After a tension-packed two days that saw changes to the MMRV vaccine schedule and COVID-19 recommendations, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and “understanding” of their role.
At the end of a long meeting of the CDC’s revamped vaccine advisory committee, committee member and COVID-19 vaccine workgroup leader Retsef Levi announced a series of four votes that had not been published ahead of time.
Of particular interest was a vote on a recommendation that all COVID-19 vaccines require a doctor’s prescription—a non-binding recommendation. The Advisory Committee on Immunization Practices (ACIP) also voted that all patients receive a consultation with a healthcare provider about the rare adverse effects of COVID-19 vaccines. A third vote revamped ACIP’s recommendation to the CDC on the nation’s COVID-19 schedule, suggesting that anyone over age 65 get the vaccine, or anyone aged six months to 64 if they have an underlying condition, while the fourth recommended adjustments to COVID-19 vaccine information sheets to include more information about adverse events.
Although the votes were not known even to most of the committee members ahead of time (“I’ve hardly had a chance to read it,” committee member Cody Meissner said of one of the proposals), three of the four passed—only the vote to recommend requiring a prescription for vaccines was unsuccessful, with committee chair Martin Kulldorff breaking a dramatic 6-6 vote.
“This a tie, and the chair breaks it,” Kulldorff said. “I vote no, so motion has failed.”
A Lack of Knowledge
On Thursday, the opening day of the meeting, the ACIP debated at length the risks of adverse events like febrile seizures in children receiving the measles, mumps, rubella and varicella vaccine. The meeting’s second day brought even more questions and tensions regarding the country’s vaccine policies.
To start Friday’s marathon session, Kulldorff addressed the confusion that reigned the previous day, when the committee voted to recommend against a combined measles, mumps, rubella and varicella (chickenpox), or MMRV, vaccine for children under the age of four, instead advocating for separate measles, mumps and rubella (MMR) and varicella (V) shots to reduce the risk of rare febrile seizures, which occur in about eight of every 10,000 vaccinations.
At the same time, the committee voted to continue recommending the combo MMRV shot for children receiving vaccines through the Vaccines for Children (VFC) program, which immunizes around 52% of kids in the U.S.
Observers noted that the committee seemed to misunderstand what they had been voting for, based on the conflicting conclusions.
“It reveals such a lack of understanding on the part of the committee on the role of what the ACIP is and the implications of their decisions,” Jason Schwartz, associate professor of public health at the Yale School of Public Health, told BioSpace. “There’s a clear lack of knowledge that committee members typically have; it just isn’t there.”
Dorit Reiss, professor of law at UC Law San Francisco, agreed. “I think we’re seeing what happens when you appoint someone without previous experience,” she told BioSpace, “and do not give [the committee] the benefit of at least some people who know what they’re doing.”
At one point on the first day of the meeting, ACIP member Robert Malone asked if MMR and MMRV shots had the same amount of adjuvant within them, which they do not. That question revealed a lack of background on Malone’s part, Reiss noted.
“I was surprised and dismayed by how uninformed Dr. Malone was,” Reiss said, adding that Malone showed a “deep lack of knowledge” when he asked this question. “If he doesn’t know that, he really doesn’t know what he’s doing on vaccines, and he was one of those people I was expecting to have some knowledge.”
The committee voted Friday morning to reverse its recommendation for children covered under the VFC and align it with its other recommendation, so that all children in the U.S. are recommended to get separate MMR and V shots before the age of four. ACIP votes are non-binding recommendations to the CDC, though they do affect health insurance coverage in some states.
Delayed Decisions
Next up on the agenda was a much-anticipated vote to change recommendations for the “birth dose” of the hepatitis B vaccine for newborn babies, generally within 12 hours of birth. However, the committee ended up postponing that vote until further study could be conducted. The CDC reports that the vaccine is safe and effective, providing protection to 98% of healthy term infants.
That decision came after prolonged data presentations from career CDC scientists earlier in the morning. These talks emphasized the safety and efficacy of the hepatitis B vaccine, as ACIP members peppered the presenters with questions about their vaccine data in what Schwartz described as an adversarial tone.
“ACIP and CDC had a long and deep, productive relationship that is now gone,” Schwartz said.
The tenor of the discussion came to the notice of even the ACIP members themselves. At one point on Thursday, the committee debated whether “irritability” post-vaccination was an adverse effect
Meissner told his fellow committee members that “irritability and restlessness are not objective measures to consider” in vaccines.
Amy Middleman, a subject matter expert representing the Society for Adolescent Health, spoke up to remind ACIP members that “there’s a risk to crossing the street,” and that they shouldn’t get distracted by individual studies that showed rare adverse events associated with a particular vaccine.
Representatives of scientific and medical societies spoke during the comment section to advocate for the hepatitis B vaccine, COVID-19 vaccines and mRNA vaccines in general. They also asked for the chair to post the exact recommendations that the committee is voting on, which at the time was still not published online and had not been revealed in the meeting. Speakers came from societies like the Infectious Disease Society of America and the Pediatric Infectious Diseases Society, as well as private individuals calling in.
After the final vote, Kulldorff brought the vote to a close, thanking all involved for the “spirited discussions.”
