In the second and final day of the Centers for Disease Control and Prevention's (CDC’s) Advisory Committee on Immunization Practices (ACIP) September meeting, members of the panel scrapped one vote, reversed another and, in one of four votes on COVID-19 vaccines, stopped just short of an endorsement that had the potential to significantly impede access for many people living in the U.S.
Asked whether state and local jurisdictions should require a prescription for individuals to receive a COVID-19 vaccine, the panel was split down the middle, with six “yes” votes and six “nos.” But, because the advisory committee’s chair, Martin Kulldorff, Ph.D., was among those who voted against it, the recommendation did not pass.
The outcome followed tense debate over whether the recommended prescription requirement would hinder the availability of COVID shots for Americans, with rifts emerging both between the medical liaison organizations sitting in on the meeting and between the ACIP members themselves.
The panel also voted on and passed three other recommendations. The entire committee voted "yes" on a proposal to urge the CDC to adjust pediatric and adult COVID-19 vaccine schedules to emphasize “individual-based decision-making,” also known as shared clinical decision-making. In practice, that means discussing the matter with a doctor or other healthcare provider before a vaccination.
Under the recommendation, the panel urged that doctor-patient conversations around COVID vaccines for people between the ages of 6 months and 64 years emphasize that the risk-benefit profile is “most favorable for individuals who are at increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk.” That language aligns with the restricted FDA approvals granted to Pfizer and Moderna’s updated COVID-19 vaccines last month.
The other two votes revolved around encouraging the CDC to provide public communications on certain COVID-19 vaccine “risks and uncertainties” included in an ACIP work group presentation (PDF) and a recommendation that authorized healthcare providers should discuss the risks of vaccination with individual patients.
The first issue passed with 11 "yes" votes and a single "no,” while the second was backed unanimously by all 12 ACIP members.
The vote on a prescription requirement for COVID vaccines undoubtedly posed the greatest threat of disruption to current U.S. vaccine policy, though the ACIP members butted heads over exactly what the access implications of their decision would be.
“We’re not currently authorized as providers in [Medicare] Part B language, and so we can’t currently write a prescription,” ACIP panelist Hillary Blackburn, director of medication access and affordability at specialty pharmacy Ascension Rx, said ahead of the vote. “In some states … it would be a barrier for access if a prescription is required.”
Blackburn brought up the issue in an effort to amend the language in the voting question, but, as several of her ACIP peers suggested she may simply want to vote “no” on the recommendation, the issue was moved to a debate. The move marked a continuing theme of uncertainty among the panelists—both Thursday and Friday—about the weight their votes carried and the consequences of the voting question language.
Catherine Stein, Ph.D., a professor in the department of population and quantitative health at Case Western Reserve University—who was added to the committee just this week—echoed Blackburn’s concerns.
“I am all about informed consent, and I think given the earlier discussions about risks and benefits … that discussion is really important,” she said. “But I’m really concerned about the requirement of a prescription, because I believe the segment of the population that is underinsured has lack of access to healthcare—they’re going to be unable to get a prescription, and those are the people that are at highest risk for a lot of these comorbid conditions.”
Aside from safety data presented by the CDC at the ACIP’s request, panel member Retsef Levi, Ph.D.—a professor of operations management at the MIT Sloan School of Management—offered a separate work group presentation outlining efficacy concerns as well as apprehensions around safety signals such as myocarditis.
Other panelists, like pediatrics professor and former pediatrician Cody Meissner, M.D., and Joseph Hibbeln, M.D., former chief of the section on nutritional neurosciences at the National Institutes of Health, also expressed significant misgivings about impeding access with a COVID shot prescription requirement.
But Levi dissented, arguing that he believed the vote was about “leaving this to every state to figure it out, and the state can decide if it’s going to indeed limit access.”
He then pressed harder on the question of access: “So we are saying that people that don’t have access to medical—so how would they get antibiotics? Why? Based on that logic, we would need to also allow taking over-the-counter antibiotics and other prescription drugs. Why would we do that? We don’t do that because we believe that the prescription of these interventions requires some nuanced assessment of the medical condition of the person to actually decide whether it’s appropriate or help them decide whether it’s appropriate for them to take.”
But Meissner came back swiftly against that line of thinking, noting that he was “a little uncomfortable” with the comparison between antibiotics and vaccines, since one is given to a sick person and the other is generally intended to help protect healthy people.
“If we require a prescription, you know we’re going to increase healthcare costs,” he added. “And I don’t think this is a reasonable basis to do that.”
Aside from the discussion on COVID-19 vaccines, the ACIP members on Friday moved to punt a planned vote on universal hepatitis B virus (HBV) vaccination at birth out to a future date. After concluding discussion on the matter Thursday, ACIP members started to revive talks on the HBV universal birth vaccine—with one member attempting to bring in new data she’d reviewed the previous evening. Deliberations quickly broke down, with the panelists ultimately voting to table the decision.
Separately, the ACIP members reversed their vote on a recommendation they’d shot down Thursday pertaining to coverage of Merck’s combination measles, mumps, rubella and varicella (MMRV) vaccine under the U.S.’s Vaccines For Kids (VFC) coverage program.
The original vote to maintain VFC coverage on Thursday conflicted with the panelists’ decision to urge against recommending the MMRV shot as the first dose in a two-vaccine MMRV immunization sequence.
Kulldorff gave his take on the situation at the top of Friday’s meeting, noting, “There is one thing, though, in which we are rookies, and with one exception, this was either our first ACIP meeting or second, and there are many technical issues that we might not grasp as of yet.”
The “exception” Kulldorff referred to was Meissner, who is the only current ACIP member to have served on the committee previously.
Back in June, Department of Health and Human Services Secretary Robert F. Kennedy Jr. ousted the entire sitting ACIP committee, citing issues with conflicts of interest, before quickly slotting in his own appointees.
As the meeting wrapped up Friday, confidence in the ACIP among the broader medical community looked to be on incredibly shaky ground.
Friday, 75 health organizations—including the American Association of Nurse Practitioners, the American Pharmacists Association, the American Public Health Association, the National Association of Pediatric Nurse Practitioners and many others—sent a letter (PDF) to the ACIP calling on the vaccine panel to truly uphold gold-standard science, vote to recommend full vaccine schedules that ensure access and patient choice, and recommend COVID-19 vaccines for all people in the U.S. ages 6 months and older.
Many of those medical associations previously participated in ACIP work groups that helped the panel draft its voting questions. However, they were iced out of the process in early August.
Representatives from those liaison groups were allowed to speak during Friday’s meeting, but their time was limited, and it seemed apparent they didn’t feel their voices were being heard.
"You want debate and discussion, but you're muting people and silencing them," the American College of Physicians’ Jonathan Goldman, M.D., said at one point after repeated attempts to mute his mic.
Meanwhile, the American Medical Association noted in a Friday statement that the ACIP's new processes and recommendations "leave parents confused about how best to protect their kids and unable to choose the combined MMRV vaccine for children under 4 years old."
The organization continued that it's "concerned that this change not only reduces parental choice, but also reflects ACIP’s reliance on selective data in forming its guidance."