahassee, Florida. "At the end of the day, we should all agree that people deserve informed consent." Amid states moving to ban fluoride from water systems specifically, local dentists and critics of the move claim it will hurt residents who rely on the fluoride to bolster dental article source: FDA's latest MAHA move would wipe out kids' fluoride prescriptions as health risk evidence mounts
