Latest news with #Kulldorff
Mint
26-06-2025
- Health
- Mint
Robert F. Kennedy Jr-revamped vaccine panel to re-examine childhood immunization schedule, raising alarm
A federal vaccine advisory committee is preparing to re-evaluate the childhood vaccination schedule and reexamine long-standing immunizations, a move that has triggered alarm over concerns about potential changes to established vaccine recommendations. On Wednesday (June 25), the newly appointed Advisory Committee on Immunization Practices (ACIP) met for the first time under its new chair, Martin Kulldorff. Kulldorff announced the creation of two new work groups: one to scrutinize the cumulative effects of all recommended vaccines in children and adolescents, and another to review vaccines that have not been evaluated in more than seven years. '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,' Kulldorff said during the meeting. He added: 'In addition to studying and evaluating individual vaccines, it is important to evaluate the cumulative effect of the recommended vaccine schedule. This includes interaction effects between different vaccines, the total number of vaccines, cumulative amount of vaccine ingredients, and relative timing.' Kulldorff explained that among the topics the committee could consider is whether hepatitis B shots should continue to be administered to newborns before hospital discharge. The group may also weigh the possibility of recommending separate measles, mumps, and rubella (MMR) and varicella vaccines instead of the combined MMRV shot, and look at adjusting the timing of MMR doses to address certain religious objections. 'This was supposed to be a regular practice of the ACIP, but it has not been done in a thorough and systematic way,' Kulldorff said. 'We are learning more about vaccines over time, and to stay true to evidence-based medicine, we have a duty and a responsibility to keep up to date with scientific research.' Earlier this month, Health Secretary Robert F. Kennedy Jr. removed all 17 members of the previous ACIP and appointed eight new members, many of whom have voiced skepticism about childhood vaccines. 'When I was a kid I got three vaccines,' Kennedy said. 'Today they get 69 to 92 jabs of vaccines between conception and when they are 18 years old.' Kennedy has frequently claimed that today's vaccination schedule is excessive and not sufficiently scrutinised. The American Academy of Pediatrics (AAP) swiftly condemned the developments. In a video statement, the AAP said: 'Immunization policy through ACIP is no longer a credible process.' The group pledged to continue publishing its own independent vaccine recommendations for children, regardless of ACIP deliberations.
Yahoo
26-06-2025
- Health
- Yahoo
First meeting of new CDC vaccine panel reveals policy chaos sown by RFK Jr
The first meeting of a critical federal vaccine panel was a high-profile display of how the US health secretary and vaccine skeptic Robert F Kennedy Jr has injected chaos into vaccine policy infrastructure. Wednesday's meeting was held amid controversy, not only regarding the new members unilaterally appointed by Kennedy, but also the questions they would consider, their conflicts of interest and views on vaccines, and the scheduled speakers. The new chair of the committee, former Harvard University professor of medicine Dr Martin Kulldorff, who was fired for refusing to be vaccinated against Covid-19, began the meeting by criticizing both his former employer and the media. 'Some media outlets have been very harsh on the new members of this committee,' said Kulldorff, who he said were put into 'either a pro- or anti-vaccine box'. 'Such labels undermine critical scientific inquiry and it further feeds the flames of vaccines hesitancy. As Secretary Kennedy has eloquently stated, opposing mercury in fish doesn't make you anti-fish, and opposing mercury in vaccines doesn't make you anti-vaccines,' Kulldorff continued, referring to one of the issues the panel would consider. Kulldorff also quickly announced the formation of two new working groups, in addition to the 11 that already serve the panel. One would study the interaction of vaccines and the cumulative childhood vaccine schedule – issues that have for years been talking points of anti-vaccine advocates including Kennedy – and another to reevaluate vaccines that have not been looked at in more than seven years. The latter would provide the committee's new members an opportunity to change recommendations for long-approved vaccines. The panel, the advisory committee on immunization practices (ACIP) to the Centers for Disease Control and Prevention (CDC), develops recommendations for how to administer vaccines to the American public. The ACIP meeting is high-stakes and will be widely watched within the scientific community, as former members argue that the nation's vaccine approval, research and distribution systems are being dismantled. The panel's decisions are highly influential in deciding which vaccines the CDC ultimately recommends for children and adults. In turn, those recommendations form the basis of how health insurers decide which vaccines to cover, and thus have a direct impact on the price and availability of vaccines to the American public. Experts consider the current situation so dire that outside groups are attempting to develop a system to provide vaccines to Americans in spite of Kennedy's attempts to disrupt the system. 'What we're seeing today, and if this were to continue, the medical public health professionals and the entire country are no longer going to trust ACIP,' said Dr Sean O'Leary of the American Academy of Pediatrics Council on School Health. 'That's very clear.' Related: US experts fear all vaccines at risk as Trump officials target mRNA jabs The panel met in spite of lack of clarity about a seemingly fundamental issue: conflicts of interest. Kennedy fired the 17 previous members of the panel after arguing they had 'been plagued with persistent conflicts of interest'. Before the presentations of the meeting started in earnest, the new members were asked to introduce themselves and verbally describe any conflicts of interest. It's unclear whether the new members have had conflict of interest disclosures published in writing ahead of the meeting. The new members did not appear on the Trump administration-developed conflict of interest tracker specifically for ACIP members as of Wednesday morning. A spokesperson for the Department of Health and Human Services (HHS) told the Guardian that the new members had undergone ethics review but did not respond to inquiries about when and where these disclosures would be published. The spokesperson also said one of the eight Kennedy-appointed members had dropped out on Tuesday evening after a government financial review. A spokesperson told the Guardian last week: 'Before they start their work on ACIP, the new members' ethics agreements will be made public.' Some members did not address any conflicts of interest, seeming to focus only on their introduction. Others, like Kulldorff, did not disclose past involvement with litigation against vaccine makers. Similarly, Dr Robert Malone did not appear to disclose his work in the litigation against the Merck vaccine. Instead, Malone said: 'Any potential conflicts of interest have been analyzed and vetted and declared lacking both internally by HHS and specifically by CDC.' Vicky Pebsworth, a nurse who holds a doctorate degree and has worked for decades as the volunteer research director for one of the oldest high-profile anti-vaccine groups in the country, said she was 'disclosing I hold stock to a healthcare sector fund including vaccine manufacturers; however, the amount of that stock holding is under the office of government ethics regulatory de minimus amount. I understand I therefore can fully participate in the ACIP meeting.' The agenda for the panel was also remade before the committee met. Previously, experts on the panel were scheduled to consider a recommendation for Covid-19 boosters. That vote was removed from the agenda – leaving experts to hear planned presentations on Covid-19, but not to vote – because the CDC was unable to hold a final working group call. It is unclear why the call was not held. CDC scientists explained how the Covid-19 'does remain a substantial burden among youngest and oldest age groups'. After the presentations, members of the ACIP asked whether the low uptake of the vaccine – that some had actively sown doubt about – should be considered a reason not to recommend it. 'The fact [that uptake is] so low is a reflection of the lack of trust many parents have with the Covid vaccination recommendation that the ACIP has been giving,' said Kulldorff. In another exchange, Pebsworth suggested that the CDC should be looking at 'animal studies' and 'reproductive toxicity' in relation to Covid-19 vaccines, arguing that only '10% of adverse events are reported'. Dr Sarah Meyer, a researcher with the CDC's immunization services division who presented on the topic, said the numbers referenced by Pebsworth were misleading because they included even the most minor 'adverse events', such as sore arms. 'For serious reports, we are confident we get a majority of those reported' to surveillance systems such as the Vaccines Adverse Event Reporting System. Instead, members were scheduled to only vote on whether to recommend a second monoclonal antibody, called Clesrovimab, for respiratory syncytial virus (RSV) for all infants younger than eight months old born during respiratory virus season. The vote was postponed because the meeting ran late. The committee is scheduled to meet again on Thursday. Other advisers joining the meeting reflect the way that Kennedy has remade the federal health department. Representing the Food and Drug Administration was Tracy Beth Høeg, a sports medicine physician and epidemiologist who has called for more scrutiny of vaccines. One of the experts scheduled to present to the panel on Thursday is nurse Lyn Redwood, the ex-president of Kennedy's anti-vaccine group Children's Health Defense, according to Politico. Key Republican Dr Bill Cassidy, whose vote helped assure Kennedy's confirmation to HHS, called for the meeting of the panel to be delayed, citing the new members' 'lack of experience' with vaccines and, in some cases, 'preconceived bias against them', according to STAT News. Further, the panel's new agenda cited a study that the cited author said he did not conduct or publish, according to Reuters, continuing a pattern of Kennedy's health department producing references to garbled or nonexistent studies even as Kennedy repeatedly touts 'gold-standard' science.
25-06-2025
- Health
CDC vaccine advisory panel to study child immunization schedule, delays RSV shot vote
The Centers for Disease Control and Prevention's vaccine advisory committee wrapped up the first day of its meeting since Health and Human Services Secretary Robert F. Kennedy Jr. dismissed the entire panel and appointed his own hand-selected members. The Advisory Committee for Immunization Practices (ACIP) met on Wednesday to discuss possible recommendations for respiratory syncytial virus (RSV) vaccines and antibody shots, as well as COVID-19 vaccine recommendations to be further reviewed at a later date. Martin Kulldorff, the ACIP's new chair, said two new work groups would be established, one focusing on the cumulative effects of children and adolescents receiving all recommended vaccines on the childhood immunization schedule and another reviewing vaccines that haven't been examined for more than seven years. The latter group may discuss whether the hepatitis B vaccine is necessary at birth before a baby leaves the hospital, according to Kulldorff. "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," Kulldorff said. The American Academy of Pediatrics put out a video on Wednesday, saying immunization policy through ACIP is "no longer a credible process" and that it will continue to publish its own vaccine recommendations for children. In the morning, CDC staff presented data on COVID-19 vaccines, showing safety and efficacy as well as a reduction in hospitalizations and deaths. For the 2024-25 updated COVID vaccine against emergency department and urgent care encounters, the CDC found 79% effectiveness for children between nine months and 4 years old, 57% effectiveness among children between five and 17 years old and 34% effectiveness for those aged 18 and older. Kulldorff asked where the data shows COVID-19 vaccine effectiveness from placebo-controlled trials. Dr. Adam MacNeil, from the CDC's National Center for Immunization and Respiratory Diseases (NCIRD), said the CDC's evaluation of effectiveness came from real-world data. "Randomized clinical control trials are not necessarily comparable to what we're currently seeing with the vaccine," MacNeil said. "Where we're trying to now monitor is the real-world impacts of these vaccines as opposed to clinical trial data, which was certainly extensively documented." The ACIP members also discussed questions about potential safety signals surrounding the COVID vaccine, with the CDC determining that myocarditis and pericarditis -- inflammation of the heart muscle and the sac around the heart, respectively -- are still risks, but no other risks have been found. The group also discussed RSV vaccines and antibody shots, but the committee delayed its vote on recommendations until Thursday. Currently, RSV vaccines are recommended for pregnant people between 32 and 36 weeks of pregnancy to pass on protection to a fetus, which should last throughout their first RSV season. For babies eight months and younger born to mothers who did not receive a maternal RSV vaccine, monoclonal antibody shots are available. Monoclonal antibodies are proteins manufactured in a lab and mimic the antibodies the body naturally creates when fighting an infection. They do not activate the immune system as would occur with vaccination. The shot is also recommended for a small group of children from 8 months old through 19 months old who are at increased risk for severe RSV. During the meeting, Dr. Georgina Peacock, director of the Immunization Services Division in the CDC's NCRID, shared CDC data showing 57% of infants born between April 2024 and March 2025 were protected from RSV by maternal vaccination or receipt of nirsevimab, one of the antibody shots. Dr. Cody Meissner, one of the new ACIP members, described the vaccine and antibody data, showing its real-world impacts as a "truly spectacular accomplishment." "People should understand this is a truly spectacular accomplishment and will have enormous impact on public health," he said. Another ACIP member, Retsef Levi, expressed some skepticism, saying he wanted to see more data on how efficacy for the maternal vaccine changes over time, adding that RSV is a "tricky" virus that "fools interventions in unexpected ways." In response, MacNeil of the NCRID said vaccine efficacy does wane over time, but the maternal RSV vaccine protects newborns and infants when they're at their most vulnerable, before they develop more robust immune systems. The group will vote on Thursday on whether to recommend a newer monoclonal antibody shot for babies eight months and younger and to update the resolution for the federal Vaccines for Children program to include details about the new, potentially approved antibody shot.
Yahoo
25-06-2025
- Health
- Yahoo
Kennedy-appointed CDC vaccine panel says it will scrutinize the childhood vaccine schedule
A federal vaccine advisory committee plans to review the childhood vaccination schedule and scrutinize vaccines that have been approved for decades, fueling concerns that the panel may consider changes to long-standing vaccine recommendations. On Wednesday, the newly appointed Advisory Committee on Immunization Practices convened for the first time. Earlier this month, Health Secretary Robert F. Kennedy Jr. fired all 17 members of the panel and appointed eight of his own, many of whom have expressed skepticism about the value and safety of vaccines. (One member, Dr. Michael Ross, has since withdrawn from the committee, Sen. Bill Cassidy, R-La., said Wednesday during a Senate hearing.) The independent panel of experts makes recommendations to the Centers for Disease Control and Prevention about who should get certain vaccines, which can in turn influence whether the vaccines are covered by insurance. The new committee chair, Martin Kulldorff — a biostatistician who criticized pandemic-era lockdowns and said he was fired from Harvard for refusing to get a Covid vaccination — struck a combative tone as the meeting began. 'Some media outlets have been very harsh on the new members of this committee, issuing false accusations and making concerted efforts to put scientists in either a pro- or anti-vaccine box,' Kulldorff said. 'Such labels undermine critical scientific inquiry, and it further feeds the flames of vaccine hesitancy.' Kulldorff also said that he opposed federal health agencies' decision to temporarily pause the rollout of Johnson & Johnson's Covid vaccine due to reports of rare blood clots in young women. 'There was a shortage of vaccines and people were dying, so I think that pause of the J&J vaccine was inappropriate,' Kulldorff said. 'So in that case, I was, I guess, the most pro-vaccine person among vaccine scientists in this country. So it's kind of a little bit ridiculous that then the media says that I am anti-vaccine.' He also announced the creation of two new work groups, subdivisions of the independent panel that review vaccine data and develop recommendation options to present at ACIP meetings. One will look at the cumulative effect of recommended childhood vaccines, including potential interaction effects between the shots. Another will re-evaluate vaccines that haven't been reviewed in more than seven years, Kulldorff said, including hepatitis B vaccines and a combination vaccine that protects against measles, mumps, rubella and varicella. 'This was supposed to be a regular practice of the ACIP, but it has not been done in a thorough and systematic way,' he said at the meeting. Kennedy has frequently criticized the childhood vaccination schedule, including the fact that children are vaccinated against far more diseases compared with decades ago. 'When I was a kid I got three vaccines,' Kennedy said Tuesday during a congressional hearing. 'Today they get 69 to 92 jabs of vaccines between conception and when they are 18 years old.' However, many vaccine experts argue that today's shots contain fewer antigens — the key components of vaccines that train the immune system to recognize the germ — compared with generations ago, and are therefore less taxing on the immune system. In announcing the new ACIP work groups on Wednesday, Kulldorff questioned some of the committee's past recommendations, including that hepatitis B vaccines should be given to newborns and that it's acceptable for 1-year-olds to receive a shot that combines the measles-mumps-rubella vaccine with the chickenpox, or varicella, vaccine. 'Unless the mother is hepatitis B positive, an argument could be made to delay the vaccine for this infection, which is primarily spread by sexual activity and intravenous drug use,' he said. The combination measles, mumps, rubella and varicella (MMRV) vaccine was approved in 2005 and the CDC initially recommended it be given to children at 12-15 months and again at ages 4 to 6. However, the CDC changed its guidance in 2009 after the first dose was linked to an increased risk of febrile seizures — convulsions caused by a spike in temperature — for every 2,300 to 2,600 vaccinated children. Now, the CDC recommends that young children are vaccinated with the MMR vaccine and the separate varicella vaccine for their first dose, and the combination shot be used for the second dose. However, the overall risk of febrile seizures is very low for both options, according to the agency. Kulldorff questioned a past ACIP recommendation that, for their first dose, children can get either the combination shot or separate varicella and MMR vaccines. He also said the working group 'may also look at new research concerning the optimal timing of the MMR vaccine to resolve religious objections that some parents have concerning the MMR vaccine being used here in the United States. They could also look at other MMR vaccines, such as the one used in Japan.' Over the next two days, the panel is slated to discuss updated data on anthrax, chikungunya, Covid and MMRV vaccines and vote on RSV and influenza vaccines. Recent Covid work group discussions presented Wednesday determined that updated Covid vaccines are suitable for pregnant women, babies ages 6 to 23 months, and children and adults ages 2 to 64 who are at high risk of exposure to Covid. Immunocompromised people older than 6 months and older adults ages 65 and up should get two doses of the updated shot, according to the work group discussions. The group also determined that healthy children and adults could talk with their doctors about getting an updated Covid vaccine. In May, Kennedy announced that the CDC was no longer recommending the vaccine for this group or pregnant women. In another presentation for Wednesday afternoon, a work group determined that the CDC should recommend clesrovimab, an antibody injection that can prevent RSV, for all infants less than 8 months old born during or entering their first RSV season. The group determined that the drug was effective at preventing severe RSV in young infants and had a favorable safety profile. However, it also noted that too few infants were included in the clinical trial to capture rare adverse events. The drug, from Merck, was approved by the Food and Drug Administration earlier this month. A similar drug, nirsevimab, is already approved and recommended for these infants. On Thursday, Lyn Redwood, an anti-vaccine activist, is set to give a presentation on thimerosal, a mercury-based preservative removed from all childhood vaccines — except for certain flu shots — in 2001. Redwood is the president emerita of Children's Health Defense, the anti-vaccine nonprofit group founded by Kennedy. She also co-founded SafeMinds, a group that funded research it hoped would show that thimerosal in vaccines was linked to autism. There is no evidence of such a link. The CDC's vaccine advisory committee is set to vote Thursday on whether thimerosal should remain in certain flu vaccines. Redwood's presentation claims that 'removing a known neurotoxin from being injected into our most vulnerable populations is a good place to start with Making America Healthy Again.' But there's no evidence that the low doses of thimerosal in flu vaccines are harmful, beyond some redness or swelling at the injection site. The preservative consists of ethylmercury, which is far less likely to accumulate in the body than mercury found in the environment. And the bulk of scientific evidence has shown that low doses in vaccines don't harm the nervous system. This article was originally published on
Politico
25-06-2025
- Health
- Politico
Kennedy's vaccine panel to review childhood immunization schedule
ATLANTA — At the first meeting of the CDC's panel of outside vaccine advisers since Health Secretary Robert F. Kennedy Jr. overhauled it with new members, the group said it will review childhood vaccines and shots not studied in more than seven years. The decision by the new group, tasked with reviewing the childhood immunization schedule, could open the door to changes on how and when children are immunized. The Advisory Committee for Immunization Practices' work groups study the latest vaccination data and develop recommendations for presentation to the committee. The work groups are mainly made up of CDC scientists and ACIP members, and can also include ACIP ex-officio members, ACIP liaison representatives, and consultants. — Details: ACIP Chair Martin Kulldorff said the committee would maintain existing work groups tasked with examining vaccines including shots for Chikungunya, influenza and mpox. New work groups will also be established, he said, including one to examine the cumulative childhood vaccine schedule as well as the adolescent schedule. 'In addition to studying and evaluating individual vaccines, it is important to evaluate the cumulative effect of the recommended vaccine schedule,' Kulldorff said Wednesday, the first day of a two-day meeting at CDC headquarters in Atlanta. 'This includes interaction effects between different vaccines, the total number of vaccines, cumulative amounts of vaccine ingredients, and the relative timing of different vaccines.' A CDC work group will also look at vaccines that have not been studied in more than seven years, he said. 'This new vaccine group may look at the universally recommended hepatitis B vaccine at the day of birth,' Kulldorff said. 'This working group may also look at new research concerning the optimal timing of the MMR vaccine to resolve religious objections that some parents have concerning the MMR vaccine being used here in the United States, it could also look at other MMR vaccines, such as the one used in Japan,' he added. — Key context: The work groups align with Kennedy's priorities on vaccines. He has long questioned the safety of several vaccines that children receive. But public health experts have criticized Kennedy for the push, arguing the U.S. has a strong vaccine safety monitoring system and that vaccines have saved many lives.
