A federal vaccine committee, recently appointed by Health Secretary Robert F. Kennedy Jr., made a unanimous decision on Friday to tighten access to COVID-19 vaccines. Their new recommendation states that adults aged 65 and over should only receive the shots after a detailed discussion of the potential benefits and risks with a healthcare professional.
The committee further suggested that individuals between 6 months and 64 years old should also consult a provider before vaccination. However, this raises questions about potential conflicts with the Food and Drug Administration’s existing authorization, which currently limits these shots to adults over 65 and younger individuals with specific health conditions.
These combined decisions create significant uncertainty, leaving many Americans wondering if they can still easily obtain routine vaccinations at local pharmacies, or if, in certain states, a doctor’s referral will now be a prerequisite.
The votes were cast on the second day of the committee’s hastily arranged meeting. A notable lack of experience among the newly appointed panelists, with roughly half having been selected just this week, appeared to fuel the disarray and confusion that characterized both days of deliberations.
While the recommendations from the Advisory Committee on Immunization Practices (ACIP) were not as stringent as some anticipated, they are expected to complicate the process for pharmacists in several states who administer vaccines to older adults. Notably, about two-thirds of all COVID-19 vaccinations last year were administered in pharmacies or drugstores.
Retsef Levi, a committee member who chaired the COVID-19 work group and presented the proposed changes, stated, “We believe it’s appropriate for these discussions to occur between a physician or medical provider and their patient.”
He further emphasized that the nation is no longer in an “emergency situation” regarding the pandemic.
Prior to these new recommendations, Mr. Kennedy had already taken steps to limit vaccine access for healthy pregnant women and children. The FDA had previously authorized this year’s COVID-19 vaccine specifically for adults 65 and older, or those with particular underlying health conditions.
In another unanimous vote, the panel recommended that the Centers for Disease Control and Prevention (CDC) issue guidance on the risks associated with COVID-19 vaccines for both patients and healthcare providers. Current regulations already mandate that providers furnish patients with information sheets detailing these risks and benefits.
However, the committee ultimately decided against a proposal that would have required a prescription for COVID-19 vaccines. This particular recommendation sparked considerable debate among panelists, with several highlighting that a large portion of the American population, especially those in rural communities, lack easy access to healthcare providers. Consequently, the proposal failed to pass.
Given that a majority of the committee members have openly expressed skepticism or opposition to COVID-19 vaccines and mandates, their decision to restrict vaccine access was largely anticipated.
Despite the anticipation, the precise wording and nature of these new restrictions caused significant alarm among many public health experts.
“These decisions will undoubtedly lead to preventable deaths,” warned Dr. Lakshmi Panagiotakopoulos, who previously led the CDC’s COVID-19 vaccine work group before her resignation in June.
Referring to the committee members, she added, “It is unbearable to see individuals without adequate vaccine and clinical expertise wielding such power to potentially harm a large segment of the public.”
The disorganization and confusion from the first day of the meeting continued into the second. In the morning session, the panel initially voted against federal vaccine program coverage for a combination vaccine that protects against measles, mumps, rubella, and varicella (chickenpox).
This vote controversially reversed a decision made on Thursday to approve coverage, a reversal reportedly due to some members misunderstanding the original wording of the proposal.
Later, the panel decided to indefinitely postpone a vote on the hepatitis B vaccine, typically administered to all newborns. Committee members expressed their unpreparedness to make a decision regarding potential limitations on the use of this vaccine.
While some panelists voiced ongoing concerns about the vaccine’s safety, others appeared relieved that the committee refrained from making what they perceived as a hasty decision that could potentially endanger children.
“Prudence is found in caution,” remarked Dr. Joseph Hibbeln, a neuroscientist and former National Institutes of Health member, as he cast his vote to table the discussion.
Thursday’s session concluded with palpable tension among the panelists, highlighted by an incident where an open microphone captured one member disparaging another as “an idiot,” though the speaker remained unidentified.
Friday’s meeting similarly saw moments of heated exchanges and pointed comments. Dr. Jason Goldman, representing the American College of Physicians as a committee liaison, publicly accused chairman Martin Kulldorff of silencing him.
“You claim to seek debate and discussion, yet you mute and silence individuals,” Dr. Goldman asserted. “If you could transparently explain to the public how these vaccine decisions will be analyzed, we might be able to trust this committee.”
Dr. Kulldorff responded sharply, “You made that same comment previously, and I addressed it in a very polite manner.”
The vote on COVID-19 vaccines emerged from a deeply contentious and polarized debate, during which numerous committee members raised doubts about the safety and efficacy of the shots.
During a debate regarding the vaccine’s protective capabilities, Dr. Natalie Thornburg, head of a respiratory division at the CDC, affirmed that antibodies generated by the vaccines are generally understood to offer protection.
However, fellow panelist Robert Malone countered, asserting that there is no definitive evidence to establish the specific antibody levels required for protection.
“You have no basis to assert your feelings or opinions regarding any correlation between these outcomes,” Dr. Malone declared. “There is no established correlative protection for COVID-19, full stop. Stop claiming otherwise.”
Dr. Fiona Havers, who resigned from the CDC in June following Mr. Kennedy’s dismissal of all 17 previous ACIP members, expressed her dismay at the exchange. Dr. Havers is a frequent presenter at ACIP meetings.
“I was shocked by Robert Malone’s tone towards Dr. Thornburg, a highly respected CDC scientist,” Dr. Havers commented. “Such blatant disregard for expertise and professionalism would never have been permitted in previous ACIP meetings.”
Several external experts also voiced their astonishment.
Dr. Anne Zink, a Yale public health expert and former Chief Medical Officer of Alaska, noted, “It was disheartening to see ongoing personal attacks on scientists during the ACIP meeting, instead of focusing on data and the overarching goal of public health and well-being for Americans.”
During his presentation, Dr. Levi, leader of the COVID-19 work group, asserted that vaccine effectiveness assessments were “based on very low-quality data and analyses” and that vaccine-related injuries were “demonstrably not recognized.”
(It’s worth noting that his presentation slides, typically made available on the agency’s website, were instead provided to reporters by a health department spokesman during his address.)
Conversely, CDC staff and representatives from prominent medical organizations, including the American Medical Association, along with other experts, collectively reaffirmed their belief in the safety and effectiveness of the vaccines.
“Or, if ‘effective’ is too strong a word, let’s just say they work,” commented Dr. Henry Bernstein, another member of the COVID-19 work group.
The rapid development of COVID-19 vaccines, primarily through Operation Warp Speed, was hailed as a major achievement of the initial Trump administration, leading some to suggest former President Trump for a Nobel Peace Prize.
While Mr. Kennedy recently conceded 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 produced. For years, he has asserted that children receive an excessive number of vaccinations and has erroneously claimed 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. Contradictorily, in a subsequent vote, they maintained that the Vaccines for Children program, which supplies immunizations to approximately half of all American children, should continue to cover the cost of this particular shot.
This contradictory outcome marked a first for the panel, as did their decision to re-vote on the matter on Friday.
Despite being a fundamental responsibility of the committee, some members seemed unaware that approving which vaccines are covered by federal programs is a primary function of their role.
On Thursday, multiple members admitted they were unclear about the subject of their votes, with one explicitly abstaining due to confusion.
The panelists themselves appeared uncomfortably conscious of their public image and the implications of their disarray.
On Friday, Dr. Kulldorff acknowledged the panelists possess “enormous depth and knowledge” regarding vaccines but are “rookies” concerning the established decision-making processes of the committee.
Several medical organizations strongly criticized the committee for deviating from the standard ACIP procedures, which usually involve thorough discussions on feasibility, acceptability, cost-benefit analysis, and equity considerations.
Instead, panelists appeared to be “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 from the Society for Adolescent Health and Medicine.
She emphasized that while all vaccines and medications carry inherent risks, the committee’s true scientific mandate is to objectively 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 vote on that particular vaccine.
“Tabling the vote is both appropriate and a relief,” stated Dr. Noele P. Nelson, a senior author of the current vaccine guidelines and former leader of the CDC’s hepatitis vaccines work group.
She added, “This discussion demands unhurried consideration and would greatly benefit from a more thorough assessment of its public health implications.”
Currently, babies are routinely immunized against hepatitis B within 24 hours of birth. The committee was poised to vote on a proposal to recommend the vaccine only for newborns whose mothers are confirmed infected, suggesting that other infants should not receive the immunization until at least one month of age.
Experts in hepatitis B highlighted the vaccine’s success in virtually eradicating maternal transmission of the disease in the U.S., reducing annual cases from approximately 20,000 before 1991 to fewer than 20 today.
“A universal birth dose recommendation is the sole method to guarantee that no newborns exposed to this virus, including those whose mothers were not screened during pregnancy, are missed for vaccination,” emphasized Dr. John W. Ward, Director of the Coalition for Global Hepatitis Elimination and former head of the CDC’s viral hepatitis division.