In a unanimous decision on Friday, the federal vaccine committee, recently appointed by Health Secretary Robert F. Kennedy Jr., voted to restrict access to Covid-19 vaccines. Their recommendation states that adults aged 65 and above should only receive these shots after a thorough discussion of potential benefits and risks with a healthcare professional.
Similarly, the panel advised that individuals aged 6 months to 64 years should also consult a provider before vaccination. This recommendation, however, has created confusion regarding its alignment with the Food and Drug Administration’s existing authorization, which currently limits shots to adults over 65 and younger individuals with specific health concerns.
These combined decisions raise significant questions about the future of vaccine accessibility, particularly whether Americans will still be able to receive routine vaccinations at local pharmacies or if, in some areas, a doctor’s prior approval will become mandatory.
These pivotal votes occurred during the second day of a committee meeting, which saw a body hastily assembled by Mr. Kennedy. A majority of the panelists are new to such a role, and their lack of experience appeared to be a contributing factor to the disarray that overshadowed both days of discussions. Roughly half of the committee members had only been appointed earlier in the same week.
Although the recommendations from the Advisory Committee on Immunization Practices (ACIP) were not as stringent as some had anticipated, they are still expected to complicate the process for pharmacists in several states to administer vaccines to older adults. It’s worth noting that approximately two-thirds of Americans received their Covid-19 vaccine last year at either a pharmacy or drugstore.
Retsef Levi, the committee member leading the Covid work group, explained the rationale behind the proposed votes, stating, ‘We believe it’s appropriate for this to be a conversation between a physician or medical provider and a patient.’
He further clarified that the country is no longer considered to be in an ’emergency situation.’
Prior to these new recommendations, Mr. Kennedy had already moved to limit vaccine access for healthy pregnant women and healthy children. The Food and Drug Administration (FDA) had, in fact, authorized this year’s Covid-19 vaccine specifically for adults aged 65 and above, or for other adults managing particular medical conditions.
Additionally, the panel unanimously voted to advise the Centers for Disease Control and Prevention (CDC) to provide clear information about the risks associated with Covid-19 vaccines to both patients and healthcare providers. Currently, providers are already mandated by law to give patients a document detailing these risks and benefits.
However, the committee did not go as far as to approve a proposal that would have required a prescription for Covid-19 vaccines. This particular suggestion met with significant opposition among panelists, with several members highlighting that a large portion of the American population, especially in rural regions, lacks convenient access to a healthcare provider. Consequently, this proposal failed to pass.
Given that most committee members have publicly voiced opposition to Covid-19 vaccines or mandates in the past, their decision to restrict vaccine access was not altogether unexpected.
Nonetheless, the specific wording and nature of these restrictions caused concern among several public health experts.
Dr. Lakshmi Panagiotakopoulos, who previously led the CDC’s Covid-19 vaccine work group before her resignation in June, warned that ‘There will be preventable deaths that result from these decisions.’
She expressed her dismay, stating, ‘Having people without vaccine and clinical expertise having the power to harm so much of the public is unbearable,’ a clear reference to the committee members.
The chaotic atmosphere of the first meeting day carried over into the second, beginning with the panel’s morning vote against federal vaccine program coverage for a combination vaccine protecting against measles, mumps, rubella, and varicella (chickenpox).
This decision effectively overturned a previous vote from Thursday that had permitted such coverage, seemingly due to some members misunderstanding the original wording of the proposal.
Following this, the panel opted to indefinitely postpone a vote concerning the hepatitis B vaccine, which is usually administered to all newborns. Panelists indicated they felt unprepared to make a decision on potentially limiting its use.
While some members raised ongoing questions about the vaccine’s safety, others appeared relieved that the committee refrained from what they perceived as a hasty decision that could potentially endanger children.
Dr. Joseph Hibbeln, a neuroscientist and former National Institutes of Health expert, commented, ‘We are more prudent when we are cautious,’ as he cast his vote to table the discussion.
Thursday’s session concluded with palpable tension among the panel members. A live microphone inadvertently picked up one panelist referring to another as ‘an idiot,’ though the speaker’s identity remained unconfirmed.
Similarly, Friday’s proceedings occasionally escalated into heated exchanges and pointed comments. Dr. Jason Goldman, representing the American College of Physicians as a committee liaison, openly accused chairman Martin Kulldorff of suppressing his voice.
Dr. Goldman asserted, ‘You want debate and discussion, but you’re muting people and silencing them.’ He added, ‘If you could respectfully tell the public how you are going to be analyzing all of these vaccine decisions, we can have confidence in this committee.’
Dr. Kulldorff responded sharply, ‘You made that comment before, and I responded to that comment in a very nice and polite manner.’
The vote on Covid-19 vaccines was preceded by a contentious and deeply divided debate, during which numerous committee members raised doubts about the shots’ safety and efficacy.
During a discussion on vaccine protection against the virus, Dr. Natalie Thornburg, head of a CDC respiratory division, explained that antibodies generated by the vaccines are generally understood to offer protection.
However, fellow panelist Robert Malone countered that there is no definitive evidence establishing the precise antibody levels required for protection.
Dr. Malone emphatically stated, ‘You really have no right to assert what your feelings or opinions are about whether or not there’s a correlation between any of these outcomes. There is no established correlative protection for Covid, period, full stop, and stop saying otherwise.’
Dr. Fiona Havers, who resigned from the CDC in June after Mr. Kennedy dismissed all 17 previous ACIP members, expressed her dismay at the exchange. Dr. Havers is a frequent presenter at ACIP meetings.
Dr. Havers remarked, ‘I was shocked at how Robert Malone spoke to Dr. Thornburg, a well-respected leading scientist at CDC. That level of disdain for her expertise and lack of professionalism would not have been tolerated during ACIP meetings in the past.’
Several external experts also voiced their surprise and concern.
Dr. Anne Zink, a Yale University public health expert and former chief medical officer of Alaska, commented, ‘It was disheartening to witness continued personal attacks on scientists during the ACIP meeting rather than sticking to the data, the end goal, the health and well-being of the American people.’
During his presentation, Dr. Levi, leader of the Covid work group, asserted that evaluations of vaccine effectiveness were ‘based on very low-quality data and analyses’ and that vaccine-related injuries were ‘demonstrably not recognized.’
(Notably, his presentation slides, typically made available on the agency’s website, were instead provided to reporters by a health department spokesman during his talk.)
In stark contrast, CDC staff, representatives from major medical organizations like the American Medical Association, and other experts uniformly agreed on the safety and effectiveness of the vaccines.
Dr. Henry Bernstein, another member of the Covid work group, simply stated, ‘Or, if we don’t want to say effective, they work.’
Developed primarily under Operation Warp Speed, Covid-19 vaccines were considered a significant achievement of the first Trump administration, leading some lawmakers to suggest President Trump for a Nobel Peace Prize.
While Mr. Kennedy recently concurred in a Senate hearing that the former president merited such an honor, he has also controversially labeled the Covid-19 vaccine as the ‘deadliest’ ever created. For years, he has argued that children receive an excessive number of vaccinations and has made unsubstantiated claims that current vaccines were never adequately tested.
On Thursday, the committee also voted to withdraw its endorsement of the MMRV vaccine for children under four. However, in a separate but related vote, they paradoxically stated that the Vaccines for Children program, which supplies immunizations to approximately half of all American children, should continue to fund the vaccine’s cost.
This contradiction was unprecedented for the panel, as was their subsequent decision to rerun the vote on Friday.
A core responsibility of the committee is to approve which vaccines are covered by federal programs, yet it appeared some members were unaware of this fundamental duty.
During Thursday’s session, several members admitted they were unclear about the subject of their vote, with one explicitly abstaining due to confusion.
The members themselves seemed acutely aware of how their proceedings appeared to the public.
On Friday, Dr. Kulldorff conceded that while the panelists possess ‘enormous depth and knowledge’ regarding vaccines, they are effectively ‘rookies’ when it comes to the established decision-making protocols of the committee.
Several medical organizations strongly criticized the committee for deviating from the standard ACIP procedures, which traditionally involve thorough discussions on the feasibility, acceptability, cost-benefit analysis, and equity implications of their decisions.
Dr. Amy Middleman, head of pediatrics and adolescent medicine at Case Western Reserve University and a liaison from the Society for Adolescent Health and Medicine, noted that panelists were instead ‘distracted’ by minor studies presenting safety concerns.
She emphasized that while all vaccines and drugs carry inherent risks, ‘the committee’s scientific challenge is to determine whether the benefits outweigh the risk.’
Public health experts specializing in hepatitis B expressed satisfaction with the committee’s decision to postpone the vote on that particular vaccine.
Dr. Noele P. Nelson, a senior author of the current vaccine guidelines and former leader of the CDC’s hepatitis vaccines work group, remarked, ‘Tabling the vote is appropriate and a relief.’
She stressed that ‘This discussion should not be rushed and would benefit from a more comprehensive evaluation of the public health impact.’
Typically, babies receive the hepatitis B immunization within 24 hours of birth. The committee was slated to vote on a proposal to alter this, recommending the vaccine only for newborns whose mothers are confirmed to be infected, and for other infants, to delay immunization until they are at least one month old.
Hepatitis B specialists highlighted that this vaccine has been instrumental in virtually eradicating maternal transmission of the disease in the U.S., drastically reducing annual incidence from approximately 20,000 cases before 1991 to fewer than 20.
Dr. John W. Ward, director of the Coalition for Global Hepatitis Elimination and former head of the CDC’s viral hepatitis division, underscored the importance of the current protocol, stating, ‘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.’