Kennedy's new vaccine advisers meet for first time
Health Secretary Robert F. Kennedy Jr. (Special to the American Press)
U.S. Health Secretary Robert F. Kennedy Jr.'s new vaccine advisers began their first meeting Wednesday under intense scrutiny from medical experts worried about Americans' access to lifesaving shots.
First on the agenda is an awkward scenario: Kennedy already announced COVID-19 vaccines will no longer be recommended for healthy children or pregnant women, and his new advisers aren't scheduled to vote on whether they agree. Yet government scientists prepared meeting materials calling vaccination 'the best protection' during pregnancy — and said most children hospitalized for COVID-19 over the past year were unvaccinated.
COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most at risk for hospitalization are seniors and children under 2 — especially infants under 6 months who could have some protection if their mom got vaccinated during pregnancy, according to the CDC's presentation.
It's one signal that this week's two-day meeting of the Advisory Committee on Immunization Practices isn't business as usual.
Another sign: Shortly before the meeting, a Virginia-based obstetrician and gynecologist stepped down from the committee, bringing the panel's number to just seven. The Trump administration said Dr. Michael Ross withdrew during a customary review of members' financial holdings.
The meeting opened as the American Academy of Pediatrics announced that it will continue publishing its own vaccine schedule for children but now will do so independently of the ACIP, calling it 'no longer a credible process.'
The panel, created more than 60 years ago, helps the CDC determine who should be vaccinated against a long list of diseases, and when. Those recommendations have a big impact on whether insurance covers vaccinations and where they're available, such as at pharmacies.
Earlier this month, Kennedy abruptly dismissed the existing 17-member expert panel and handpicked eight replacements, including several anti-vaccine voices. And a number of the CDC's top vaccine scientists — including some who lead the reporting of data and the vetting of presentations at ACIP meetings — have resigned or been moved out of previous positions.
The highly unusual moves prompted a last-minute plea from a prominent Republican senator to delay this week's meeting. Sen. Bill Cassidy of Louisiana, a physician who chairs the chamber's health committee, said Monday that many of Kennedy's chosen panelists lack the required expertise and 'may even have a preconceived bias' against new vaccine technologies.
In a House hearing Tuesday, Kennedy defended his purge, saying the old panel had been 'a template for medical malpractice.'
Rep. Kim Schrier, a pediatrician and Democrat from Washington state, told Kennedy: 'I will lay all responsibility for every death from a vaccine-preventable illness at your feet.' Committee will vote on RSV protections
The two-day meeting's agenda on was abruptly changed last week.
Discussion of COVID-19 shots will open the session on Wednesday. Later in the day, the committee will take up RSV, with votes expected. On Thursday, the committee will vote on fall flu vaccinations and on the use of a preservative in certain flu shots.
RSV, or respiratory syncytial virus, is a common cause of cold-like symptoms that can be dangerous for infants.
In 2023, U.S. health officials began recommending two new measures to protect infants — a lab-made antibody for newborns and a vaccine for pregnant women — that experts say likely drove an improvement in infant mortality.
The committee will discuss another company's newly approved antibody shot, but the exact language for the vote was not released prior to the meeting.
'I think there may be a theme of soft-pedaling or withdrawing recommendations for healthy pregnant women and healthy children,' even though they are at risk from vaccine-preventable diseases, said Lawrence Gostin, a public health law expert at Georgetown University who co-authored a recent medical journal commentary criticizing the COVID-19 vaccination decision. Flu shot recommendations to be debated
At its June meetings, the committee usually refreshes guidance for Americans 6 month and older to get a flu shot, and helps greenlight the annual fall vaccination campaign.
But given the recent changes to the committee and federal public health leadership, it's unclear how routine topics will be treated, said Jason Schwartz, a Yale University health policy researcher who has studied the committee.
Thursday also promises controversy. The advisory panel is set to consider a preservative in a subset of flu shots that Kennedy and some antivaccine groups have falsely contended is tied to autism. In preparation, the CDC posted a new report confirming that research shows no link between the preservative, thimerosal, and autism or any other neurodevelopmental disorders.
Gostin said the agenda appears to be 'a combination of what we would normally expect ACIP to cover along with a mixture of potential conspiracy theories,' he said. 'We clearly are in a new normal that's highly skeptical of vaccine science.'
The committee's recommendations traditionally go to the Centers for Disease Control and Prevention director. Historically, nearly all are accepted and then used by insurance companies in deciding what vaccines to cover.
But the CDC currently has no director, so the committee's recommendations have been going to Kennedy, and he has yet to act on a couple recommendations ACIP made in April.
The CDC director nominee, Susan Monarez, is slated to go before a Senate committee on Wednesday.
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CNN
37 minutes ago
- CNN
What to know about thimerosal, a target of RFK Jr.'s new CDC vaccine advisers
Vaccines Disability issues Federal agencies Children's healthFacebookTweetLink Follow In the 1930s, vaccine makers began using a preservative called thimerosal to stave off microbial growth in their products. For the next six decades, it didn't receive much notice; ill effects appeared limited to minor local injection-site reactions, according to the US Food and Drug Administration. That changed in 1999, when US health officials asked pharmaceutical companies to remove thimerosal from vaccines. There was no evidence that it caused harm in the quantities used, but thimerosal contains a form of mercury, and questions had emerged about whether it could cause neurotoxicity when given in childhood vaccinations. Vaccine makers have removed it from all but a few shots, such as multidose vials of flu vaccine. In the meantime, subsequent studies have confirmed no link between thimerosal in vaccines and neurodevelopmental issues, including autism, and autism rates have continued to rise. So public health experts were puzzled when the preservative appeared on the agenda for this week's meeting of outside vaccine advisers to the US Centers for Disease Control and Prevention. 'I actually don't know any pediatric practices that even use that multidose influenza vaccine,' said Dr. Sean O'Leary, a pediatrician at Children's Hospital Colorado and former liaison to the CDC's Advisory Committee on Immunization Practices, or ACIP, for the American Academy of Pediatrics. The group is meeting on Wednesday and Thursday for the first time since US Health and Human Services Secretary Robert F. Kennedy Jr. dismissed the committee's previous 17 members, claiming they had conflicts of interest, and days later installed eight new advisers. Public health experts and lawmakers have called into question the credentials and backgrounds of some of the new panelists, and just before the meeting began, one member withdrew during the financial holdings review, an HHS spokesman said, bringing the panel down to seven. A presentation 'regarding thimerosal in vaccines' is scheduled for Thursday morning, followed by 'proposed recommendations' specifically about thimerosal in flu vaccines, according to an agenda posted Monday. The meeting is scheduled to conclude with a vote on the latter, a move that could lead to official CDC policy if adopted by agency leadership – or, without a confirmed director in place, by Kennedy. The last-minute addition of thimerosal to the agenda was a red flag for vaccine experts, who consider the science settled and fear that Kennedy – who led an anti-vaccine group called Children's Health Defense – is seeking to sow doubt about vaccine safety. Another former Children's Health Defense leader, Lyn Redwood, is slated to make a presentation on the topic at the meeting. Here's how thimerosal became such a hot-button issue. In 1997, Rep. Frank Pallone, a New Jersey Democrat concerned about mercury pollution in his community's lakes and rivers, attached an amendment to a US Food and Drug Administration reauthorization bill that would require the agency to catalogue intentionally introduced mercury compounds in drugs and food. That led to a possibly startling discovery: 'As people looked in vaccines, there was the potential that, by six months of age, infants could have received more thimerosal than was listed in several sources of what was considered safe levels of mercury,' said Dr. Walter Orenstein, who was director of the National Immunization Program at the CDC at the time. But those limits were set for methylmercury, the kind found in some fish, which is known to be toxic. Thimerosal contains ethylmercury, a different compound that's 'intrinsically less stable, and more readily metabolized, than methylmercury,' said Dr. Matthew Rand, an associate professor in the Department of Environmental Medicine at the University of Rochester who studies mercury toxicity. That means it's cleared from the body more quickly than methylmercury, according to the CDC, 'and is therefore less likely to cause any harm.' The FDA notes that there were no existing guidelines for ethylmercury. Still, the finding led to a number of emergency meetings among federal health officials and outside groups to determine what should be done, Orenstein recalled. 'While there was no evidence of harm from thimerosal, the general feeling was, 'let's get rid of it, because we don't need it,' ' he said. Moving to single-dose containers alleviated the need for a preservative, although it came at a higher expense for manufacturers. In 1999, the FDA sent a letter to manufacturers of US vaccines requesting their plans to remove thimerosal, and by 2001, the compound had been removed from or reduced in all vaccines routinely recommended for children under 6 in the US, according to the CDC. The message from public health agencies, Orenstein said, was 'we're going to make safe vaccines even safer.' But the die was cast. Vaccines had already been tied to autism in 1998 by British doctor Andrew Wakefield, who published a since-retracted paper that claimed the measles-mumps-rubella vaccine was linked to autism, although not because of thimerosal – the MMR vaccine never contained the preservative. Still, parents of children with autism were seeking answers. One of those parents was Redwood, who said that in 1999, she tallied up her son's mercury exposure and found 'at two months of age, he had received 125 times his allowable exposure to mercury based on EPA's guidelines in his weight.' 'That was a real answer for me,' Redwood said in a video posted by Children's Health Defense this month, 'because my son at this time was almost 5 years old, and he had regressed developmentally after his first year of life and was diagnosed with autism.' Redwood, a nurse practioner, decided to become an advocate, speaking at events and publishing papers about thimerosal and autism. The uproar over a potential link between thimerosal and autism came as a surprise to Orenstein and colleagues. 'Mercury itself had never been implicated as a major cause of autism,' Orenstein said. 'But this was a major, major concern.' It led to a number of studies of the issue, including a 2004 assessment by the Institute of Medicine (now known as the National Academy of Medicine) that concluded 'the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.' It made the same conclusion for MMR vaccines and autism. A 2010 study by the CDC also found no link. And 'even after thimerosal was removed from almost all childhood vaccines, autism rates continued to increase,' the agency noted, 'which is the opposite of what would be expected if thimerosal caused autism.' Still, those who continued to push the disproven autism connection included Kennedy, who published a book in 2014 called 'Thimerosal: Let the Science Speak.' Its subtitle calls for the 'immediate removal of mercury – a known neurotoxin – from vaccines.' It rejects the findings of the 2004 Institute of Medicine report and warns that millions of children in the US and around the world 'appear to be at risk of injury from the thimerosal in vaccines.' Thimerosal is still present in 'a small percentage of flu vaccines, confined to multidose vials,' according to a post from the Vaccine Integrity Project, a group focused on countering vaccine misinformation that was started at the University of Minnesota's Center for Infectious Disease Research and Policy, or CIDRAP. The group suspects that thimerosal is included on ACIP's agenda this week – with a presentation by Redwood and a vote by the committee – 'to put greater focus on and generate more public discussion about vaccine risk.' HHS didn't return a request for comment about Redwood's involvement in this week's meeting, and Redwood declined to comment. Her presentation slides, however, were posted ahead of the meeting and continued to claim thimerosal presents safety risks. One slide initially included in the presentation cited a study in animals that appeared not to exist; its apparent lead author told CNN he'd published a study with a similar title, but in a different journal, in different animals, and with dramatically different findings — ones that didn't appear to show a link between autism and thimerosal. The slide presentation was subsequently updated to remove that slide. CDC staff also posted its own review of the data, citing nearly two dozen studies showing 'the evidence does not support an association between thimerosal-containing vaccines and autism spectrum disorder or other neurodevelopmental disorders.' During her Senate Health, Education, Labor and Pensions committee confirmation hearing on Wednesday, Dr. Susan Monarez, President Donald Trump's pick to lead the CDC, said, 'I have not seen a causal link between vaccines and autism.' The decision to remove thimerosal from most vaccines, despite no evidence of harm, had other consequences. At the same time the FDA made its request to vaccine makers, US health authorities advised that babies born to mothers known to be negative for hepatitis B not receive a shot for that virus at birth, but at two months to 6 months of age, as thimerosal was phased out. But about 10% of hospitals 'suspended use of the hepatitis B vaccine for all newborns, regardless of their level of risk,' wrote Dr. Paul Offit, a vaccine scientist at the Children's Hospital of Philadelphia and a member of the FDA's outside advisory committee on vaccines, in a 2007 perspective piece in the New England Journal of Medicine. 'One three-month-old child born to a Michigan mother infected with hepatitis B virus died of overwhelming infection.' Orenstein looks back on the decision to remove thimerosal as a hard one. 'The fear would be keeping it in there, doing a study over two or three years and then it showed harm, and lo and behold, for three years, we used this vaccine and this component was harmful,' he said. 'Since we didn't know what the results would be of any of the studies at the time, we thought it better to just get it out of there. 'The autism issue,' he added, 'didn't play any role in the initial decision.' CNN's Brenda Goodman contributed to this report.
USA Today
43 minutes ago
- USA Today
Inside the unusual, RFK-appointed panel that's deciding on childhood vaccines
The world just got its first look at the inner workings of the new vaccine panel appointed by Health and Human Services Secretary Robert F. Kennedy and their immediate focus: childhood vaccines. The eight new members of the Advisory Committee on Immunization Practices met for the first time on June 25, where ACIP Chair Martin Kulldorf announced at the top of the meeting how the panel plans to reexamine the childhood immunization schedule. "The number of vaccines that our children and adolescents receive today exceeds what children in most other developed nations receive and what most of us in this room received when we were children," he said. "In addition to studying and evaluating individual vaccines, it's important to evaluate the cumulative effect of the recommended vaccine schedule." Kulldorff added the committee will also establish workgroups to investigate vaccines that protect against measles, mumps and rubella and hepatitis B. Kennedy fired all 17 original members of the committee on June 9 and appointed its new members, which included some vaccine skeptics, a few days later. Their recommendations will have wide-ranging implications, guiding vaccine requirements for schools and impacting a government program offering free vaccinations for about half of America's kids. Many experts are concerned the panel's actions will sow doubt in vaccines that have been deemed safe and effective. More: Trump US CDC nominee backs vaccines as life-saving 'To raise doubt about our traditional pediatric vaccines that have saved millions of lives, particularly during one of the worst measles outbreaks we have had in years, is irresponsible and will cost lives,' said Dr. Gretchen LaSalle, a family physician in Spokane, Washington, who represents the American Academy of Family Physicians for an ACIP workgroup. The Centers for Disease Control and Prevention panel also reviewed data about COVID-19 vaccines, immediately questioning their safety and effectiveness. They also raised questions about the study design, methodologies and surveillance monitoring systems behind the data, which Dr. Pamela Rockwell, clinical professor of family medicine at the University of Michigan Medical School, addressed as standard of medical research. "Our efforts, through a very robust system of checks and balances, are to create vaccines and vaccination programs that result in the most benefit with the least harm," said LaSalle, from AAFP. The committee didn't vote on COVID-19 vaccine recommendations for the fall and isn't expected to reconvene until 'September/October,' according to the CDC website. 'Stakes are simply too high': Criticisms and controversies Public comment during the meeting was a mix of voices raising criticisms and concerns about potential harm, from different perspectives. Nurses, pediatricians, public health experts and mothers flooded the public comment portion of the meeting to criticize Kennedy's decision to fire the 17 original ACIP members and advocate the protective benefits of vaccines. 'The Big Cities Health Coalition is deeply concerned that many routine vaccines may soon become inaccessible or unaffordable for millions of Americans if ACIP makes changes based on ideology rather than science,' Chrissie Juliano, executive director of the Big Cities Health Coalition, said during the public comment section. 'The stakes are simply too high to let that happen.' Others criticized vaccine mandates and medical exemption restrictions. 'With many new members in place, the ACIP must now act to prevent continued harm,' said Kim Mack Rosenberg, general counsel for Children's Health Defense, the anti-vaccine group founded by Kennedy. The planned vote on a new shot for respiratory syncytial virus, or RSV, was postponed due to time constraints. The ACIP meeting was held despite a national outcry from health experts, officials and organizations calling for a delay. Sen. Bill Cassidy, a Louisiana Republican and physician, urged officials to wait until the panel is 'fully staffed with more robust and balanced representation – as required by law – including those with more direct relevant experience.' 'Although the appointees to ACIP have scientific credentials, many do not have significant experience studying microbiology, epidemiology or immunology,' Cassidy, the chairman of the Senate Committee on Health, Education, Labor, and Pensions, said in a social media post. 'In particular, some lack experience studying new technologies such as mRNA vaccines, and may even have a preconceived bias against them.' Contributing: Ken Alltucker, USA TODAY. Adrianna Rodriguez can be reached at adrodriguez@
Newsweek
an hour ago
- Newsweek
Ozempic Linked to Significant Reduction in Dementia—Study
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Semaglutide, the active ingredient in diabetes medications Ozempic and Wegovy, was associated with a significantly reduced risk of developing Alzheimer's disease-related dementia among patients with type 2 diabetes, a recent study reported. A new study published in the Journal of Alzheimer's Disease analyzed the medical records of over 1.7 million U.S. adults and found that semaglutide users experienced a notably lower risk of dementia compared to patients treated with insulin, metformin, or older GLP-1 agonists. These findings, publicly released on Tuesday, come as researchers and clinicians continue to search for effective means to mitigate the growing dementia epidemic in the U.S. Ozempic is medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar. Ozempic is medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar. Photo by Steve Christo - Corbis/Corbis via Getty Images Why It Matters With over 6 million Americans diagnosed with dementia and more than 100,000 related deaths each year, the potential for semaglutide to meaningfully lower risk could have sweeping public health implications. Dementia does not have a cure, and nearly half of all cases are thought to be preventable by addressing risk factors like obesity, type 2 diabetes, and cardiovascular disease, the New York Post reported. Evidence supporting semaglutide's neuroprotective effects may inform future prevention strategies among high-risk populations in the U.S. What To Know Landmark Study Shows Sharp Risk Reduction Researchers at Case Western Reserve School of Medicine, National Institutes of Health and the MetroHealth System in Cleveland examined the health records of 1,710,995 U.S. patients with type 2 diabetes who had no prior diagnosis of Alzheimer's disease-related dementia (ADRD). The study used a statistical method simulating a randomized clinical trial, comparing dementia diagnoses among those prescribed semaglutide, insulin, metformin, and older GLP-1 receptor agonists. Patients treated with semaglutide had a 46 percent lower risk of developing ADRD than those receiving insulin, a 33 percent lower risk than those on metformin, and a 20 percent lower risk than those on earlier GLP-1 agonists. The effect was particularly pronounced for vascular dementia, one of the most common subtypes. No protective association was found for frontotemporal dementia or Lewy body dementia. Wide Demographic Impact Observed The protective association was consistent among subgroups, including younger and older patients, men and women, and those with and without obesity. Researchers found the risk reduction was especially evident among older adults and women. What is Semaglutide? Semaglutide is a glucagon-like peptide-1 receptor agonist that helps regulate blood sugar, lowers body weight, and offers cardiovascular benefits for patients with diabetes. The drug can help improve insulin sensitivity, protect blood vessels, and reduce inflammation in the brain. Important Study Limitations Authors acknowledged limitations, including reliance on administrative diagnosis codes, which are subject to underdiagnosis and misclassification, data on medication adherence, cognitive test scores, and genetic risk factors were unavailable. Variations in clinical practice and health care use variations could also affect findings. Researchers emphasized the need for preclinical and clinical studies to establish causal effects. Additional International Data A separate study by Oxford University, published in Lancet's eClinicalMedicine journal, analyzed more than 100 million U.S. medical records and found that Ozempic users experienced lower rates of cognitive decline and nicotine use compared to those on other diabetes medications. This study also did not find a higher risk of anxiety, depression, or other neurological and psychiatric conditions with Ozempic. The researchers emphasized that the results were limited to diabetic patients and require more rigorous randomized controlled trials. What People Are Saying The researchers of the study, in a news article published by the American Journal of Managed Care: "In a real-world population with T2D [type 2 diabetes] who had no prior diagnosis of AD/ADRD [Alzheimer disease/Alzheimer disease-related dementia], our study shows that semaglutide was associated with a significantly lower risk of overall ADRD incidence compared with other antidiabetic medications, including insulin, metformin, and other GLP-1RAs. Significant reductions were observed in older and younger patients, women and men, and patients with and without obesity." Howard Fillit, chief science officer of the Alzheimer's Drug Discovery Foundation, in comments to Reuters: "The answer to all those limitations is to do a randomized clinical trial, which is exactly what Novo is doing." What Happens Next Novo Nordisk, the maker of Ozempic, began testing semaglutide in patients with early Alzheimer's disease in 2021. The results are expected sometime this year. 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