The federal vaccine committee, recently appointed by Health Secretary Robert F. Kennedy Jr., experienced a second day of disarray. The panel not only reversed a previous decision but also indefinitely delayed a vote on a hepatitis B vaccine, a decision that had already been postponed once.
On Friday, the committee decided against federal vaccine program coverage for a combination vaccine targeting measles, mumps, rubella, and chickenpox. This marked a reversal of their Thursday vote, which had initially approved coverage. The change came after some members admitted to misunderstanding the proposal’s wording.
Panel members expressed their unpreparedness to make a decision on whether to restrict the use of the hepatitis B vaccine, routinely administered to all newborns. Safety concerns were raised by some, while others welcomed the delay, seeing it as a safeguard against a potentially hasty decision that could negatively impact children.
“Caution leads to prudence,” stated Dr. Joseph Hibbeln, a neuroscientist formerly with the National Institutes of Health, as he cast his vote to defer the decision.
Thursday’s meeting concluded with palpable disagreement among panel members. A live microphone inadvertently captured one member referring to another as ‘an idiot,’ though the speaker remained unidentified.
Friday’s proceedings also saw moments of heightened tension, with raised voices and pointed comments. Dr. Jason Goldman, representing the American College of Physicians, publicly accused Chairman Martin Kulldorff of muting his microphone.
Dr. Goldman challenged, “You claim to want debate and discussion, yet you are silencing voices. If you could transparently explain to the public how these vaccine decisions are being analyzed, we could have confidence in this committee’s process.”
Dr. Kulldorff responded, reminding him, “You’ve raised that point previously, and I addressed it respectfully.”
The committee’s decisions, deliberated at the Centers for Disease Control and Prevention in Atlanta, carry immense weight. Their recommendations often dictate which vaccines private insurers must cover and influence numerous state-level immunization policies.
A number of committee members appeared to support Mr. Kennedy’s stated aim of significantly altering standard childhood immunization schedules. For years, Mr. Kennedy has falsely asserted that children are over-vaccinated and that current vaccines lack proper testing.
The visible indecision among panelists underscored the rushed manner in which Mr. Kennedy formed the committee. Many members, new to such a role, appeared inexperienced, contributing to the widespread confusion observed during the meeting. Approximately half of the committee had only been appointed days prior.
On Thursday, the committee initially voted to retract the M.M.R.V. vaccine’s recommendation for children under four. A subsequent vote concerned whether the Vaccines for Children program, which supplies immunizations to roughly half of American children, should continue to fund this particular shot. After approving coverage on Thursday, the committee reversed this decision in a new vote on Friday.
Such a contradictory outcome, followed by the unprecedented decision to redo the vote the following day, marked a first for the Advisory Committee on Immunization Practices.
While a primary role of the committee is to approve vaccines for federal program coverage, some members seemed unaware of the implications of their votes. On Thursday, several expressed confusion about what they were deciding, with one member abstaining due to this lack of clarity.
The committee members appeared visibly uncomfortable with the public perception of these events.
Dr. Kulldorff conceded on Friday that while the panelists possess “enormous depth and knowledge” of vaccines, their inexperience in typical A.C.I.P. decision-making processes made them “rookies.”
In June, Mr. Kennedy controversially dismissed all 17 existing committee members, subsequently appointing seven new ones, many of whom share his skeptical views on vaccines. Five more members were added just this week. Traditionally, A.C.I.P. members undergo a rigorous vetting process lasting months or even years before their appointment.
Medical organizations sharply criticized the committee for bypassing the established A.C.I.P. methodologies, which include thorough discussions on feasibility, acceptability, cost-benefit analysis, and equity considerations for any new decision.
Dr. Amy Middleman, head of pediatrics and adolescent medicine at Case Western Reserve University and a liaison to the committee, suggested that panelists were “distracted” by minor studies presenting safety concerns.
She emphasized that while all vaccines and drugs carry inherent risks, the committee’s scientific duty is to ascertain if the benefits ultimately outweigh those risks.
Experts in public health focusing on hepatitis B expressed satisfaction with the committee’s decision to postpone the vote on that specific vaccine.
“Deferring the vote is both appropriate and a relief,” commented Dr. Noele P. Nelson, a senior author of the current vaccine guidelines and a former lead of the CDC’s hepatitis vaccines work group.
She added that the discussion should proceed without haste and would gain from a more thorough assessment of its public health implications.
Newborns typically receive hepatitis B immunization within 24 hours of birth. The committee was slated to vote on a proposal to recommend this initial shot only for babies whose mothers were confirmed infected, with other infants receiving immunization only after reaching one month of age.
Hepatitis B specialists highlighted that the vaccine has almost eradicated maternal transmission of the disease in the U.S., dramatically reducing annual cases from approximately 20,000 before 1991 to fewer than 20 today.
They warned that postponing the vaccine’s first dose would elevate risks for newborns, as numerous cases in pregnant women go undiagnosed, even with established routine testing protocols.
Additionally, challenges such as inaccurate test results or issues with reporting and interpretation can lead to infected women remaining unidentified.
Dr. John W. Ward, director of the Coalition for Global Hepatitis Elimination and former head of the CDC’s viral hepatitis division, asserted, “A universal birth dose recommendation is essential to prevent missing newborns exposed to this virus, especially those whose mothers were not tested during pregnancy.”
Hepatitis B experts also expressed concern over the panel’s intense focus on vaccine safety, given extensive data from millions of infants over many years confirming its safety. Some committee members also voiced dissatisfaction with the overall discussion.
Dr. Hibbeln, visibly frustrated on Thursday, commented that discussions about the hepatitis B vaccine’s potential harms were becoming “speculative.” He urged, “We need concrete data on actual risks and benefits.”
Later on Friday, the committee is slated to vote on Covid-19 vaccines, with expectations that they will move to limit access to these immunizations.