Friday, a key federal advisory panel capped two days of confusing and often tense discussion on several new vaccine recommendations.
Public health experts and doctors say the panel's chaotic voting process and changes to vaccine recommendations will sow confusion and doubt among patients and parents, and this, in turn, could erode confidence in vaccines. Further, the panel's recommendations will narrow the public's vaccine choices, they said.
After two days of lengthy debate, the Centers for Disease Control and Prevention's (CDC’s) Advisory Committee on Immunization Practices (ACIP) ultimately decided to scrap one vote, reversed another and, in one of four votes on COVID-19 vaccines, stopped just short of an endorsement that had the potential to significantly impede access for many people living in the U.S., Fierce Pharma reported.
The ACIP members, all handpicked by Department of Health and Human Services Secretary Robert F. Kennedy Jr., met to vote on several new vaccine recommendations, including for mumps, measles, rubella and varicella (MMRV); hepatitis B virus (HBV); and COVID-19.
The members voted not to recommend the combined MMRV vaccine for any patient under 4 years old, reversing current guidance. The recommendation leaves room for children to receive an MMR shot and a varicella vaccine separately as their first dose in a two-vaccine sequence.
"Health shouldn't be a political issue, and it shouldn't depend on whether you live in a red state or a blue state. We should be doing the best things we can to keep you and your children healthy, wherever you live." —Andrew Pavia, M.D., chief of the Division of Pediatric Infectious Diseases at the University of Utah
The ACIP was also set to vote on whether to uphold universal HBV vaccination recommendations for infants at birth. The committee members discussed on Thursday moving the first dose of the HBV vaccine from birth to 30 days, but the question was tabled until Friday, and then they ultimately scrapped the vote.
With regard to the COVID-19 vaccine, ACIP members recommended that COVID-19 vaccinations should be based on "individual-based decision making," which means patients should speak with a clinician about the risks and benefits first.
This recommendation is actually broader than the Food and Drug Administration's approach, which restricts the vaccine's use for people ages 65 and older as well as adults and children over 6 months who have risk factors for developing severe COVID-19. But the ACIP's recommendation is narrower than some professional organizations'.
For the MMRV vaccine, ACIP members cited data presented by the CDC Immunization Safety Office showing a small increase in risk of febrile seizures after MMRV vaccination after the first dose, which is currently recommended at 12 to 15 months of age. In comparison, there is no evidence of an increased risk of febrile seizures with MMRV vaccination in children ages 4 to 6, when the second dose is recommended.
The ACIP’s recommendations still need to go before the CDC for final approval.
Medical associations and scientific experts have sounded the alarm about the newly revamped ACIP, saying the new committee members ignore expert input, focus on questionable or preliminary data and don't follow the established process for developing new vaccine recommendations.
The American Medical Association noted in a Friday statement that the ACIP's new processes and recommendations "leave parents confused about how best to protect their kids and unable to choose the combined MMRV vaccine for children under 4 years old."
The organization continued that it's "concerned that this change not only reduces parental choice, but also reflects ACIP’s reliance on selective data in forming its guidance."
"The meeting on Thursday and Friday was a clear departure from standard operating procedures," Helen Chu, M.D., a professor of medicine at University of Washington School of Medicine and a former ACIP member, told reporters during a media briefing hosted by the Infectious Diseases Society of America (IDSA) on Tuesday. "It's not clear how the agenda items were chosen and why the committee made the decision to readdress two safe and effective vaccines, hepatitis B and measles, mumps, rubella and varicella, that had already been approved and used for many decades in the United States, or to change the recommendation for the COVID-19 vaccine."
"Much of the discussion was focused on safety data. Rather than using the summary of evidence that was presented by CDC scientists, the ACIP members instead focused on a small set of trials with a set of adverse events, essentially cherry-picking the data rather than looking at the big picture," said Chu, who is an IDSA fellow. "They did not discuss all the other components that we think about when voting, the burden of disease, the acceptability, the logistics or the cost, all of which are critically important when you implement a vaccine in practice."
Chu added, "Ultimately, what these proceedings created was a sense of chaos and a sense of lack of confidence and access to vaccines that are safe and prevent disease for the American public."
Katelyn Jetelina, Ph.D., an epidemiologist, data scientist and author of the popular newsletter “Your Local Epidemiologist," said the MMRV changes to vaccine policy will be "disruptive."
"Roughly 15–30% of pediatricians stock the combination vaccine for first doses, and switching supply chains and clinic workflows takes time—even as long as 6 months. That lag could mean gaps in vaccination and missed opportunities," Jetelina wrote in her newsletter.
Long term, the overall population impact is likely small, Jetelina wrote. "Most providers already avoid MMRV for first doses, and the second dose remains unaffected," she said.
Friday, the American College of Emergency Physicians (ACEP) voiced its strong support for the use of "high-quality, evidence-based vaccine schedules as an essential component of public health and patient safety. "
The "ACEP formally endorses the most current consensus-based vaccine guidelines and schedules as developed and published by leading medical societies, including the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the American College of Obstetricians and Gynecologists (ACOG)," the organization said.
With regard to COVID-19 vaccines, the ACIP voted to maintain access to COVID-19 vaccination for everyone 6 months and older. COVID vaccines also will continue to be covered by insurance.
Pharmacists can provide vaccines in all 50 states using shared clinical decision-making, according to Jetelina.
However, the panel's shift from recommending widespread vaccination to recommending shared clinical decision-making creates an added barrier to people getting vaccinated, Harold Wimmer, president and CEO of the American Lung Association, said in a statement.
“This change adds a burden and causes confusion, and no science was presented to support this action," Wimmer said. “The American Lung Association strongly supports widespread vaccination, which is crucial for public health and this is especially true for respiratory viruses, including COVID-19."
COVID-19 remain a significant public health threat, Wimmer noted. From Oct. 1, 2024, through Sept. 13 of this year, there were 370,000 to 530,000 COVID-19 hospitalizations and up to 61,000 deaths.
Public health experts also voiced strong concerns about the newly revamped ACIP's process of conducting reviews and how it makes decisions.
During the two-day meeting, there were process violations, according to Jetelina, ranging from abandoning GRADE methodology (the standard system for evaluating medical evidence quality) without explanation to multiple vote reversals and ACIP members abstaining due to confusion.
“The evidence-based, transparent process for developing these recommendations has been disrupted," Wimmer said in a statement. "The ACIP has long been recognized for its rigorous scientific review and open deliberations. Unlike previous ACIP meetings, recent proceedings did not provide votes in advance, limiting the opportunity for public comment and scientific discussion. It is essential that ACIP return to its established role as a trusted, evidence-based body where careful analysis of the data and peer-reviewed science guide decision-making."
Andrew Pavia, M.D., chief of the Division of Pediatric Infectious Diseases at the University of Utah and an IDSA fellow, said the ACIP has abandoned "careful, comprehensive and transparent review that weighs all the factors that go into a recommendation."
"There was minimal participation of CDC experts, the secretary's office excluded representatives of liaison groups who care for patients and who have the relevant expertise. They made false claims about their justification for this exclusion. The rushed nature of the appointments of the new members, the lack of expertise and the lack of careful review of the data were striking and the effects were harmful," Pavia said during the IDSA media briefing.
In an unprecedented move, several states and medical societies are now breaking with the CDC's ACIP and are drafting their own vaccine recommendations. This fractures the longstanding national immunization policy and creates a patchwork of vaccine policies, noted Chu.
"This is not a sustainable process, because in order to be able to assess vaccine safety and how well it works in the community, you really need to be able to have real-time access to data, and this data comes in through national networks that are monitored by the CDC. ACIP meetings are really the time where this data is presented and decisions are made," she said. "It would be much better if we had a single trusted voice that was speaking for everyone and whose processes were totally transparent and up to the best standards."
"Health shouldn't be a political issue, and it shouldn't depend on whether you live in a red state or a blue state. We should be doing the best things we can to keep you and your children healthy, wherever you live," Pavia said.