CDC Advisors Again Postpone Vote on Hepatitis B Vaccine for Newborns

Key Points

• The CDC’s Advisory Committee on Immunization Practices deferred a decision on new hepatitis B vaccine guidelines due to unclear language.
• The proposed guidance would alter the universal recommendation for hepatitis B vaccination at birth, making it optional for some newborns.
• This meeting is seen as a significant step in Health and Human Services Secretary Robert F. Kennedy Jr.’s efforts to rework vaccine policy.

In 1991, the Centers for Disease Control and Prevention told Americans that all newborns should be vaccinated against hepatitis B, a viral infection that can eventually lead to cancer or liver failure. Rates of acute hepatitis B dropped sharply in the U.S. over the decades that followed, and the incidence of pediatric hepatitis B has now fallen by 99%.

On Thursday, the CDC’s outside vaccine advisors met to take their second crack at futzing with the CDC’s hepatitis B vaccine recommendations.

By midafternoon, their effort had stalled, amid confusion on the panel. Complaining that the language of the new proposed guidance was unclear, and had been changed multiple times in the days leading up to the meeting, the committee members voted unanimously to defer their decision until Friday.

If the members do vote Friday to change the hepatitis B vaccine guidelines, it would be the most concrete and serious step yet that the Trump administration has taken to further Health and Human Services Secretary Robert F. Kennedy Jr.’s campaign to rework the vaccine status quo in the U.S.

The meeting comes as the pace of health agency actions on vaccines appears to be accelerating once again.

President Donald Trump’s decision to name Kennedy—who founded the nation’s leading anti-vaccine advocacy organization—as the country’s top health official, led to widespread worries that the administration planned to limit vaccine access severely.

So far, Kennedy’s efforts as health secretary have had no major impact on which vaccines Americans receive regularly. That could change after Thursday’s meeting.

Secretary of Health and Human Services Robert F. Kennedy Jr. Photo: Kevin Dietsch/Getty Images

Kennedy cleared the ranks of the CDC vaccine advisory committee in June, dismissing all its members and replacing them with a handpicked group stacked with committed vaccine skeptics. A September meeting of the committee ended without any major changes to vaccine policy.

There are signs, however, that the Trump administration’s health leaders are turning their attention back to Kennedy’s vaccine priorities. Late last month, a top Food and Drug Administration official, Dr. Vinay Prasad, sent an email to employees of the FDA division responsible for regulating vaccines that promised sweeping changes that would tighten the agency’s approach to vaccine approvals; it also claimed that the agency had linked Covid-19 shots to the deaths of 10 young people.

In his email, Prasad instructed staff who disagree with his “core principles” to resign.

Meanwhile, an FDA spokesperson confirmed Tuesday that the newly-named director of the FDA division responsible for drug approvals, Dr. Richard Pazdur, had decided to retire. Pazdur, a longtime agency leader whose appointment last month was taken as a sign that pre-Trump normalcy was returning to the FDA, spent about two weeks in his role.

It all seems to indicate that leaders at health agencies are prioritizing Kennedy’s ideological aims. The leaked Prasad email, Raymond James healthcare policy analyst Chris Meekins wrote Monday, “highlights a shift of FDA leadership toward close alignment with the vaccine skepticism of the MAHA movement.”

The two-day meeting of the CDC committee, called the Advisory Committee on Immunization Practices, gives Kennedy the best shot yet at making a material change to how vaccines are used in the U.S.

Public health officials had worried ahead of the September ACIP meeting that ACIP would strictly limit access to the Covid-19 shot and might make other serious changes to the childhood vaccine schedule. But during a chaotic and disorganized two-day meeting, the committee suggested no significant changes to vaccine policy, instead recommending an inconsequential tweak to the chickenpox vaccine, issuing Covid-19 vaccine guidance that appeared designed to preserve insurance coverage for anyone who wants a shot, and putting off a vote on the hepatitis B vaccine.

The committee devoted all day on Thursday to discussing the hepatitis B vaccine. The meeting was led by Dr. Robert Malone, who rose to prominence as a critic of the Covid-19 vaccines. Malone was standing in for Dr. Kirk Milhoan, who was named ACIP’s chair on Monday, and who was not physically present at the meeting. The prior chair, Martin Kulldorff, who oversaw the September meeting during which a proposed vote on changing the hepatitis B guidance was postponed, was removed Monday and given a job at the U.S. Department of Health and Human Services.

Malone read three proposed votes to the committee shortly after noon. “This is the third version that most of the ACIP have received in 72 hours,” said one member, Dr. Joseph Hibbeln. “We’re trying to evaluate a moving target.”

“I acknowledge your point as having merit,” Malone responded, before calling a brief recess.

Later, during a discussion of the proposed language, one committee member, Dr. Cody Meissner, made a motion to postpone the votes on hepatitis B until Friday morning. Meissner’s motion was adopted.

While ACIP has historically posted extensive information ahead of its planned meetings, the committee had said next to nothing about what it plans to discuss on Thursday and Friday as of midday Wednesday.

The proposed guidance under discussion on Thursday would have only recommend a dose of the hepatitis b vaccine at birth for the children of women who have tested positive for hepatitis B. For newborns whose mothers have tested negative for hepatitis B, the proposed guidance said parents “should consult with health care providers” to decide whether their newborns should receive a dose.

Current guidance recommends a shot for all babies at birth. A CDC official, Dr. Adam Langer, told committee members during the September meeting that the sooner hepatitis B vaccines are given after birth, the better the shots are at preventing babies from contracting the virus from infected mothers. “Universal birth dose provides a critical safety net for infants who may have unrecognized exposure to [hepatitis B virus] during pregnancy or early childhood, which can result in catastrophic outcomes,” Langer said.

On the first day of the September meeting, the committee put off the hepatitis B vote due to problems with the wording of the proposed resolution. On the meeting’s second day, after a confused discussion, committee members again decided to postpone the vote.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com