Latest news with #AdvisoryCommitteeonImmunizationPractices
eNCA
16 hours ago
- Health
- eNCA
US panel replaced under Trump backs new shot for kids
WASHINGTON - A medical panel appointed by Health Secretary Robert F. Kennedy Jr. voted Thursday to recommend a new antibody treatment against RSV, a common respiratory illness that is the leading cause of hospitalization for infants in the United States. The vote marked the first by the Advisory Committee on Immunization Practices (ACIP) since Kennedy dismissed all members of the influential group of independent experts and replaced them with his own nominees, a move that made this decision a test of the new panel's intentions. Clesrovimab was recently approved by the Food and Drug Administration as a shot for newborns and young babies experiencing their first respiratory syncytial virus (RSV) season. Marketed under the name Enflonsia by its manufacturer Merck, it was shown in clinical trials to be safe and effective at significantly reducing RSV infections and hospitalizations among infants. The ACIP panel was asked to adjudicate the next step after approval -- namely, whether it should now be recommended for infants under eight months old entering their first RSV season who are not already protected by an RSV vaccine administered to their mother during pregnancy. They voted 5-2 in favor. The two dissenters were Retsef Levi, a professor of operations management at MIT who has questioned the safety of Covid-19 vaccines, and Vicky Pebsworth, a nurse and member of the anti-vaccine National Vaccine Information Center (NVIC). "I don't feel this is ready to be administered to all healthy babies. I think we should take a more precautionary approach," said Levi, explaining his "no" vote. Pebsworth did not offer comments, but the NVIC previously opposed the earlier-approved RSV antibody, nirsevimab.
Atlantic
a day ago
- Health
- Atlantic
‘I'm Not Quite Sure How to Respond to This Presentation'
The past three weeks have been auspicious for the anti-vaxxers. On June 9, Health Secretary Robert F. Kennedy Jr. purged the nation's most important panel of vaccine experts: All 17 voting members of the CDC's Advisory Committee on Immunization Practices (ACIP), which sets recommendations for the use of vaccines and determines which ones must be covered through insurance and provided free of charge to children on Medicaid, were abruptly fired. The small, ragtag crew of replacements that Kennedy appointed two days later met this week for the first time, amid lots of empty chairs in a conference room in Atlanta. They had come to talk about the safety of vaccines: to raise concerns about the data, to float hypotheses of harm, to issue findings. The resulting spectacle was set against a backdrop of accelerating action from the secretary. On Wednesday, Kennedy terminated more than $1 billion in U.S. funding for Gavi, a global-health initiative that supports the vaccination of more than 65 million children every year. Lyn Redwood, a nurse practitioner and the former president of Children's Health Defense, the anti-vaccine organization that Kennedy used to chair, was just hired as a special government employee. (She presented at the ACIP meeting yesterday.) A recently posted scientific document on the ACIP website that underscored the safety of thimerosal, an ingredient in a small proportion of the nation's flu vaccines, had been taken down, a committee member said, because the document 'was not authorized by the office of the secretary.' (A spokesperson for the Department of Health and Human Services told me in an email that this document was provided to the ACIP members in their meeting briefing packets.) What's clear enough is that, 61 years after ACIP's founding, America's vaccination policy is about to be recooked. Now we've had a glimpse inside the kitchen. The meeting started with complaints. 'Some media outlets have been very harsh on the new members of this committee,' said Martin Kulldorff, a rangy Swedish biostatistician and noted COVID contrarian who is now ACIP's chair. (Kuldorff was one of the lead authors of the Great Barrington Declaration, a controversial proposal from the fall of 2020 to isolate seniors and other vulnerable people while reopening the rest of society.) In suggesting that he and Kennedy's other appointees are opposed to vaccination, Kulldorff said, journalists were misleading the public, weakening trust in public health, and fanning 'the flames of vaccine hesitancy.' This was, in fact, the most pugnacious comment of the two-day meeting, which otherwise unfolded in a tone of fearmongering gentility. Robert Malone, a doctor and an infectious-diseases researcher who has embraced the 'anti-vaccine' label and published a conspiracy-theory-laden book that details government psyops against the American people, was unfailingly polite in his frequent intimations about the safety of vaccines, often thanking CDC staff for their hard work and lucid presentations. With his thick white beard, calm affect, and soldierly diction—Malone ended many of his comments by saying, 'Over' into the microphone—he presented less as a firebrand than as, say, the commanding officer of a submarine. When Malone alluded to the worry, for example, that spike proteins from the mRNA-based COVID vaccines linger in the body following injection, he did so in respectful, even deferential, language, suggesting that the public would benefit from greater study of possible 'delayed effects' of immune-system activation. The CDC's traditional approach—its 'world-leading, rigorous' one, he clarified—might be improved by examining this question. A subject-matter expert responded that the CDC has been keeping tabs on real-world safety data on those vaccines for nearly five years, and has not detected any signs of long-term harm. Later, Malone implied that COVID or its treatments might have, through some unspecified, bank-shot mechanism, left the U.S. population more susceptible to other illnesses. There was a 'paradoxical, sudden decrease' in flu cases in 2020 and 2021, he noted, followed by a trend of worsening harm. A CDC staffer pointed out that the decrease in flu during those years was not, in fact, a paradox; well-documented shifts in people's health behavior had temporarily reduced the load of many respiratory illnesses during that same period. But Malone pressed on: 'Some members of the scientific community have concern that they're coming out of the COVID pandemic—exposure to the virus, exposure to various countermeasures—there may be a pattern of broad-based, uh, energy,' he said, his eyes darting up for a moment as he said the word, 'that might contribute to increased severity of influenza disease.' He encouraged the agency to 'be sensitive to that hypothesis.' Throughout these and other questions from the committee members, the CDC's subject-matter experts did their best to explain their work and respond to scattershot technical and conceptual concerns. 'The CDC staff is still attempting to operate as an evidence-based organization,' Laura Morris, a professor at the University of Missouri School of Medicine, who has attended dozens of ACIP meetings in the past and attended this one as a nonvoting liaison to the committee from the American Academy of Family Physicians, told me. 'There was some tension in terms of the capacity of the committee to ask and understand the appropriate methodological questions. The CDC was trying to hold it down.' That task became more difficult as the meeting progressed. 'The new ACIP is an independent body composed of experienced medical and public health experts who evaluate evidence, ask hard questions, and make decisions based on scientific integrity,' the HHS spokesperson told me. 'Bottom line: this process reflects open scientific inquiry and robust debate, not a pre-scripted narrative.' The most vocal questioner among the new recruits—and the one who seemed least beholden to a script—was the MIT business-school professor Retsef Levi, a lesser-known committee appointee who sat across the table from Malone. A scruffy former Israel Defense Forces intelligence officer with a ponytail that reached halfway down his back, Levi's academic background is in data modeling, risk management, and organizational logistics. He approached the proceedings with a swaggering incredulity, challenging the staffers' efforts and pointing out the risks of systematic errors in their thinking. (In a pinned post on his X profile, Levi writes that 'the evidence is mounting and indisputable that mRNA vaccines cause serious harm including death'—a position entirely at odds with copious data presented at the meeting.) Shortly before the committee's vote to recommend a new, FDA-approved monoclonal antibody for preventing RSV in infants, Levi noted that he'd spent some time reviewing the relevant clinical-trial data for the drug and another like it, and found some worrying patterns in the statistics surrounding infant deaths. 'Should we not be concerned that maybe there are some potential safety signals?' he asked. But these very data had already been reviewed, at great length, in multiple settings: by the FDA, in the course of drug approval, and by the dozens of members of ACIP's relevant work group for RSV, which had, per the committee's standard practice, conducted its own staged analysis of the new treatment before the meeting and reached consensus that its benefits outweighed its risks. Levi was uncowed by any reference to this prior work. 'I'm a scientist, but I'm also a father of six kids,' he told the group; speaking as a father, he said, he personally would be concerned about the risk of harm from this new antibody for RSV. In the end, Levi voted against recommending the antibody, as did Vicky Pebsworth, who is on the board of an anti-vaccine organization and holds a Ph.D. in public health and nursing. The five other members voted yes. That 5–2 vote aside, the most contentious issue on the meeting's schedule concerned the flu shots in America that contain thimerosal, which has been an obsession of the anti-vaccine movement for the past few decades. Despite extensive study, vaccines with thimerosal have not been found to be associated with any known harm in human patients, yet an unspecified vote regarding their use was slipped into the meeting's agenda in the absence of any work-group study or presentation from the CDC's staff scientists. What facts there were came almost exclusively from Redwood, the nurse who used to run Kennedy's anti-vaccine organization. Earlier this week, Reuters reported that at least one citation from her posted slides had been invented. That reference was removed before she spoke yesterday. (HHS did not address a request for comment on this issue in its response to me.) The only one of Kennedy's appointees who had ever previously served on the committee—the pediatrician Cody Meissner—seemed perplexed, even pained, by the proceedings. 'I'm not quite sure how to respond to this presentation,' he said when Redwood finished. He went on to sum up his concerns: 'ACIP makes recommendations based on scientific evidence as much as possible. And there is no scientific evidence that thimerosal has caused a problem.' Alas, Meissner's warnings were for nought. Throughout the meeting, he came off as the committee's last remaining, classic 'expert'—a vaccine scientist clinging to ACIP's old ways—but his frequent protestations were often bulldozed over or ignored. In the end, his was the only vote against the resolutions on thimerosal. Throughout the two-day meeting, Kuldorff kept returning to a favorite phrase: evidence-based medicine. 'Secretary Kennedy has given this committee a clear mandate to use evidence-based medicine,' he said on Wednesday morning; 'The purpose of this committee is to follow evidence-based medicine,' he said on Wednesday afternoon; 'What is important is using evidence-based medicine,' he said again when the meeting reached its end. All told, I heard him say evidence-based at least 10 times during the meeting. (To be fair, critics of Kuldorff and his colleagues also love this phrase.) But the committee was erratic in its posture toward the evidence from the very start; it cast doubt on CDC analyses and substituted lay advice and intuition for ACIP's normal methods of assessing and producing expert consensus. 'Decisons were made based on feelings and preferences rather than evidence,' Morris told me after the meeting. 'That's a dangerous way to make public-health policy.'
Politico
2 days ago
- Health
- Politico
Vaccine panel's new path raises concerns
Driving the Day THE VIEW FROM ATLANTA — The CDC's revamped Advisory Committee on Immunization Practices wrapped up its first meeting Thursday, recommending use of a new monoclonal antibody for respiratory syncytial virus in infants and flu shots for everyone 6 months and older beginning this fall. But public health experts and former government officials said they were troubled by the tenor of the panel's vaccine discussions, as well as its move to recommend pulling a little-used preservative from the seasonal flu shot supply. Thimerosal's fate: ACIP voted to recommend against anyone — adult, child and pregnant person — receiving a seasonal flu vaccine with the mercury-containing compound, despite scientific consensus that it's not linked to severe adverse events or conditions like autism. Before the meeting, HHS Secretary Robert F. Kennedy Jr. questioned the safety of thimerosal on X, calling it a 'treadworn lie of the vaccine industry' that the compound is safe. In 2014, he wrote a book about thimerosal, arguing that it likely causes autism and should be banned. The real-world impact in the U.S. is minimal — just 4 percent of the supply last season contained thimerosal — but public health officials warn that even small percentages of a population-wide campaign matter. The multidose vials containing thimerosal are most likely purchased by state and local health departments or other entities that hold community-wide vaccination drives, potentially threatening access in low-income or rural areas. And beyond access, the suggestion that thimerosal is worth eliminating from the domestic seasonal vaccine supply could stoke vaccine hesitancy in low-income nations reliant on those products to reach as many citizens as possible. Multidose vials are also typically used in pandemics for the same access reason, and even though pandemic influenza vaccines weren't considered, a record of ACIP discouraging use of products containing thimerosal could hamper future immunization campaigns during health emergencies. Another RSV antibody: The committee's 5-2 vote recommending Merck's clesrovimab followed a tense debate among members about its benefits for otherwise healthy babies — despite ample data showing the virus can readily land those children in the hospital. Retsef Levi, an MIT business professor who voted against recommending it, focused on a nonstatistically significant increase in deaths among infants who got the immunization and questioned whether parents of healthy children would want to use it. But Dr. Cody Meissner, a Dartmouth pediatrics professor who's previously served on the ACIP and the FDA's vaccine panel, pushed back, noting it's impossible to predict which healthy children will avoid RSV's most severe consequences. 'If I were your pediatrician, I would strongly recommend that your wife either receive the RSV vaccine or a monoclonal antibody at birth,' Meissner said to Levi. Looking ahead: Lauren and POLITICO's Sophie Gardner, who was in the room at CDC headquarters, broke down the main takeaways from this week's meeting. IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. How about those Washington Wizards draft picks? Send your NBA thoughts and news tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA FDA LAYS OUT MDUFA PROCESS — The FDA announced Thursday In the Federal Register it will start the reauthorization process for its medical device user fee program by holding a public meeting on Aug. 4. People can 'present their views' on reupping the program through which industry pays fees to the agency to speed medical device reviews. Soon after, the agency says it will continue to meet with patient and consumer advocacy groups at least once a month while it negotiates with the medical device industry — with the first meeting to start by October. The FDA requests that people interested in participating in the meetings to notify the agency within 30 days. Why it matters: The notice is the latest sign the FDA will move to reauthorize its user fee programs despite HHS Secretary Robert F. Kennedy Jr.'s distaste for what he says are programs that allow industries to have a cozy relationship with the agency that regulates drugs and medical devices. Coronavirus UPDATED LABELING — The FDA formally posted a safety communication on Wednesday noting required updates to prescribing information for Pfizer's Comirnaty and Moderna's Spikevax Covid-19 vaccines to include the estimated unadjusted incidence of myocarditis and pericarditis following administration of the 2023-2024 shot. The agency also required the vaccine makers to add the results of a study that examined cardiac MRI findings in people who had developed myocarditis —an inflammation of the heart muscle — after receiving an mRNA Covid vaccine. Industry Intel NOVO'S NEXT MOVE — Fresh off a breakup with telehealth platform Hims, Danish drugmaker Novo Nordisk said Thursday it is partnering with WeightWatchers to distribute Wegovy via online mail orders at CenterWell Pharmacy. 'We will continue to pursue and build on agreements with companies that share our values and refine initiatives that help improve access to our FDA-approved medicines for patients,' Dave Moore, executive vice president of U.S. operations for Novo, said in a press release. In Congress THUNE: NO PARLIAMENTARIAN OVERRIDE — Senate Majority Leader John Thune said Thursday the Senate would not move to overrule its parliamentarian after she advised that including key provisions in the GOP's domestic-policy megabill would expose it to a fatal Democratic filibuster, POLITICO's Jordain Carney and Benjamin Guggenheim report. After the decisions — including provisions that would crack down on provider taxes states used to fund their Medicaid programs as well as measures meant to exclude undocumented residents from public benefits — were publicized Thursday, multiple conservative Republicans called on the Senate to sideline Parliamentarian Elizabeth MacDonough. But when asked by POLITICO about overruling her, Thune said, 'No, that would not be a good option for getting a bill done.' Republicans are expected to try to rewrite the provisions in hopes of winning MacDonough's blessing. The FDA announced import alerts on certain Olympus medical devices, including specific models of ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors, tied to concerns over quality system regulation violations. The FDA's Center for Drug Evaluation and Research released its annual drug trials snapshots summary report. The center approved 50 novel drugs in 2024. The FDA published guidance outlining how medical device manufacturers can submit cybersecurity information as part of premarket applications. It also published draft guidance on unique device identifier requirements for combination products. Eli Lilly is scheduled to meet with the White House Office of Information and Regulatory Affairs on Monday to discuss the Health Resources and Services Administration's 340B rebate guidance. WHAT WE'RE READING Eric Green, who led the National Human Genome Research Institute before being forced out of the NIH, still does not know who pushed him out, STAT's Anil Oza reports. The Supreme Court cleared the way for states to exclude Planned Parenthood from their Medicaid programs, Lauren and POLITICO's Alice Miranda Ollstein and Josh Gerstein write.
Miami Herald
2 days ago
- Health
- Miami Herald
Where do Americans stand on childhood vaccines as RFK Jr. shakes up CDC panel?
The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), and its eight new members, met for the first time Thursday after Health and Humans Services Secretary Robert F. Kennedy, Jr. announced a 'clean sweep' of the panel earlier this month. The change comes as infectious diseases like measles and whooping cough make major comebacks this year, and after the secretary said health agencies are facing 'a crisis of public trust.' The 17 previous members of the committee were 'retired' from their job of evaluating 'the safety, efficacy and clinical need of the nation's vaccines,' Kennedy said in a June 9 opinion piece in the Wall Street Journal, also posted on the HHS website. ACIP makes recommendations to the director of the CDC, who then can accept or deny the recommendations. The committee's decisions do not directly allow or prevent vaccines to be given, but they can impact health insurance coverage, NBC News reported. The panel said previously it would evaluate recommendations for childhood vaccines, according to the outlet, and members of the committee have had varying views on the regimen over the years. But where do most Americans actually stand on the childhood vaccine requirements? Majority of Americans support childhood vaccines The vast majority of U.S. adults support vaccines requirements as they currently stand, primarily as prerequisites to kids attending public school, a June 26 Harvard T.H. Chan School of Public Health poll found. The poll included 2,509 Americans over the age of 18, questioned between March 10 and March 31, and with margins of error between plus or minus 2.3 and 4.2 percentage points, according to the report. Overall, 79% of U.S. adults 'say parents should be required to have children vaccinated against preventable diseases like measles, mumps and rubella to attend school,' according to the survey. When broken down by political affiliation, 90% of Democrats and 68% of Republicans said they support the requirements, including 66% of adults who self-identified as part of the 'Make America Great Again' movement, the poll showed. Only 21%, or about one in five, said they didn't support the current requirements, data showed. 'Childhood vaccine requirements are less controversial than many people think,' Brian Castrucci, president and CEO of the de Beaumont Foundation, which collaborated on the poll, said in a news release about the poll. 'This poll shows that they're widely supported across political groups — and it's heartening to see that so many Americans understand the importance of vaccination, which remains a fundamental pillar of public health and disease prevention.' Opponents cite parental choice, political influence Kennedy said part of his reasoning for the ACIP shake-up was because the previous committee 'never recommended against a vaccine — even those later withdrawn for safety reasons.' But when it came to the poll results, of the 21% of adults who stated they didn't support the childhood vaccines, very few cited safety concerns. About three-fourths of those who don't support the shots said 'a major reason is that they think it should be the parents' choice whether to vaccinate their child,' according to the poll. Others said 'they think government agencies who enforce vaccine requirements are influenced too much by politics,' or that the requirements are made to benefit large companies and vaccine manufacturers, according to the report. Less than half of respondents who don't support the requirement noted safety as a major concern, the poll found. Overall, 88% of parents said they believe vaccines are safe, including 97% of Democrats, 88% of Republicans and 84% of 'MAGA' supporters, according to the poll. Few changes made in ACIP voting The HHS announced votes from the first meeting of the new ACIP, with decisions made on RSV recommendations and flu shots, according to a June 26 news release. The committee approved one dose of clesrovimab for infants not protected from respiratory syncytial virus (RSV) from their mothers, one of two monoclonal antibody products currently available. They also reaffirmed a previous recommendation for all people over the age of 6 months to receive an annual flu shot, including for pregnant women, according to the release. The committee said these shots, however, must be free of thimerosal, a mercury-based preservative used in vaccines since the 1930s that multiple U.S. and international studies have confirmed the safety of, according to the CDC. They also voted to update the 'Vaccines for Children Program' specifically for RSV prevention, the HHS said. 'Honesty, transparency and compassion with regard to public health. These are the three pillars that we, the new ACIP members, are guided by. Our central duty is to protect public health, and we understand that we must answer the call for reestablishing confidence in the scientific examination process. This committee strongly supports the use of vaccines, and other counter measures, predicated on evidence-based medicine, including rigorous evaluation and expansive credible scientific data, for both safety and efficacy,' the committee members said in a joint statement shared by the HHS.
2 days ago
- Health
Kennedy's vaccine committee to vote on flu vaccines and controversial preservative
ATLANTA -- U.S. Health Secretary Robert F. Kennedy Jr.'s new vaccine advisory committee backed another option to protect infants against a dangerous virus — before turning to questions about fall flu vaccines and a preservative in a small fraction of them that some antivaccine groups have falsely tied to autism. The Advisory Committee on Immunization Practices on Thursday took up protections against RSV, or respiratory syncytial virus, a common cause of cold-like symptoms that can dangerously inflame infants' tiny airways. 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. That first antibody, called nirsevimab, proved to be 63% to 76% effective against emergency department visits for infants over the last year. On Thursday, the vaccine panel voted 5-2 that another newly approved antibody shot, Merck's clesrovimab, should be used similarly. 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. 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. ___
