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RFK Jr. rescinds endorsements for some flu vaccines
RFK Jr. rescinds endorsements for some flu vaccines

Boston Globe

time24-07-2025

  • Health
  • Boston Globe

RFK Jr. rescinds endorsements for some flu vaccines

The decision will not affect most Americans seeking flu vaccines: Thimerosal is added to multidose vials of flu vaccines to prevent bacteria from growing, but it is not an ingredient of the single-dose vials administered to most people. During the 2024-25 respiratory virus season, only 3% of children and 2% of older adults received flu vaccines containing thimerosal, according to an analysis of electronic health records by Truveta, a company that analyzes such records. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up Still, multidose vials are needed in places where it is difficult to store many vaccines, such as nursing homes or mobile clinics serving remote rural areas. Advertisement Kennedy's sign-off does not withdraw vaccines containing thimerosal from the market. But his rescinding the federal recommendation means that such shots may not be available to Americans, because insurance companies are no longer required to cover them. 'We urge global health authorities to follow this prudent example for the protection of children worldwide,' Kennedy said in a statement. Vaccine manufacturers have confirmed that they have the capacity to replace multidose vials containing mercury, ensuring that vaccine supplies for children and adults will 'remain uninterrupted,' the Department for Health and Human Services said in a statement. Advertisement Federal health officials began removing thimerosal from childhood vaccines about 25 years ago, citing an abundance of caution despite a lack of data supporting safety concerns. Dozens of studies have shown thimerosal to be harmless. But the anti-vaccine community has long falsely maintained that the ingredient can cause neurological problems. At a meeting of the vaccine advisers last month, Lyn Redwood, a former leader of Children's Health Defense, the anti-vaccine group founded by Kennedy, claimed thimerosal was dangerous and toxic to children. Her presentation incorrectly said the only flu vaccine still containing thimerosal had 50 micrograms per dose, double the actual amount. The seven new advisers voted 5-1, with one abstention, to withdraw recommendations for flu vaccines containing thimerosal for children, pregnant women and other adults. The director of the Centers for Disease Control and Prevention typically accepts the recommendations of the committee. But the agency does not currently have a leader, so the decision fell to Kennedy. This article originally appeared in .

Trump Administration Live Updates: Trump Rallies for His Policy Bill as G.O.P. Works to Save It
Trump Administration Live Updates: Trump Rallies for His Policy Bill as G.O.P. Works to Save It

New York Times

time27-06-2025

  • Health
  • New York Times

Trump Administration Live Updates: Trump Rallies for His Policy Bill as G.O.P. Works to Save It

Lyn Redwood, who once ran the anti-vaccine group that Robert F. Kennedy Jr. founded, spoke during the meeting on Thursday. An advisory panel recently appointed by Health Secretary Robert F. Kennedy Jr. voted on Thursday to walk back longstanding recommendations for flu vaccines containing an ingredient that the anti-vaccine movement has falsely linked to autism. The vote signaled a powerful shift in the way federal officials approach vaccines, putting into action Mr. Kennedy's deep skepticism about their safety and delivering the first blows to a scientific process that for decades has provided effective vaccines to Americans. Mr. Kennedy fired all 17 experts on the panel about two weeks ago, and then appointed eight new members, at least half of whom have expressed skepticism about some vaccines. 'We came to this meeting with no predetermined ideas, and will make judgments as if we are treating for our own families,' the panelists said in a statement. To critics, the two-day meeting of the Advisory Committee on Immunization Practices offered the clearest signs yet that the Trump administration intends to unravel the system that has long guided clinical decisions about vaccination. 'As a physician and scientist who has devoted my entire career to vaccines and preventing and treating infections, this meeting has been devastating to watch,' said Dr. Lakshmi Panagiotakopoulos, an expert on vaccines who resigned from the Centers for Disease Control and Prevention earlier this month. Dozens of studies have shown the vaccine ingredient, called thimerosal, to be harmless. It has not been a component of most childhood shots since 2001. 'The risk from influenza is so much greater than the nonexistent risk as far as we know from thimerosal,' said the lone dissenter, Dr. Cody Meissner, a professor of pediatrics at Dartmouth Geisel School of Medicine who is widely considered to be the most qualified member of the new committee. 'I find it very hard to justify' the panel's decision, he added. In a separate vote, the new panel recommended seasonal flu vaccines to all Americans 6 months and older. The common single-dose flu shots do not contain thimerosal. The committee advises the C.D.C. on vaccine efficacy and safety, and it makes recommendations regarding who should receive a vaccine and when. Insurance companies and government programs like Medicaid are required to cover immunizations that the C.D.C. recommends, and states base their school mandates on the agency's guidance. In addition to certain flu vaccines, some panelists on Thursday questioned the safety of other products that have already been approved by the Food and Drug Administration and thoroughly vetted by independent experts. Others seemed unaware of basic information about the Vaccines for Children program, which provides free immunizations to roughly half of all American children. 'It's striking how little the voting members seem to know about the diseases and vaccines that they are discussing,' said Dr. Adam Ratner, a pediatric infectious diseases specialist and expert on vaccine policy. During the deliberations on a vaccine for respiratory syncytial virus, known as R.S.V., one of the panelists, Dr. Robert Malone, said that there had been 'very, very active discussion and consideration within the committee, just for the record, concerning this product.' 'It has been very actively debated internally,' he said. Outside experts interpreted his remarks to mean that panelists had been privately discussing the topic among themselves, something that they are not legally allowed to do. Image Dr. Robert Malone was among the panelists on Wednesday. Credit... Megan Varner/Reuters 'In other contexts, off-record conversations have been grounds for overturning a decision,' said Dorit Reiss, an expert on vaccine policy and law at the University of California College of the Law, San Francisco. 'Though it reflects lack of understanding of their limits, it's unlikely to lead to overturning,' she added. A spokesman for the Health and Human Services Department said that Dr. Malone had been referring to a one-on-one conversation between Dr. Malone and another panelist, which was 'permissible.' Presentations at the meetings are generally made by C.D.C. staff members. But among the speakers on Thursday was Lyn Redwood, a former leader of Children's Health Defense, the anti-vaccine group founded by Mr. Kennedy. Ms. Redwood, who has been hired as a special employee at the Health and Human Services Department, alleged in the meeting that thimerosal was toxic and dangerous to children. (She said that she was making the comments as 'a private citizen.') A scientific review of evidence demonstrating the safety of thimerosal was posted online by C.D.C. scientists on Tuesday but taken down shortly thereafter. 'Giving someone like Lyn Redwood a voice at the A.C.I.P. meeting to spread misinformation about a long-settled matter of vaccine safety is yet another troubling way in which R.F.K. Jr. is inappropriately interfering with the C.D.C. vaccine policy process,' said Dr. Fiona Havers, who resigned last week from her position as a senior C.D.C. adviser on vaccine policy. Image Dr. Fiona Havers, who resigned from her position as a senior C.D.C. adviser on vaccine policy. Credit... Melissa Golden for The New York Times On Wednesday, The New York Times reported that Ms. Redwood's presentation incorrectly said the only flu vaccine still containing thimerosal had 50 micrograms per dose, double the actual amount. That slide was removed from the version Ms. Redwood offered on Thursday, but the inaccurate information was repeated in a different slide. Her presentation had also initially included references to studies that did not exist; that slide was also removed. During the 2024-25 respiratory virus season, only 3 percent of children and 2 percent of older adults received flu vaccines containing thimerosal, according to an analysis of electronic health records by Truveta. Dr. Meissner sharply objected to Ms. Redwood's comments. 'I'm not quire sure how to respond to this presentation,' he said. 'This is an old issue that has been addressed in the past.' 'There is no scientific evidence that thimerosal has caused a problem,' he added. Liaisons to the A.C.I.P. from several organizations, including the American College of Obstetricians and Gynecologists, also challenged the idea that thimerosal is toxic. In another unusual move, Martin Kulldorff, the panel's chair, proposed that the members vote to stop allowing the use of a vaccine for measles, mumps, rubella and chickenpox for children under 4. That combination vaccine has been available since 2005. It slightly increases the risk of febrile seizures, which can occur with any childhood illness but do not cause lasting harm. The C.D.C. already recommends administering the M.M.R. shot and the chickenpox shot separately in the first dose. The panelists are expected to vote on the vaccine's use at a future meeting. The committee sounded a skeptical note with its very first vote on Thursday. Clesrovimab is a new monoclonal antibody approved by the F.D.A. this month to protect infants from R.S.V. infection. The committee's vote on recommending it was expected to be straightforward, as clesrovimab is not technically a vaccine. But a new panel member, Retsef Levi, a professor of operations science at the Massachusetts Institute of Technology, said that he would like to discuss some data he 'had found' from clinical trials that raised concerns about deaths in children receiving the product. Experts from the C.D.C. and the F.D.A., and the vaccine's manufacturer, all said the data had been reviewed very carefully before the antibody's approval and did not reveal any association between the deaths and the product. Image Vicky Pebsworth, a nurse affiliated with an anti-vaccine group, attended the meeting virtually on Wednesday. Credit... Megan Varner/Reuters Experts watching the proceedings were incensed. 'These trials have been discussed at length at prior meetings, and the questions were answered to the satisfaction of all of the members,' said Dr. Sean O'Leary, the chair of the infectious disease committee at the American Academy of Pediatrics, and a member of the R.S.V. work group convened by the C.D.C. Dr. Meissner, the panelist who dissented in the vote on flu vaccines, noted that the work group of 60 experts, including himself, had reviewed the safety data 'very, very carefully.' He defended both the monoclonal antibody and an R.S.V. vaccine for pregnant women as valuable new tools. R.S.V. is the leading cause of hospitalizations in infants. 'We have come so far in the last few years in making these products available, and really it's a result of the extraordinary investigations,' Dr. Meissner said. Safety, he added, 'is simply not an issue here.' Another monoclonal antibody, nirsevimab, sharply reduced R.S.V. hospitalizations among infants during the 2024-25 season, and so far it does not appear to pose serious safety concerns, according to data presented at the meeting on Wednesday. Dr. Levi and Vicky Pebsworth, a nurse affiliated with an anti-vaccine group, voted against recommending clesrovimab; the other five members voted yes. After some confusion, the panel also voted to include the antibody in the children's vaccine program. Some panelists also raised concerns about a flu vaccine that would be offered to everyone aged 9 and older. As of June 14, flu was associated with 250 deaths in children in the United States, according to data presented on Thursday. Dr. Malone called that a 'modest number,' but some experts noted that the number of deaths was the highest in a nonpandemic year in a long time, and almost certainly an undercount.

Anti-vaccine activist presents data to RFK Jr.'s reshaped CDC advisory panel
Anti-vaccine activist presents data to RFK Jr.'s reshaped CDC advisory panel

Yahoo

time26-06-2025

  • Health
  • Yahoo

Anti-vaccine activist presents data to RFK Jr.'s reshaped CDC advisory panel

A longtime anti-vaccine activist gave a presentation at the Centers for Disease Control and Prevention's vaccine advisory committee meeting Thursday on an issue that has long been considered settled science. It was perhaps the clearest sign of how meetings of the panel, called the Advisory Committee on Immunization Practices, have already changed drastically under Health and Human Services Secretary Robert F. Kennedy Jr., who recently fired all 17 members of the panel and replaced them with a group of his own appointees. The presenter, nurse practitioner Lyn Redwood, is the president emerita of Children's Health Defense, the anti-vaccine group founded by Kennedy. Her presentation focused on thimerosal, a mercury-based preservative that had previously been used in some vaccines. Since 2001, however, nearly all vaccines made in the United States contain no thimerosal or only trace amounts. The exception is the multi-dose flu shot vials, though most flu shots now come in single-dose packaging that doesn't contain the preservative. Anti-vaccine activists have long claimed that thimerosal is linked to autism, but the link has been widely debunked. Redwood referenced 'neurodevelopmental disorders' rather than autism in her presentation, but after the presentation asserted links between thimerosal and brain inflammation, which she called 'one of the hallmarks that we see in autism.' A background briefing document that was available on the CDC's website Tuesday said that a summary of studies found 'no association between prenatal exposure to thimerosal-containing vaccinations and autism spectrum disorder in children.' The document was taken down Wednesday without explanation. ACIP member Dr. Robert Malone said Thursday during the meeting that, based on his understanding, 'that article was not authorized by the Office of the Secretary and has been removed.' Dr. David Higgins, a pediatrician and preventive medicine specialist at the University of Colorado Anschutz Medical Campus, decried the document's removal. 'Decades of evidence were ignored or even hidden,' said Higgins, who wasn't a part of the meeting. 'That's not being transparent. That's not scientific integrity.' Following the presentation, the committee voted 5-1 to recommend that children, adults and pregnant women get single-dose thimerosal-free flu vaccines. One member, Vicky Pebsworth, abstained. Before ACIP recommendations are implemented, the CDC director must sign off on them. However, there is currently no director in place as the nominee for the position, Susan Monarez, awaits confirmation by the Senate. In the absence of a director, Kennedy has the authority to adopt the ACIP's recommendations. ACIP recommendations do not mean the multi-dose vials are banned; for that to happen the Food and Drug Administration would need to revoke approval. Thimerosal-free flu shots account for the majority of the doses given in the U.S. Just 4%-5% of flu vaccines used during the 2024-2025 season were multi-dose, thimerosal-containing vaccines, Tracey Beth Høeg, a special advisor to the FDA commissioner, said during the meeting. Dr. Cody Meissner, a pediatrician, was the lone dissenting vote. 'The risk from influenza is so much greater than the nonexistent, as far as we know, risk from thimerosal,' Meissner said of his vote. 'I would hate for a person not to receive the influenza vaccine because the only available preparation contains thimerosal. I find that very hard to justify.' Meissner had initially followed up Redwood's presentation by saying he wasn't sure how to respond to it. 'This is an old issue that has been addressed in the past,' he said. Multiple infectious disease experts said on a Thursday press call following the ACIP meeting that multi-dose vaccines can be useful for vaccinating large groups such as workers. The decision not to recommend thimerosal-containing vaccines could also dissuade other countries — where multi-dose vials are more common — from using them, thereby reducing vaccine access, they added. Dr. Sean O'Leary, the American Academy of Pediatrics' liaison to ACIP, called Redwood's presentation 'unprecedented.' 'That was a highly-biased presentation full of cherry-picked data and junk science,' O'Leary said. 'The vast majority of it wasn't actually relevant to thimerosal in vaccines.' O'Leary told reporters in a call on Thursday that the AAP chose not to participate in the meeting, which it usually does. 'This meeting showcased an ACIP that has drifted so far from its long-standing focus on science, evidence and public health. When that focus returns, we will, too,' he said. Higgins, the Colorado pediatrician who was not part of the meeting, said, 'it's outrageous that a decision as consequential as this would be decided based on a single presentation from someone who arguably is not an expert in the field.' Redwood's presentation also triggered a slew of responses from representatives of major medical organizations participating in the meeting, who questioned the veracity of the data presented and asked to see credible scientific evidence. 'Will there be an actual CDC presentation done by staff scientists, physicians and those who are subject matter experts with accurate, peer-reviewed scientific data,' Dr. Jason Goldman, American College of Physicians' liaison to ACIP, asked the committee, 'or will we have lay person presentations only?' Committee Chair Martin Kulldorff, a biostatistician who has criticized pandemic lockdowns and Covid vaccines, scolded those representatives for their pushback. 'I think it's inappropriate to dismiss a presentation just because the person does not have a Ph.D., or an MD,' he said. 'There are a lot of knowledgeable people who we would like to hear from, and we want to hear from a variety of viewpoints. And I think today's discussion is a very good example that we have received input from a variety of people on this topic.' In a separate vote, the committee reaffirmed the existing recommendation that people ages 6 months and older should get annual flu shots, with six votes in favor. Pebsworth again chose to abstain. Earlier Thursday, the committee voted on whether to recommend an RSV drug for infants younger than 8 months. Five members voted in favor and two voted against, providing the majority vote needed for the recommendation to pass. The drug up for a vote Thursday, clesrovimab, is a monoclonal antibody injection that can prevent lower respiratory disease in infants during or before their first RSV season, which typically starts in the fall and peaks in the winter. RSV leads to up to 300 deaths a year among those younger than 5 in the U.S. A dramatic spike in severe RSV overwhelmed children's hospitals in late 2022. Clesrovimab was approved by the Food and Drug Administration earlier this month. A similar drug, nirsevimab, has also been approved for infants and some young children since 2023. A vaccine for pregnant women that also protects newborns is approved as well. Meissner, who was part of the committee's work group on RSV, fielded questions from fellow members about the trial data and the disease itself. He explained how newborns' tiny airways put them at higher risk for severe illness. That risk, he said, falls in their second year of life, when the airways are larger. The work group determined that the drug was effective at preventing severe RSV in young infants and had a favorable safety profile. 'These are truly remarkable products. They are safe and they're effective,' Meissner said. 'The FDA has spent an enormous amount of time looking at safety and efficacy.' Despite this, two members of the group, Retsef Levi and Vicky Pebsworth, questioned the drug's safety and voted not to recommend it. This article was originally published on

Kennedy's advisers endorse flu vaccines — except for a few targeted by antivaccine activists
Kennedy's advisers endorse flu vaccines — except for a few targeted by antivaccine activists

Japan Today

time26-06-2025

  • Health
  • Japan Today

Kennedy's advisers endorse flu vaccines — except for a few targeted by antivaccine activists

Lyn Redwood, a nurse practitioner who once ran the anti-vaccine group that Robert F. Kennedy Jr. founded, attends a meeting of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention in Atlanta on Thursday, June 26, 2025. (AP Photo/Shelby Lum) By MIKE STOBBE and LAURAN NEERGAARD The Trump administration's new vaccine advisers on Thursday endorsed this fall's flu vaccinations for just about every American but threw in a twist: Only use certain shots free of an ingredient antivaccine groups have falsely tied to autism. What is normally a routine step in preparing for the upcoming flu season drew intense scrutiny after U.S. Health Secretary Robert F. Kennedy Jr. abruptly fired the influential 17-member Advisory Committee on Immunization Practices and handpicked replacements that include several vaccine skeptics. That seven-member panel bucked another norm Thursday: It deliberated the safety of a preservative used in less than 5% of U.S. flu vaccinations based on a presentation from an antivaccine group's former leader — without allowing the usual public airing of scientific data from the Centers for Disease Control and Prevention. The preservative, thimerosal, has long been used in certain vaccines that come in multi-dose vials, to prevent contamination as each dose is withdrawn. But it has been controversial because it contains a small amount of a particular form of mercury. Study after study has found no evidence that it causes autism or other harm. Yet since 2001, all vaccines routinely used for U.S. children age 6 years or younger have come in thimerosal-free formulas — including single-dose flu shots that account for the vast majority of influenza vaccinations. The advisory panel first voted, with one abstention, to back the usual U.S. recommendation that nearly everyone age 6 months and older get an annual flu vaccination. Then the advisers decided people should only be given thimerosal-free single-dose formulations, voting 5-1 with one abstention. That would include single-dose shots that already are the most common type of flu vaccination as well as the nasal spray FluMist. It would rule out the subset of flu vaccine that is dispensed in multi-dose vials. 'There is still no demonstrable evidence of harm,' one panelist, Dr. Joseph Hibbeln, a psychiatrist formerly with the National Institutes of Health, said in acknowledging the committee wasn't following its usual practice of acting on evidence. But he added that 'whether the actual molecule is a risk or not, we have to respect the fear of mercury' that might dissuade some people from getting vaccinated. Normally the CDC's director would decide whether to accept ACIP's recommendation, but the Senate has not yet confirmed nominee Susan Monarez. Administration officials said Kennedy would make that decision. While Thursday's debate involved only a small fraction of flu vaccines, some public health experts contend the discussion unnecessarily raised doubt about vaccine safety. Already, fewer than half of Americans get their yearly flu vaccinations, and mistrust in vaccines overall is growing. 'What should have been a rigorous, evidence-based discussion on the national vaccine schedule instead appeared to be a predetermined exercise orchestrated to undermine the well-established safety and efficacy of vaccines and fundamental basics of science,' said Dr. Jason Goldman of the American College of Physicians. Public health experts decried the panel's lack of transparency in blocking the presentation of CDC's analysis of thimerosal that concluded there was no link between the preservative and neurodevelopmental disorders, including autism. The data had been posted on the ACIP's website Tuesday, but was later removed — because, according to ACIP member Dr. Robert Malone, the report hadn't been authorized by Kennedy's office. Committee members said they had read it. The ACIP, 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. Kennedy has long held there was a tie between thimerosal and autism, and also accused the government of hiding the danger. Thimerosal was placed on the meeting agenda shortly after Kennedy's new vaccine advisers were named last week. © Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

Kennedy's vaccine committee to vote on flu vaccines and controversial preservative
Kennedy's vaccine committee to vote on flu vaccines and controversial preservative

Boston Globe

time26-06-2025

  • Health
  • Boston Globe

Kennedy's vaccine committee to vote on flu vaccines and controversial preservative

Advertisement On Thursday, the vaccine panel voted 5-2 that another newly approved antibody shot, Merck's clesrovimab, should be used similarly. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up The ACIP, created more than 60 years ago, helps the Centers for Disease Control and Prevention 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. Kennedy was a leading voice in the antivaccine movement before becoming the nation's top health official. He fired the previous 17-member panel this month and replaced it with a seven-member group that includes several vaccine skeptics. At its June meetings, the committee usually refreshes guidance for Americans 6 months and older to get a flu shot, and helps propel the annual fall vaccination campaign. Advertisement Presentations prepared for Thursday's meeting suggest that the panel may do much the same this year. But there's also a flu-related vote that promises controversy. It concerns thimerosal, a form of mercury that's been added to vaccines since the early 20th century to preventing bacterial contamination in multi-dose vials. Kennedy has long held there was a tie between thimerosal and autism, and also accused the government of hiding the danger. Study after study has found no evidence that thimerosal causes autism. But since 2001, vaccines manufactured for the U.S. market and routinely recommended for children 6 years or younger have contained no thimerosal or only trace amounts, with limited exceptions. Thimerosal was placed on the meeting agenda shortly after Kennedy's new vaccine advisory was named last week. Before the vote, the committee will hear from Lyn Redwood, the former president of what is now known as Children's Health Defense — an antivaccine group founded by Kennedy. Some public health experts contend the thimerosal discussion will unnecessarily raise doubt in vaccines while possibly also making them more expensive and harder to get this fall. At the panel's meeting Wednesday, Chrissie Juliano, executive director of the Big Cities Health Coalition, lamented the ouster of the former ACIP panel and the agenda of the new one. Her organization, which represents large city health departments, '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,' she said. 'The stakes are simply too high to let that happen.' ___ Neergaard reported from Washington.

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