Kennedy’s Vaccine Panel Stops Short of Major Changes to U.S. Policy

The vaccine committee was supposed to focus on Covid-19 shots. Instead, confusion reigned. (Joe Raedle/Getty Images)

Key Points

About This Summary

• A vaccine committee delayed voting on Health Secretary Kennedy’s proposal to change hepatitis B vaccination guidance.
• The proposed change would have allowed parents to delay the shot until a month old, going against CDC’s recommendation.
• Kennedy replaced committee members in June with critics of federal Covid-19 policies, causing confusion within the group.

Health secretary Robert F. Kennedy’s handpicked vaccine committee stopped short of making major changes to U.S. policy on Friday, issuing a recommendation that appeared to preserve insurance coverage for the updated Covid-19 vaccines.

Early in the day, the committee postponed a vote that would have significantly changed its recommendations for hepatitis B vaccines for newborns.

While the committee didn’t take the dramatic action on vaccine recommendations that medical experts had widely anticipated it might, it came close. The committee narrowly rejected a proposal that would have recommended that patients be required to get a prescription to receive a Covid-19 vaccine.

Most states allow patients to get Covid-19 shots without a prescription. While the committee doesn’t have the power to change state laws or policies, the recommendation could have created deep complications for patients trying to access the shots.

The vote on the prescription requirement was tied, with six committee members in favor and six opposed. The chair, Martin Kulldorff, opposed the recommendation, and broke the tie to reject the proposal.

In the most consequential vote of the day, the Advisory Committee on Immunization Practices, which issues guidance on how doctors and patients should use vaccines in the U.S., softened its recommendations for who should receive Covid-19 shots, but did so in a way that seems intended to preserve insurance coverage for virtually anyone who wants to be vaccinated.

Last year, the Centers for Disease Control and Prevention had said that all persons aged six months and up should get an updated Covid-19 vaccine. Now, the committee is recommending that people aged 65 and up should make an individual decision in consultation with their doctor about getting a Covid-19 shot.

The committee is also recommending that people aged six months to 65 years should make an individual decision about getting a Covid-19 shot in consultation with their doctor, “with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at increased risk for severe Covid-19 disease.”

The FDA approved this year’s updated Covid-19 shots for all patients aged 65 and up, and for high-risk patients aged six months to 64 years.

The framing of the new recommendations appears to continue to require insurers to pay for the shots for those who want them. “This means that there is no insurance restrictions on getting this vaccine,” Kulldorf said during the committee’s debate.

The failed proposal to urge states to require prescriptions for Covid-19 shots was a matter of heated debate on the panel. “It’s essentially going to be a barrier for people to have access to this vaccine,” said Dr. Cody Meissner, one of the committee members.

Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology who sits on the committee and who led the subcommittee that drafted the Covid-19 vaccine proposals, said it wouldn’t restrict access. **“**We are making an aspiration statement here,” he said.

The committee also voted 11 to 1 in favor of a resolution calling on the Centers for Disease Control and Prevention to add additional warnings about the Covid-19 to factsheets the CDC distributes known as Vaccine Information Statements. There was some confusion among committee members as to the resolution’s meaning.

Moderna shares were down 1.2% on Friday afternoon, while Pfizer shares were down 0.4%.

The committee didn’t share the proposed language of the new guidance until shortly before the vote. In the past, the committee has posted proposed guidance days before voting.

The votes came after a long day of presentations on the Covid-19 vaccines, some from CDC staff and some from outside speakers. The discussions covered a range of potential concerns about the safety of the Covid-19 shots.

Levi raised sweeping questions about how the safety and efficacy of the vaccines are studied.

“I want all of us to ask, do we have a culture of safety?” Levi said.

“I think there is strong evidence that the committee is biased and lacks the expertise to assess the data,” said Dorit Reiss, a professor of law at UC Law San Francisco, who specializes in vaccine law and policy. “Most of these members were chosen for their hostility to COVID-19 vaccines.”

The debate over the Covid-19 shots came on the second day of a two-day meeting. Friday’s meeting began with a setback for Kennedy’s effort to rework government recommendations for how children should be vaccinated, when the committee chose not to vote on a significant proposed change to federal guidance on the hepatitis B vaccination.

The committee skipped the hepatitis B vote because of confusion over the proposed resolution’s language, and disagreement among some members.

Kennedy is a longtime critic of the childhood vaccine schedule put out by the Centers for Disease Control and Prevention. Earlier this week, the former CDC director Dr. Susan Monarez, whom Kennedy fired late last month, told a Senate committee that Kennedy had told her that CDC’s childhood vaccine guidance “would be changing in September,” and that he “spoke to the president every day about changing the childhood vaccine schedule.”

The committee voted on Thursday for a tweak to CDC recommendations for how children are vaccinated against chickenpox. Under the new guidance, children younger than four are recommended to receive a stand-alone chickenpox shot and a combination measles, mumps, and rubella shot, rather than a combination shot that protects against all four viruses.

The change in chickenpox guidance doesn’t carry major consequences. The new guidance appears similar to prior CDC guidance, and few toddlers currently receive the four-disease combination shot that the committee’s new guidance opposes.

The change to the hepatitis B recommendation would be far more significant. The proposed change would have recommended that babies born to mothers who test negative for hepatitis B not be vaccinated against the virus until they are at least a month old. Since 1991, the CDC has recommended all babies receive a hepatitis B vaccination at birth.

In a presentation on Thursday, a CDC official, Dr. Adam Langer, said dropping the recommendation for all infants to be vaccinated immediately at birth against hepatitis B could increase the number of cases of babies who contract hepatitis B during birth.

Dr. Paul Offit, a vaccines expert and director of the Vaccines Education Center at the Children’s Hospital of Philadelphia, told Barron’s on Thursday that mothers who test negative may still carry the virus.

“It adds an additional level of risk without any benefit,” Offit said of the proposed delay. “The vaccine is safe.”

The proposed change to the hepatitis B shot guidance had included language that would have allowed parents to choose to vaccinate their children against hepatitis B at birth in consultation with their doctors.

During the discussion early Friday on the delayed vote, it appeared that some committee members wanted to remove that language, and supported the delay to redraft the recommendation without such an allowance.

At least one member, Dr. Meissner, who has served an earlier term on the same committee and was Kennedy’s most traditional appointment, appeared to oppose a change to the hepatitis B guidance.

“It’s very, very difficult to prove the absence of harm,” Meissner said. “It’s simply not a practical objective. And I think the experience we have accrued of administration of a dose of the vaccine in the first 12 to 24 hours is overwhelming.”

In June, Kennedy fired all of the committee’s members, and has replaced them with a handpicked group, many of whom were notable critics of the federal government’s Covid-19 policies during the pandemic.

The committee’s decisions guide which shots insurers are required to cover without copays, though an insurance industry group said this week that insurers would continue to pay for all shots that the committee had recommended as of Sept. 1.

Friday’s meeting, which was meant to focus entirely on new recommendations for this year’s Covid-19 shots, opened with signs of confusion within the committee’s new leadership. The committee’s chair, Martin Kulldorff, asked the group to reconsider a vote they had taken late Thursday that applied the new chickenpox shot guidance to a federal program that pays for vaccines for low-income children.

The votes taken on Thursday would have tweaked the CDC’s overall guidance for chickenpox vaccination, but would have kept the old guidance for children benefiting from the low-income program, called the Vaccines for Children Program.

On Friday, the committee reversed its vote on the Vaccines for Children Program, aligning the recommendations for the program with its broader recommendations for all children.

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