Latest news with #ACIP
Politico
6 hours ago
- Health
- Politico
RFK Jr.'s past claims shadow vaccine panel agenda
Presented by With help from Amanda Chu and Danny Nguyen Driving the Day ACIP AGENDA CHANGE — The agenda for next week's Advisory Committee on Immunization Practices meeting includes some notable differences from the notice posted in the Federal Register earlier this month, Sophie reports with POLITICO's Lauren Gardner. Most notably, the panel will hold two separate votes for the flu shot: one on influenza vaccines and another on influenza vaccines that contain thimerosal. In 2014, before he became health secretary, Robert F. Kennedy Jr. wrote a book in which he alleges the vaccine preservative thimerosal likely caused autism and should be banned — a claim that health agencies now under his control have said is unfounded. Thimerosal continues to be used as a preservative in multidose vaccine vials to inhibit germ growth. But its use in FDA-licensed flu vaccines has declined over the past 25 years as manufacturers reformulated their products and shifted to single-use vials. Most of those contain little or no thimerosal, according to the CDC. The meeting marks the first for Kennedy's revamped ACIP roster — following the firing of the previous 17 members — which includes several vaccine skeptics. No Covid vote: The agenda does not include a vote on Covid-19 vaccines, despite the Federal Register notice saying a vote is planned. Last month, Kennedy updated the CDC's Covid recommendations without a vote from the panel, breaking from tradition. Kennedy removed the recommendation that pregnant women get the shot, and the CDC changed the recommendation for healthy children to 'shared clinical decision making' — meaning children 'may' get vaccinated if their doctors and parents want them to. The HPV vaccine and meningococcal vaccine were also slated for a vote according to the meeting's Federal Register notice but aren't included in the draft agenda. Cut short? The agenda for the advisory committee's meeting includes only two days, June 25 and 26, but the initial Federal Register notice said the panel would also meet on June 27. A spokesperson for HHS did not comment on the thimerosal vote or why the agenda for the 27th wasn't included. WELCOME TO FRIDAY PULSE. For more on what next week's ACIP agenda holds, keep reading. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @Kelhoops and @sophie_gardnerj. Vaccines 'THEY CROSSED THE LINE' — Dr. Fiona Havers, a CDC scientist who collected and compiled data on Covid-19 and respiratory syncytial virus before stepping down this week, told POLITICO that HHS Secretary Robert F. Kennedy Jr.'s overhaul of the agency's outside panel of vaccine experts was her final straw. 'I knew at that point that they had crossed the line,' Havers said. 'As a physician and a scientist, and for my own personal integrity, I did not feel like I could stay and legitimize this process.' The Advisory Committee on Immunization Practices votes on vaccine recommendations, playing an integral role in developing childhood and adult vaccine schedules. Last week, Kennedy fired the entire panel and replaced them with members he hand-selected. The first meeting of the new members is scheduled for next week. Havers often presented data to the panel to inform its decisions. I spoke with Havers about her decision to resign and what she will be watching for at next month's meeting. Here's our conversation, edited for length and clarity. What made you resign? [It was a] culmination over the last one to two months of RFK Jr. trashing the vaccine policy recommendation process at CDC. This has been building for a while. Several events have really undermined the vaccine policy process. One was in late May, when FDA officials released this regulatory framework suggesting that only those 65 years older and people with underlying medical conditions should receive [updated] Covid-19 vaccines. Then the following week, the HHS secretary announced on X that the Covid vaccines for healthy children and healthy pregnant women had been removed from the CDC recommended vaccine immunization schedule … Basically, RFK Jr. was making CDC vaccine policy on X without involving CDC. And that was pretty shocking, because there's a very rigorous process in place. Then last week, when they announced the firing of all 17 ACIP members, I knew I was done. Can you share any thoughts on Kennedy's replacement picks? These people are, for the most part — with very few possible exceptions — not the people that should be sitting on ACIP. What will you be watching at the meeting next week? If CDC is presenting the data … the data coming out of CDC is still solid. As of now, I can speak to the fact that the COVID-NET and RSV-NET data is high-quality evidence and can be believed. How those data get used to make vaccine policy decisions is really what's in question right now. Seeing the kind of questions that they ask and what they say may give some clue as to how they may vote in the future. I am very concerned that there's going to be a restricting of access to vaccines for people that otherwise should be getting them, and we'll get some sense of if that's actually going to happen. HHS response: HHS spokesperson Andrew Nixon told POLITICO that HHS is 'committed to following the gold standard of scientific integrity,' and 'vaccine policy decisions will be based on objective data, transparent analysis and evidence — not conflicts of interest or industry influence.' AROUND THE AGENCIES GAIN-OF-FUNCTION CUTS — The National Institutes of Health is cutting and suspending funding for gain-of-function research, a move that will impact biomedical projects conducted globally, Danny reports. The NIH's directive, released Wednesday, will immediately terminate funding and other support for gain-of-function research conducted by 'foreign entities in countries of concern or foreign countries where there is no adequate oversight.' The order didn't explicitly name the targeted groups and countries. The NIH did not respond to a request for comment. The agency will also suspend funding and additional support for all other gain-of-function research and has asked researchers who receive NIH funds to identify other projects not yet identified by the agency that fit the category by June 30. Gain-of-function research involves genetically altering biological organisms to enhance transmission or other functions, which can help scientists identify therapeutic targets. Key context: The move comes months after the Trump administration marked gain-of-function research as dangerous. Earlier this year, the administration said the Covid pandemic was caused by a lab leak from gain-of-function research at a virology research institute in the Chinese city of Wuhan, where the virus first appeared. Many scientists, however, believe the disease was caused by natural spillover from an animal to a human. The Trump administration's theory, memorialized in a glossy website unveiled in April, prompted President Donald Trump to issue an executive order last month to eliminate federal funding for gain-of-function research in countries such as China, which Trump has criticized for inadequate research oversight. The NIH's latest missive delivers on this executive order. In other research news: The FDA announced Wednesday it would immediately review new clinical trials that 'involve sending American citizens' living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent.' The order, endorsed by the NIH, is another swipe at foreign research — particularly studies performed in China, which the administration has characterized as poorly regulated. Industry Intel BURR'S LOBBYING GIG — The Biotechnology Innovation Organization, the world's largest biotech organization, has tapped former Republican Sen. Richard Burr (R-N.C.) to lobby on issues related to drug pricing and supply chains, Medicare and Medicaid and reauthorization of the Pandemic and All-Hazards Preparedness Act, Amanda reports. Now health policy chair at law firm DLA Piper, Burr was the top Republican on the Senate Health, Education, Labor and Pensions Committee and was a champion of reforming the FDA. Jamie Gregorian, a former senior policy adviser at the FDA and assistant to Burr in the Senate, will also represent BIO at DLA Piper, according to the law firm's disclosure submitted today. The outside hire from BIO marks the third for the group this year and comes as the biotech industry faces a steep drop in investor funding amid President Donald Trump's cuts to regulatory agencies. Earlier this week, BIO hired former Trump White House adviser Matt Mowers and Trump's campaign deputy director Bill Killion, who both now work at Valcour, a Washington-based lobbying firm. WHAT WE'RE READING POLITICO's Jordain Carney and Robert King report that Senate Republican leaders are seeking ways to tamp down moderates' worries about the megabill's possible impact on rural hospitals. The New York Times' Roni Caryn Rabin reports on the Trump administration's travel restrictions impacting medical residents.
Yahoo
14 hours ago
- Business
- Yahoo
EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy
GSK plc GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and above. With the EMA accepting the application for review, a final decision from the regulatory body in Europe is expected in the first half of 2026. Arexvy is currently approved for the prevention of lower respiratory tract disease ('LRTD') caused by RSV in all individuals aged 60 years and above, as well as for high-risk individuals aged 50-59 years. GSK is currently seeking approval for the expanded use of Arexvy in adults aged 18 years and above in the United States and Japan. Year to date, shares of GSK have risen 20.8% against the industry's decline of 0.6%. Image Source: Zacks Investment Research Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world. However, sales of the vaccine have been lukewarm, mainly due to the revised recommendations for RSV vaccinations issued by the Advisory Committee on Immunization Practices ('ACIP') in June 2024. In June, the ACIP recommended the use of Arexvy for all adults aged 75 years and above. However, for adults aged 60-74 years, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. Arexvy generated sales worth £78 million in the first quarter of 2025, down 57% year over year due to lower demand in the United States. Pfizer's PFE Abrysvo is approved for the prevention of RSV-associated LRTD in all individuals aged 60 years and above, as well as in infants, through maternal immunization. PFE's Abrysvo is also approved for use in high-risk adults aged 18-59 years in the United States and Europe. Earlier this year, the ACIP recommended the expanded use of Arexvy and Abrysvo for use in adults aged 50-59 years who are at high risk for severe RSV disease. The updated ACIP recommendation lowers the recommended age for RSV vaccination from 60 years to 50 years for high-risk adults. The ACIP's recommendation is pending final approval by the director of the U.S. Centers for Disease Control and Prevention ('CDC') and the Department of Health and Human Services. Moderna's MRNA RSV vaccine, mResvia, was approved last year by the FDA and the European Commission to prevent RSV-LRTD in older adults aged 60 years and above. Last week, the FDA approved MRNA's mResvia for use in high-risk adults aged 18-59 years. Moderna is also working on expanding the vaccine's use in pediatric populations. We note that RSV vaccine sales have been weak across the industry for the 2024-2025 vaccination season due to the restrictive recommendation issued by the U.S. CDC last year for individuals in the 60-74 age bracket. mResvia generated sales worth $2 million during the first quarter of 2025, while sales of Pfizer's RSV vaccine, Abrysvo, fell 9% year over year to $131 million. GSK currently carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Atlantic
a day ago
- Health
- Atlantic
The Future of the HPV Vaccine Is Up in the Air
Until last week, the future of vaccination for human papillomavirus, or HPV, in the United States seemed clear. For several years, a growing body of evidence has suggested that just a single dose of the vaccine may be as effective as two are, offering decades of protection against the virus, which is estimated to cause roughly 700,000 cases of cancer each year. More than 50 other countries have already adopted the one-dose schedule, and many experts hoped that the U.S. might follow suit this year. The decision rests, primarily, on the deliberations of the Advisory Committee on Immunization Practices, a vaccine-advisory committee to the CDC. ACIP was initially expected to put to a vote, as early as next week, the questions of HPV-vaccine dosing and, simultaneously, whether to strengthen the recommendations that advise vaccination starting at 9 years of age. Several experts told me that they had tentatively expected both motions to pass, making HPV vaccination easier, cheaper, and quicker. The HPV vaccine is one of the most powerful vaccines ever developed: It is unusual among immunizations in that it durably prevents infection and disease at rates close to 100 percent. If it was deployed more widely, 'we could see the end of cervical cancer,' Kirthini Muralidharan, a global-health expert and HPV-vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, told me. That was before Robert F. Kennedy Jr., the nation's health secretary, abruptly dismissed all 17 members of ACIP. Among their replacements—each apparently handpicked by Kennedy—are several researchers who have spread misinformation about vaccines or been embroiled in litigation against vaccine manufacturers; at least one of the new members has exaggerated the harms of the HPV vaccine specifically. Now the anticipated votes on the vaccine, among other immunizations, have been removed from the proposed agenda for ACIP's coming meeting, leaving the fate of the vaccine far murkier. ACIP has, for decades, been one of the world's most respected expert panels on vaccines. The group's charter is to rigorously evaluate the evidence on the immunizations that the FDA has green-lighted. The advice it gives the CDC then helps devise the official immunization schedule that guides how insurers cover vaccines, how states mandate immunizations in schools, and how primary-care physicians advise their patients. Only under the rarest of circumstances has a CDC director rejected the committee's advice. Effectively, the members of ACIP 'decide who gets the vaccine, at what age, and how many doses,' Noel Brewer, a vaccine expert and health-behavior researcher at UNC Gillings School of Global Public Health, who served on ACIP until last week, told me. The group's rigorous, data-driven approach is a primary reason the HPV-dosing strategy has yet to change. In particular, the committee was awaiting formal results from a large clinical trial in Costa Rica that has been comparing dosing strategies in adolescent girls. So far, the data, recently presented at a cancer conference, suggest that one dose is just as effective as two, the current CDC-backed regimen. Earlier this year, the ACIP working group focused on HPV vaccines was leaning toward supporting the dose drop, Brewer, who was part of that group, told me. The proposal to routinely recommend the vaccine as early as 9 years of age, he added, seemed likely to pass, too. (Currently, the CDC allows for HPV vaccination as early as 9 years of age, but only actively recommends it starting at 11 years of age.) Those amendments to HPV-vaccination guidelines would make the shot simpler to get, for a wider range of children—which could dramatically increase its uptake, Gretchen Chapman, a health-psychology researcher at Carnegie Mellon University, told me: 'The more you can make getting vaccinated easy and convenient, the higher vaccination rates will be.' Only about 60 percent of 13-to-17-year-olds in the U.S. are up-to-date on their HPV shots —a gap that public-health experts consider a major missed opportunity. That the shot can almost perfectly prevent infection and disease for decades is 'like the fantasy we have of vaccines,' Brewer told me. Its rock-solid protection 'just keeps rolling.' But the new ACIP may see matters differently. Kennedy has yet to fill the committee's roster, but his initial picks include individuals who appear to have a beef with HPV immunization. One member, Vicky Pebsworth, co-wrote an analysis detailing adverse events following HPV vaccination for an anti-vaccine organization, which she serves on the board of. Another new member, Martin Kulldorff, provided expert testimony in cases against the drugmaker Merck over its Gardasil vaccine, the only HPV shot available in the U.S., and received thousands of dollars from plaintiffs who accused the company of downplaying the vaccine's risks. (A judge in North Carolina overseeing one of those cases ruled in favor of Merck; another, in Los Angeles, is going to trial later this year.) And Kennedy, an environmental lawyer, has himself been instrumental in organizing the litigation campaign against Merck—and has described Gardasil as 'the most dangerous vaccine ever invented.' (Under pressure from senators, Kennedy has said that he will relinquish any proceeds from these lawsuits to his son.) He has also falsely claimed that the HPV vaccine—which data show has dramatically reduced rates of cervical cancer in the U.S. and elsewhere—'actually increases the risk of cervical cancer.' (HHS, the CDC, Pebsworth, and Kulldorff did not respond to a request for comment.) At some point, the current ACIP might see fit to soften the existing guidelines, or even advise the CDC to remove the vaccine recommendations for certain groups. If it does, those decisions could prompt insurers to stop covering the vaccines, or disincentivize health-care providers from offering them to families. The committee could also remove the vaccine from the Vaccines for Children program, which provides shots to kids whose parents cannot afford them. (An initial agenda for the ACIP meeting scheduled to start on Wednesday initially included a recommendation vote for the HPV vaccine, as well as a vote on its status in Vaccines for Children; those items no longer appear in the CDC's draft agenda.) A few of the experts I spoke with raised the possibility that this new ACIP might still amend the HPV-vaccine recommendation to a single dose, but with a different rationale: not because the members are swayed by the data on its effectiveness, but because they'd support any option that cleaves a vaccine dose from the immunization schedule. Kennedy, too, seems likely to back such a move. 'Any window to roll back the number of times a child receives a vaccine injection? He's going to push for,' Alison Buttenheim, a behavioral scientist at Penn Nursing, told me. The net effect might at first seem the same: Fewer doses of the HPV vaccine would be on the schedule. But the reasoning behind a decision can matter just as much as the end result. Robert Bednarczyk, an epidemiologist and vaccine researcher at Emory University's Rollins School of Public Health, pointed out that, although much of the evidence so far has pointed toward one dose being enough, the case isn't yet a slam dunk: Some of the trials investigating the single-dose strategy are using different formulations of Gardasil, or non-Gardasil brands, which may perform differently. (The Costa Rica trial, notably, does include the same Gardasil recipe used in the U.S.) And some experts still wonder if the protection offered by a single shot may fade faster than a double-dose regimen—a more challenging aspect of vaccine protection to assess without many years of follow-up. If that's the case, prematurely dropping the second dose could later force the U.S. to add a shot back into the vaccine schedule—a confusing message that could erode trust. The last thing the country needs now is 'another hit to public confidence around vaccines,' Bednarczyk said. How Kennedy and his allies publicly justify these choices, then, matters quite a bit. Vaccines, on the whole, are now being billed by the government not as vital, lifesaving tools, but as unnecessary risks, deserving of additional scrutiny. Of the multitude of vaccines on the childhood-immunization schedule, many people already see HPV 'as the troublesome one,' Brewer told me. Its ability to prevent cancer has been underemphasized; some critics have stoked unfounded fears that, because the vaccine guards against a sexually transmitted virus, it will increase promiscuity. And unlike other vaccines recommended in the early adolescent years, such as the meningococcal vaccine and the Tdap booster—which are required by most or all states for entry into secondary school—HPV is mandated for preteens in only a handful of jurisdictions. All of these pressures make the vaccine more vulnerable to being rejected, Chapman told me. And should Kennedy's new vaccine team openly discard HPV doses primarily for the sake of dropping a shot, that could set a precedent—for removing other vaccines from the schedule, in part or entirely.
Medscape
a day ago
- Health
- Medscape
Senator, Medical Groups Request Inquiry Into ACIP Firings
Senator Bernie Sanders is calling for a congressional inquiry into the mass firing of all 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP). The Independent from Vermont issued his demand in a letter to Bill Cassidy, Louisiana Republican colleague and chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), which confirmed Robert F. Kennedy, Jr, as Health and Human Services secretary. 'Secretary Kennedy's reckless decision to fire these nonpartisan scientific experts and replace them with ideologues with limited expertise and a history of undermining vaccines will not only endanger the lives of Americans of all ages, it directly contradicts a commitment he made to you before he was confirmed that he would not make any significant changes to this important Committee,' wrote Sanders. Before voting to confirm Kennedy, Cassidy said in a Senate floor speech that the nominee had promised to work 'within the current vaccine safety and monitoring systems.' Cassidy added that Kennedy promised that if he was confirmed, the nominee said he would 'maintain the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices without changes.' As reported by Medscape Medical News , Kennedy fired the ACIP panel members on June 9, claiming that all had conflicts of interest. Even Cassidy expressed alarm after the firings, stating on X, 'now the fear is that the ACIP will be filled up with people who know nothing about vaccines except suspicion.' But Cassidy claimed that he would keep talking to Kennedy 'to ensure this is not the case.' Sanders has requested an immediate investigation into the firings and asked the Senate Committee on HELP to 'conduct serious oversight into the actions Secretary Kennedy has taken to mislead the American people about the safety and effectiveness of vaccines and erode public health.' The ACIP firings drew widespread condemnation from public health advocates and medical organizations. Many of those same organizations banded together to pass an emergency resolution at the American Medical Association's annual meeting in June that also backed a Senate investigation and called on Kennedy to reverse the firings. Kennedy also reportedly removed most of the ACIP staff, including Melinda Wharton, MD, MPH. Wharton joined the CDC in 1986 and became director of the CDC's National Center for Immunization and Respiratory Diseases in December 2013. She was replaced by the director of scheduling and advance in the CDC director's office, but there is still no acting CDC director. That new official now is under the direction of a political appointee, The Washington Post reported. Another CDC official, Fiona Havers, MD, who oversaw COVID data collection on the Respiratory Virus Hospitalization Surveillance Network team, also resigned in the wake of the firings, as reported by Medscape Medical News . Earlier in June, after Kennedy unilaterally changed the ACIP immunization schedule to remove guidance for COVID-19 vaccination for pregnant women and move to shared decision-making for healthy children, a top CDC leader in the COVID field, Lakshmi Panagiotakopoulos, MD, resigned. Panagiotakopoulos had been at the agency for almost a decade. Speaking out publicly, the former ACIP panelists wrote in JAMA , 'We are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of US immunization policy, impact people's access to lifesaving vaccines, and ultimately put US families at risk of dangerous and preventable illnesses.'
Korea Herald
2 days ago
- Health
- Korea Herald
Kennedy's panel to discuss measles shot
WASHINGTON (Reuters) — US vaccine advisers will discuss recommendations for flu vaccines containing the preservative thimerosal and a combination measles shot for children this month, putting topics of concern to Health Secretary Robert F. Kennedy Jr. high on the public health agenda. Kennedy, who has a long history of sowing doubt over the safety of vaccines, contrary to scientific evidence, wrote a book in 2014 claiming that thimerosal, a mercury-based preservative, causes brain damage. He has also prominently promoted the idea that vaccines that combine shots against measles, mumps and rubella, as well as varicella are linked to autism. Repeated scientific studies have disproved both assertions. Since taking the role of top US health official under the Trump administration, Kennedy is changing vaccine policies for the American public. He recently asked for a review of all data including for the measles shot, by far the best way to prevent infection with the highly contagious and sometimes deadly virus. The panel, known as the Advisory Committee on Immunization Practice, is due to meet on June 25 and 26. It will vote on the safety of flu shots and discuss proposed recommendations for use of the combined MMRV vaccine for children under 5 years of age, according to a draft agenda on Centers for Disease Control and Prevention's website on Wednesday. While the seasonal flu shot was expected to be on the meeting agenda, neither the topic of thimerosal nor the MMRV vaccine was anticipated. The meeting agenda did not specify who will be presenting data on either subject. The Department of Health and Human Services declined to comment on the record on why topics were added to the agenda or who would be making presentations. "It's not clear why thimerosal is up for a vote or discussion, unless the goal is to repeat an old anti-vaccine trope that the data does not support — that thimerosal in vaccines is harmful — and use it as a messaging point," said Dorit Reiss, a vaccine law expert at UC Law San Francisco. The committee will also vote on use of RSV vaccines, but not the next COVID-19 boosters, as originally expected, according to the agenda. Other expected votes were also removed. "The reason for the discussion of MMRV is also unclear, and the fact that the presenter is (yet to be named) raises questions," Reiss said. "Also interesting is what is not on the schedule. Why is there no vote on COVID-19 vaccines with the fall season coming up, and questions about who should get boosters?" The agenda was posted after Kennedy abruptly fired all 17 ACIP members and named eight new advisers, including several who have advocated against vaccines. "It's disappointing to see scarce public health resources used to rehash settled science," said recently fired ACIP member Noel Brewer. "Substantial research across decades has shown the safety of thimerosal as a preservative in vaccination." Thimerosal has long been used in the United States in vials of medicines and vaccines that contain more than one dose, according to the CDC. Aside from minor reactions such as redness and swelling at the injection site, there is no evidence of harm caused by the low doses of thimerosal in vaccines, the agency says. Combination vaccines to prevent infection with measles, mumps and rubella viruses are marketed in the United States by Merck and GSK. Merck also sells the ProQuad shot that includes protection against those three viruses and varicella. For children under age 4 years, the CDC currently recommends that most receive a first dose of an MMR vaccine and a separate varicella shot. For the second dose, and for children over 4, the CDC says the MMRV vaccine is generally preferred over separate shots.
