A federal vaccine advisory committee, recently appointed by Health Secretary Robert F. Kennedy Jr., has voted to significantly restrict access to Covid-19 vaccines. Their unanimous decision recommends that all adults aged 65 and over should only receive these shots after a thorough discussion of the potential benefits and risks with a qualified health care provider.
For individuals aged 6 months to 64 years, the panel advised that vaccines could be administered following a similar consultation. However, this raises questions about how these recommendations align with the Food and Drug Administration’s existing authorization, which currently limits the shots to adults over 65 and younger individuals with specific health conditions.
These new directives create uncertainty, particularly regarding the ease of access to routine vaccinations. It’s now unclear whether Americans can still simply walk into pharmacies for their shots, or if a doctor’s permission will become a prerequisite in various states.
These pivotal decisions emerged from the second day of a hastily assembled committee meeting under Secretary Kennedy. The proceedings were reportedly marred by confusion, largely attributed to the inexperience of many panelists, with roughly half of the members being appointed just this week.
While the Advisory Committee on Immunization Practices (ACIP) recommendations were not as stringent as some anticipated, they are set to complicate the process for pharmacists to vaccinate older adults in certain states. Notably, a significant majority—about two-thirds—of last year’s Covid-19 vaccines were administered in pharmacies or drugstores.
Retsef Levi, who chaired the Covid work group and introduced these proposals, stated, "We believe it’s appropriate for these decisions to be made through a discussion between a physician or medical provider and their patient."
He further clarified that the country is no longer facing an "emergency situation."
Prior to these votes, Secretary Kennedy had already imposed restrictions on vaccine access for healthy pregnant women and children. The FDA’s current authorization for this year’s Covid-19 vaccine is limited to adults 65 and older, or those with specific underlying medical conditions.
Additionally, the panel unanimously recommended that the Centers for Disease Control and Prevention (CDC) clearly outline the risks associated with Covid-19 vaccines for both patients and health care providers. This is despite existing legal requirements for providers to offer patients a document detailing these risks and benefits.
However, the committee chose not to pass a more radical proposal that would have mandated prescriptions for Covid-19 vaccines. This idea faced strong opposition, with panelists highlighting that many Americans, especially in rural areas, lack easy access to healthcare providers, making such a requirement impractical.
Given that a majority of the committee members have openly expressed skepticism or opposition to Covid-19 vaccines and mandates, their move to restrict access was largely anticipated.
Nonetheless, the specific wording and nature of these restrictions have raised significant alarm 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 "preventable deaths will result from these decisions."
Referring to the newly appointed panelists, she further stated, "It is unbearable to see individuals lacking vaccine and clinical expertise wield such power, potentially harming a vast portion of the public."
The turbulent nature of the first day’s session spilled over into the second. In a morning vote, the panel initially decided against allowing a federal vaccine program to cover the cost of the MMRV combination vaccine, which protects against measles, mumps, rubella, and chickenpox.
This decision shockingly reversed a previous vote from Thursday that had approved coverage, with some members later admitting they had misunderstood the proposal’s wording.
Later, the panel opted to indefinitely postpone a vote concerning the hepatitis B vaccine, routinely administered to all newborns. Members expressed their unpreparedness to make a decision on potentially limiting the shot’s use.
While some voiced lingering safety concerns, others expressed relief that the committee avoided what they perceived as a hasty decision that could negatively impact children’s health.
Dr. Joseph Hibbeln, a neuroscientist and former NIH member, remarked, "We are more prudent when we are cautious," as he voted to defer the matter.
Thursday’s session concluded with palpable tension among the panelists, highlighted by a live microphone capturing one member referring to another as "an idiot," though the speaker remained unidentified.
Friday’s meeting also saw moments of heated exchange and pointed comments. Dr. Jason Goldman, representing the American College of Physicians as a committee liaison, openly accused Chairman Martin Kulldorff of silencing him.
Dr. Goldman challenged, "You claim to want debate and discussion, yet you are muting and silencing people. If you could respectfully explain to the public your analytical process for these vaccine decisions, we could have confidence in this committee."
Dr. Kulldorff responded sharply, "You have made that comment previously, and I addressed it in a very nice and polite manner."
The vote on Covid-19 vaccines was preceded by a deeply contentious and polarized debate, during which numerous committee members voiced doubts about the safety and efficacy of the shots.
During a debate on whether the vaccine offered protection against the virus, Dr. Natalie Thornburg, head of a CDC respiratory division, explained that antibodies generated by the vaccines were widely believed to be protective.
However, fellow panelist Robert Malone countered, stating there was no definitive evidence to establish the specific antibody levels required for protection.
Dr. Malone asserted, "You have no right to state your feelings or opinions on whether a correlation exists between these outcomes. There is no established correlative protection for Covid-19, full stop, and you should cease claiming otherwise."
Dr. Fiona Havers, who resigned from the CDC in June following Secretary Kennedy’s dismissal of all 17 previous ACIP members, expressed her dismay at the exchange. Dr. Havers has a history of presenting at ACIP meetings.
"I was shocked by Robert Malone’s tone with Dr. Thornburg, a highly respected CDC scientist," Dr. Havers commented. "Such disrespect for her expertise and unprofessional conduct would have been unacceptable in past ACIP meetings."
Several external experts also voiced their astonishment.
Dr. Anne Zink, a public health expert from Yale University and former chief medical officer of Alaska, found it "disheartening to witness persistent personal attacks on scientists during the ACIP meeting, instead of focusing on data and the ultimate goal of safeguarding the health and well-being of the American people."
During his presentation, Dr. Levi claimed that assessments of vaccine effectiveness were "based on very low-quality data and analyses" and that vaccine injuries were "demonstrably not recognized."
(It’s worth noting that his presentation slides, typically made public on the agency’s website, were instead provided to reporters by a health department spokesman during his talk.)
In stark contrast, CDC staff members and representatives from leading medical organizations, including the American Medical Association, along with other experts, consistently affirmed 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."
The Covid-19 vaccines, largely developed under Operation Warp Speed, were seen as a significant achievement of the first Trump administration, leading some to suggest President Trump for a Nobel Peace Prize.
While Secretary Kennedy acknowledged in a recent Senate hearing that the former president deserved this honor, he has also controversially labeled the Covid-19 vaccine as the "deadliest" ever created. For years, Kennedy has asserted that children receive an excessive number of vaccinations and has falsely claimed that current vaccines were not adequately tested.
On Thursday, the committee also rescinded its endorsement of the MMRV vaccine for children under four. Yet, paradoxically, in a subsequent vote, they affirmed that the Vaccines for Children program, which covers immunizations for approximately half of all American children, should continue to fund the shot.
This glaring contradiction was unprecedented for the panel, as was their subsequent decision to re-vote on the matter on Friday.
Despite the critical role of the committee in determining which vaccines federal programs cover, it appeared some members were unaware of this fundamental responsibility.
On Thursday, multiple members admitted they were unsure what they were voting on, with one explicitly abstaining due to sheer confusion.
The panelists themselves seemed acutely aware of the unfavorable public perception these actions created.
Dr. Kulldorff admitted on Friday that while the panelists possess "enormous depth and knowledge" about vaccines, they are "rookies" in the established decision-making processes of the committee.
Leading medical organizations sharply criticized the committee for deviating from standard ACIP procedures, which traditionally involve in-depth discussions on feasibility, public acceptability, cost-benefit analysis, and equity considerations before making decisions.
Instead, Dr. Amy Middleman, head of pediatrics and adolescent medicine at Case Western Reserve University and a liaison to the panel, noted 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 responsibility is to determine if the benefits genuinely outweigh those risks."
Public health experts specializing in hepatitis B expressed satisfaction with the committee’s decision to postpone the vaccine vote.
Dr. Noele P. Nelson, a senior author of current hepatitis B vaccine guidelines and former head of the CDC’s hepatitis vaccines work group, stated, "Tabling the vote is appropriate and a relief."
She added that "this discussion should not be rushed and would greatly benefit from a more comprehensive evaluation of its potential public health impact."
Currently, infants are routinely vaccinated against hepatitis B within 24 hours of birth. The committee was slated to vote on a proposal to recommend the vaccine only for newborns whose mothers are known to be infected, suggesting other infants wait until at least one month old.
Hepatitis B specialists highlighted that the vaccine has been instrumental in almost eradicating maternal transmission of the disease in the U.S., dramatically reducing annual cases from approximately 20,000 before 1991 to fewer than 20 today.
Dr. John W. Ward, director of the Coalition for Global Hepatitis Elimination and former head of the CDC’s viral hepatitis division, emphasized, "A universal birth dose recommendation is the only way to guarantee that no newborns exposed to this virus are missed, especially those whose mothers were not screened during pregnancy."