The chaos that marred the first day of a meeting of the federal vaccine committee, recently appointed by Health Secretary Robert F. Kennedy Jr., continued into its second day. The panel reversed a decision it had made and then indefinitely postponed a vote on a hepatitis B vaccine, which had already been deferred once.
On Friday morning, the committee voted against allowing a federal vaccine program to cover the cost of a combination vaccine that protects against measles, mumps, rubella, and varicella (chickenpox). This action rescinded a vote from Thursday that had approved coverage, apparently because some members had misunderstood the phrasing of the motion.
Furthermore, the panelists stated they felt unprepared to decide whether to restrict the use of a hepatitis B vaccine typically administered to all newborns. Some members expressed lingering safety concerns about the vaccine, while others appeared relieved that the panel refrained from making what they perceived as a hasty decision that could potentially harm children.
“We are more prudent when we are cautious,” remarked Dr. Joseph Hibbeln, a neuroscientist formerly with the National Institutes of Health, as he cast his vote to table the discussion.
Thursday’s session concluded with committee members in disagreement, with a hot microphone reportedly capturing one panelist referring to another as “an idiot.”
Friday’s meeting also saw moments of heightened tension, with raised voices and sharp exchanges. Dr. Jason Goldman, representing the American College of Physicians as a liaison to the committee, accused the chair, Martin Kulldorff, of muting him.
“You want debate and discussion, but you’re muting people and silencing them,” Dr. Goldman stated. “If you could respectfully inform the public how you plan to analyze all these vaccine decisions, we could have confidence in this committee.”
Dr. Kulldorff retorted, “You made that comment before, and I responded to that comment in a very nice and polite manner.”
The decisions made by this committee, currently convening at the Centers for Disease Control and Prevention in Atlanta, carry immense weight. Most private insurers are mandated to cover the vaccines it recommends, though they retain the option to cover others. Additionally, many state vaccine policies are directly linked to the committee’s guidelines.
At least some members appeared to align with Mr. Kennedy’s objective of implementing significant changes to routine childhood immunizations. For years, Mr. Kennedy has contended that children receive an excessive number of shots and has made unsubstantiated claims that current vaccines have not undergone proper testing.
The panelists’ indecisiveness highlighted the rushed manner in which Mr. Kennedy formed the committee. Most members are serving for the first time, and their lack of experience seemed to contribute to the confusion that overshadowed the meeting. Roughly half of the committee members were appointed just days before the session.
On Thursday, the committee initially voted to withdraw the MMRV vaccine’s recommendation for children under four. A separate vote concerned whether the Vaccines for Children program, which supplies shots to approximately half of American children, should continue to fund this vaccine. The committee initially approved continued coverage on Thursday but reversed that decision in a subsequent vote on Friday.
Such a contradictory outcome was unprecedented for the Advisory Committee on Immunization Practices, as was the decision to redo the vote the following day.
A core responsibility of the committee is to approve which vaccines the program should cover, yet some members seemed unaware of how their decisions would impact coverage. Several members expressed confusion about what they were voting on during Thursday’s session, with one abstaining for that very reason.
The members themselves seemed acutely aware of the unfavorable public perception.
While acknowledging the panelists possess “enormous depth and knowledge” about vaccines, Dr. Kulldorff conceded on Friday that they were “rookies” concerning the ACIP committee’s traditional decision-making processes.
In June, Mr. Kennedy removed all 17 previous members of the committee and appointed seven new members, many of whom share his skepticism about vaccines. He announced an additional five members earlier this week. Typically, ACIP members undergo months, sometimes years, of vetting before being invited to join.
Some medical organizations sharply criticized the committee for deviating from the ACIP’s usual protocols, which involve detailed discussions on feasibility, acceptability, cost-benefit analysis, and equity considerations.
Instead, the panelists were “distracted” by minor studies that raised safety concerns, noted Dr. Amy Middleman, head of pediatrics and adolescent medicine at Case Western Reserve University and a liaison to the committee from the Society for Adolescent Health and Medicine.
Every vaccine and medication carries inherent risks, she explained, but “the committee’s scientific challenge is to determine whether the benefits outweigh the risk.”
Public health experts specializing in hepatitis B expressed relief that the committee postponed the vote on that particular vaccine.
“Tabling the vote is appropriate and a relief,” commented Dr. Noele P. Nelson, a senior author of the current vaccine guidelines and a former leader of the CDC’s hepatitis vaccines work group.
“This discussion should not be rushed and would benefit from a more comprehensive evaluation of the public health impact,” she added.
Babies typically receive immunization for hepatitis B within 24 hours of birth. The committee was slated to vote on whether this shot should instead be advised only for newborns whose mothers are confirmed to be infected. For other infants, the motion suggested, immunization should occur only after they reach one month of age.
Hepatitis B experts highlighted that the vaccine has nearly eradicated maternal transmission of the disease in the United States, reducing its incidence to fewer than 20 cases annually, a drastic drop from approximately 20,000 cases per year before 1991.
They warned that delaying the initial dose of the vaccine would heighten the risk to newborns, as many cases in pregnant women go undetected despite longstanding recommendations for routine testing.
Infected women might also not be identified due to inaccurate test results or issues with reporting or interpreting them.
“A universal birth dose recommendation is the only way to ensure we don’t miss vaccinating newborns exposed to this virus, including those whose mothers were not tested during pregnancy,” emphasized Dr. John W. Ward, director of the Coalition for Global Hepatitis Elimination and a former head of the CDC’s viral hepatitis division.
Hepatitis B experts also questioned the panel’s emphasis on the vaccine’s safety, despite decades of data from millions of babies demonstrating its safety. Some committee members also expressed dissatisfaction with the overall discourse.
The discussion surrounding the hepatitis B vaccine’s potential harms was veering into “speculation,” Dr. Hibbeln remarked on Thursday, sounding visibly frustrated. “We need data on real risks and benefits.”
The committee is scheduled to vote on COVID-19 vaccines later on Friday and is widely expected to restrict access to those shots.