In a surprise move on Friday morning, a panel of vaccine advisors to the federal government backed off from a proposed change to the vaccine schedule that would have scrapped the current recommendation that all children receive the hepatitis B shot at birth.
It also reversed a vote it took yesterday on coverage for a shot known as the MMRV — measles, mumps, rubella and chickenpox (or varicella). Yesterday, the panel said the Vaccines for Children program could cover the combined shot if parents want it — Friday they voted that it shouldn't. The MMRV shot is no longer recommended to be given, and it will not be paid for by government insurance.
The Advisory Committee on Immunization Practices, or ACIP, had spent much of Thursday debating the rationale for giving newborns the hepatitis B vaccine at birth — but then the committee pushed off the vote until Friday. Instead, it proceeded with a separate vote that removed the MMRV shot for children under age 4 from the vaccine schedule.
"We are rookies," chair Martin Kulldorff said in opening the second day of the meeting. "With one exception, this was either our first ACIP meeting or our second."
The ACIP panel crafts recommendations on vaccine policy for the Centers for Disease Control and Prevention.
RFK Jr.'s influence
Earlier this year, Health Secretary Robert F. Kennedy Jr. fired the existing panel, installed during the Biden administration, and replaced them with his own handpicked roster, including five members he added this week. Some of those he chose have a history of being critical of vaccines.
Kennedy's moves to reshape vaccine policy in the U.S. hinge in part on ACIP's recommendations. Kennedy has a long-running campaign to question the safety of many vaccines. Since being confirmed he's limited access to the COVID vaccines, ditched millions of dollars in funding for mRNA vaccine research, and fired many career scientists at CDC, including its Senate-confirmed director, Susan Monarez.
Though the ACIP panel backed off changing its recommendation for the birth dose of the hepatitis B vaccine, its actions have led the public to question a shot that has been in use since 1991. It has been a success, Sen. Bill Cassidy, D.-La., noted this week.
"We have decreased from 20,000 kids a year getting hepatitis B to 20 kids a year. That's exponential decline," Cassidy, who is a liver doctor, told reporters on Wednesday.
On Thursday, ACIP chair Kulldorff said the panel is setting up two new working groups: one on vaccines recommended during pregnancy and another on the timing of when shots are given on the vaccine schedule. It indicates that Kennedy's ACIP will continue to question well-established vaccine practices.
Confusion dominates meeting
The two-day ACIP meeting, which is held at CDC headquarters in Atlanta and is expected to continue until late afternoon Friday, has been marked by confusion. As he opened it Friday morning, Kulldorff explained that the members' lack of experience led them to need to redo a vote from the previous day because the wording had been confusing.
The outcome of that re-do was to change the insurance coverage of the MMRV vaccine for low-income children. On Thursday, the panel ended with a split vote: MMRV shots were not recommended, but they would be paid for by the government. Friday's re-do vote made it all align — not recommended, not allowed to be paid for.
Then came hepatitis B. Although some on the committee seemed enthusiastic about pushing the first dose recommendation for hepatitis B later in life, after some discussion, there was a revolt against tackling the issue at all.
"I move to postpone the question indefinitely," Dr. Robert Malone, an ACIP member and close associate of Kennedy, said. "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."
That seemed to take Kulldorff by surprise. The committee voted 11 to 1 to table action on the birth dose of hepatitis B vaccine, with Kulldorff as the lone dissent.
Medical experts participating in the meeting as liaisons representing major medical groups seemed relieved by the decision to table the question.
Many had voiced their opposition to overhauling the recommendations, pointing to data showing the current policy had helped dramatically reduce cases of hepatitis B. The proposed changes also ran counter to hours of data presented by the CDC's own scientists supporting the safety and efficacy of offering the shot right after a baby is born.
"It is very easy to get distracted by one study that says this or one study that does say that," noted Dr. Amy Middleman, representing the Society for Adolescent Health and Medicine. "There's always some risk — there's a risk to walking across the street. The committee's scientific challenge is to determine whether the benefits outweigh the risks." She added that she hoped the panel would use scientific tools like grading evidence to evaluate these questions going forward.
COVID shots up next for scrutiny
The panel's votes still require final approval from the acting CDC Director Jim O'Neill. He was installed by Kennedy after the senate-confirmed director, Susan Monarez, was ousted in part for refusing to commit to adopting ACIP's recommendations before she'd seen evidence, she testified to the Senate earlier this week.
Later on Friday, the panel will vote on recommendations on who should be eligible for the latest COVID-19 vaccines.
Children's Health Defense, the anti-vaccine group, founded by Kennedy before he became health secretary, has long targeted the hepatitis B vaccine recommendation, claiming the risk of illness is small for most babies and the vaccine can be harmful.
Tensions between the committee and the medical establishment have surfaced repeatedly throughout the two-day gathering.
On Thursday, Dr. Jason Goldman, president of the American College of Physicians, urged ACIP not to change the recommendations on the MMRV shot and criticized the broader process, saying they've sidelined subject matter experts and clinicians. He also noted that representatives from medical groups have been removed from ACIP workgroups, though they are still able to comment during the public meetings.
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