Inside ACIP's latest meeting

In June, HHS Secretary Robert F. Kennedy fired all 17 members of ACIP and replaced them with eight new appointees, although one member later stepped down. Several of the appointed members had previously expressed skepticism about vaccines and their safety.

Last week, Kennedy appointed five additional members to the committee, bringing the total number up to 12. So far, ACIP has had two meetings with its new members, the first with the seven initial members in June and the second with all 12 members last week.

During the second meeting, which took place on Sept. 18 and 19, the committee members discussed and voted on several new vaccine recommendations.

MMRV

On Sept. 18, the committee discussed whether the combined vaccine for MMRV should be recommended to children younger than the age of four. Typically, children can receive the MMRV vaccine starting at 12 months of age.

Before voting on the change, members were presented with data showing a small increase in risk of febrile seizures after MMRV vaccination after the first dose, which is currently recommended at 12 to 15 months of age. In comparison, there is no evidence of an increased risk of febrile seizures with MMRV vaccination in children ages four to six, when the second dose is recommended.

According to MedPage Today, the members were somewhat divided over how significant the risk of febrile seizures was and whether removing the recommendation could negatively impact vaccination rates.

"The disadvantage of giving two doses — or, as was suggested, separating the two doses — is that we know compliance falls," said Cody Meissner, a professor of pediatrics at the Geisel School of Medicine at Dartmouth University and ACIP member. "And the advantage of combination vaccines is that children and adults are more likely to complete the vaccine requirements if it's given as a single dose."

Ultimately, the committee members voted 8-3, with one abstention, to no longer recommend the MMRV vaccine before four years of age.

The members also initially voted 8-1, with three abstentions, against aligning the new recommendation with the Vaccines for Children (VFC) program, leading to some confusion about potential coverage for the vaccine. Later, after clarification, the members revoted, with 9 in favor of aligning the VFC program with the new recommendation. Three members abstained from the vote.

These new recommendations mean that the VFC program will no longer be able to cover the MMRV vaccine until children are four years of age.

Hepatitis B

The committee members were asked to consider whether hepatitis B vaccination should be withheld for at least one month for infants who were born to individuals who had tested negative for hepatitis B infection. However, several members said they did not feel ready to vote, expressing confusion about presented data and the wording of the guidelines they planned to vote on.

"I believe that there's enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature," said ACIP member Robert Malone.

In the end, the committee voted 11-1 to delay the new recommendation indefinitely. During the meeting, several liaison members questioned the need to change the current recommendation since there is no new evidence showing issues with the current policy or potential benefits of delaying the vaccine by a month.

"I have not seen any data that says that there is any benefit to the infant waiting a month. But there are a number of potential harms to the infant waiting a month," said Adam Langer, a CDC representative.

In another unanimous vote, the members said CDC should no longer recommend the COVID-19 vaccine for most adults ages 18 and older. Instead, the members recommended that COVID-19 vaccinations should be based on "individual-based decision making." Although the new recommendations do not prohibit anyone ages six months and older from getting vaccinated, they call for patients to speak with a clinician about the risks and benefits first.

"We think that it's appropriate to bring it to something that is being discussed between a physician or medical provider and a patient," said Retsef Levi, an ACIP member who led the COVID-19 work group.

The committee also discussed a recommendation to require people to have a prescription to receive COVID-19 vaccines. Several committee members, as well as outside liaisons, spoke out against requiring a prescription for the vaccine, saying it could decrease patient access, especially for people who are underinsured or don't have primary care providers.

Commentary

Several medical associations, scientific experts, and clinicians, including those who were in attendance, have raised concerns about the recent changes to ACIP, saying that the new committee members ignored expert input, highlighted questionable or preliminary data, and did not follow the established process for developing new vaccine recommendations.

"It's troubling to see the erosion of the committee's integrity," said Sandra Fryhofer, a physician who spoke on behalf of the American Medical Association. "We're concerned about how vaccine recommendations are being developed by this new panel. Data is being selectively used to justify specific conclusions." 

Sean O'Leary, chair of the American Academy of Pediatrics' committee on infectious diseases, said the meeting included clear efforts to "sow distrust" about vaccines and would have "real-time impacts on American children."

"The problem," O'Leary added, "is what you saw today, and what we saw with the last meeting, is that for most of the current voting ACIP members, they don't seem to care about the actual science."

David Higgins, a pediatrician who teaches at the University of Colorado Anschutz Medical Campus, said reports of ACIP's new recommendations are already contributing to increased vaccine hesitancy among patients and their families. According to Higgins, he recently met two families who were hesitant about their children receiving the routine MMR vaccine — not the MMRV vaccine ACIP discussed — due to reports about vaccine concerns raised at the ACIP meeting.

Although the families eventually decided to vaccinate their children after an "empathetic discussion" about their concerns, "[i]t's disheartening to see firsthand the confusion and concern from families simply because of the actions around this meeting," Higgins said.