Measles, mumps and rubella vaccine(Merck Sharp & Dohme)

Advisory Committee on Immunization Practices work groups act as subcommittees that are tasked with reviewing data to help inform the decisions of the federal vaccine panel’s voting members. While the first meeting of Robert F. Kennedy Jr.’s reshuffled Advisory Committee on Immunization Practices (ACIP) didn’t yield any votes Wednesday, comments from the panel’s new chair made it clear that changes could be coming for U.S. vaccine policy, especially as it pertains to kids.The ACIP, which helps guide the Centers for Disease Control and Prevention (CDC) on how best to implement approved vaccines, will create two new work groups to examine the cumulative effect of childhood vaccine schedules and assess shots that haven’t been subject to review in more than seven years, the committee’s newly appointed chair, Martin Kulldorff, Ph.D., said at the top of a two-day ACIP meeting that started Wednesday.ACIP work groups act as subcommittees that are tasked with reviewing data to help inform the decisions of the federal vaccine panel’s voting members. Prior to Wednesday, the ACIP counted 11 work groups among its ranks, including a group focused on combined child, adolescent and adult immunization schedules.“The number of vaccines that our children and adolescents receive today exceed 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.“In addition to studying and evaluating individual vaccines, it is important to evaluate the cumulative effect of the recommended vaccine schedule,” he added. “This includes interaction effects between different vaccines, the total number of vaccines, cumulative amount of vaccine ingredients and relative timing of different vaccines.”To that end, the ACIP will establish a dedicated work group to evaluate childhood and adolescent vaccine schedules, he explained.The move aligns with RFK Jr.’s frequent calls to investigate the number of vaccines children receive. During RFK Jr.’s first address to Department of Health and Human Services (HHS) employees in February, the noted vaccine skeptic told agency staffers that the newly minted Make America Healthy Again Commission would consider no topic off limits in its mission to determine the causes behind a “drastic rise in chronic disease” in the country. Among the topics on the table, RFK Jr. singled out childhood vaccine schedules and selective serotonin reuptake inhibitors as well as electromagnetic radiation, the herbicide glyphosate, microplastics and ultra-processed foods.Meanwhile, apart from the childhood vaccine schedule group, the ACIP will also convene a new work group to evaluate vaccines “that have not been subject to review in more than seven years,” Kulldorff said during Wednesday’s meeting.“This was supposed to be a regular practice of the ACIP, but it has not been done in a thorough and systematic way,” he explained. “We will change that. 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 to make sure that ACIP recommendations are optimal for both individuals and public health.”Kulldorff noted that, among other immunizations, the new group could look at hepatitis B shots given to infants at birth and whether it might be preferable to recommend separate measles, mumps and rubella (MMR) and varicella vaccines rather than a combination shot targeting all four maladies.The group may also consider “optimal timing of the MMR vaccine to resolve religious objections that some parents have,” Kulldorff added.As of Wednesday, it wasn't immediately clear whether the new work groups were fully staffed. ACIP work groups must be chaired by a committee member. RFK Jr. appointed eight new members to the ACIP roughly two weeks ago following his firing of all 17 former sitting members in early June. One of those eight members has already withdrawn from the panel and is no longer a voting member of the ACIP, an HHS spokesperson confirmed Wednesday.Some of RFK Jr.’s picks to fill out the ACIP immediately proved controversial given certain panelists’ skeptical views on vaccines and criticism of government policies during the COVID-19 pandemic. Still, Kulldorff stressed that collaboration between the new panelists and the CDC’s work groups is paramount.“While we may bring different perspectives on some issues, we look very much forward to working collaboratively with the current members of existing work groups, as well as with scientists here at CDC," Kulldorff said. “We share the same goal: the improvement of public health that can only be achieved through close collaboration, open discussions and, most importantly, with evidence-based medicine.”Wednesday’s meeting was something of a trial run for the new-look ACIP, and scheduling hiccups prevented the panel from delivering a planned vote on infant respiratory syncytial virus (RSV) vaccine recommendations before the meeting adjourned for the day.After touching on RSV and COVID-19 vaccines during the first day, the panel will reconvene for Wednesday’s scheduled vote Thursday and dive into a number of other topics around immunizations for influenza, chikungunya, anthrax and more.In opening Wednesday’s meeting, Kulldorff—who co-authored an open letter criticizing lockdowns and other public health measures during the COVID-19 pandemic—was quick to address the controversy around federal health agency overhauls taking place under the second Trump administration.“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 explained. “Such labels undermine critical scientific inquiry, and it further feeds the flames of vaccine hesitancy.” That said, some medical organizations are already distancing themselves from the overhauled panel. Wednesday, the American Academy of Pediatrics (AAP) said it could no longer support the committee following the staff shake-up.“We won’t lend our name or our expertise to a system that is being politicized at the expense of children’s health,” AAP President Susan Kressly, M.D., said in a video posted on X. Instead, the organization will continue to publish its own immunization schedule as it has since the 1930s. 

The newly reconstructed CDC vaccine advisory panel will examine the cumulative effects of the childhood vaccine schedule, in addition to shots that members say haven’t been reviewed in “more than seven years.” The announcement, which came within the first hour of Wednesday’s Advisory Committee on Immunization Practices meeting, is a clear signal of what the new members will prioritize. It also speaks to vaccine safety concerns that have long been echoed by HHS Secretary Robert F. Kennedy Jr. “Secretary Kennedy has given this committee a clear mandate to use evidence-based medicine when making vaccine recommendations, and that is what we will do,” new ACIP chair Martin Kulldorff said in his opening statement. “Vaccines are not all good or bad.” The meeting marked the first since Kennedy fired all 17 members of the committee and replaced them with eight others. Some of those members have drawn ire from the scientific community, and at least one notable Republican senator, who feel they lack experience. One of those new members, Michael Ross, withdrew during the financial review process prior to the meeting, according to an HHS spokesperson. There has been a cloud of anxiety and anticipation leading into this meeting, as infectious disease stakeholders wondered how the committee might now veer away from longstanding priorities. Two newly proposed working groups hint at what those changes might be. Kulldorff said one of two new groups will assess the total number of vaccines on the childhood immunization schedule, interactions between different vaccines, the amount of ingredients in each, and the timing of the different shots. The other new working group will focus on vaccines that Kulldorff said deserve renewed assessment. “We have a duty and responsibility to keep up to date with scientific research to make sure that ACIP recommendations are optimal for both individuals and public health,” Kulldorff said. Without presenting any data, Kulldorff said this sub-panel may assess the administration of the hepatitis B vaccine at birth, suggesting it may not be necessary unless the mother is positive for the disease. He also mentioned the working group might assess guidance for the MMRV vaccine, and that it could lean in favor of administering the MMR and varicella separately. The timing of the MMR vaccine may also be assessed to accommodate specific religious concerns, Kulldorff said. “While we may bring different perspectives on some issues, we look very much forward to working collaboratively with the current members of the existing work groups,” Kulldorff said. It’s unclear who would lead these committees or contribute to them. The committee’s FDA liaison, Tracy Beth Høeg, disclosed that Pfizer and Moderna both added new details to their Covid vaccine labels expanding on the risk of myocarditis and pericarditis. The agency requested the additional details in letters to the companies sent last month. Prior to Høeg’s update, committee members questioned CDC presenters on the safety of the Covid vaccines and the agency’s safety monitoring systems. Panelist Robert Malone specifically asked whether they might be missing certain immunologic adverse events. Sarah Meyer, director of the CDC’s Immunization Safety Office, assured the panel that the agency has a durable and expansive process for catching adverse events. “If we were seeing any effects on organ systems, or safety concerns of any kind, we would be well-equipped to pick those up in our safety systems,” she said. Discussion of the Covid vaccines also focused on how the CDC conducts real-world efficacy trials. Kulldorff and fellow committee member Retsef Levi each questioned the adequacy of the test-negative study design for comparing vaccine efficacy. Levi suggested this kind of data collection runs the risk of missing whether the vaccines are making people more susceptible to other kinds of viruses, not just Covid. Ruth Link-Gelles, a CDC epidemiologist, said the test-negative strategy is meant to whittle down vaccine efficacy to populations of people who might be seeking treatment for Covid regardless of vaccination status. “We think that the controls here are exactly what we want to understand the relative impact of the vaccine,” she said.