CDC Committee Votes to Delay Hep B Vaccine for Most Newborns

The CDC’s Advisory Committee on Immunization Practices passed a significant change to newborn vaccine guidance on Friday. (Ben Hendren/Bloomberg)

A powerful federal public-health advisory committee voted early Friday to reverse decades-old guidance from the Centers for Disease Control and Prevention that recommended a hepatitis B vaccine for all infants at birth.

A new recommendation passed by the committee will tell parents of most infants to consult with doctors about whether their babies should be inoculated at birth. Infants not vaccinated at birth are suggested to receive their first dose “no earlier than 2 months of age,” the referendum says.

Babies born to mothers who have hepatitis B, or whose hepatitis B status is unknown, would still be recommended to be vaccinated at birth under the new guidelines.

The vote passed with eight votes in favor and four against.

The measure has been widely criticized by public-health experts in the U.S. They say that the universal recommendation for hepatitis B shots protects infants whose mothers have an undiagnosed hepatitis B infection, or who are exposed to hepatitis B in the first weeks of their lives.

“We are doing harm by changing this wording,” Dr. Cody Meissner, a former chief of division of pediatric infectious diseases at the Tufts Medical Center, said as he cast his vote against the measure.

The committee also voted to recommend that parents talk to doctors about testing the blood of infants who have received a birth dose of hepatitis B vaccine, to see if an additional dose is needed. That new recommendation implies that a single dose may be sufficient if babies have a certain level of anti-hepatitis B antibodies in their blood. The hepatitis B vaccine is generally given as a three dose series.

The second vote passed with six votes in favor, four against, and one abstention.

The guidance likely won’t impact insurer coverage of the shots, since most insurers are still required to cover vaccines that get a “shared clinical decision-making designation” from ACIP.

Meissner said during the meeting that the second resolution was “kind of making things up.” He said it was unknown whether high antibody levels after a single dose of the vaccine meant that an infant would have long-term protection against hepatitis B. “That’s been kind of pulled out of the air,” he said.

Hepatitis B infections can lead to liver cancer, liver failure, and death over the long term. Since the CDC introduced its universal hepatitis B vaccine recommendation for all newborns in 1991, the incidence of pediatric hepatitis B virus has dropped by 99%. The committee’s new recommendations must be adopted by the CDC’s acting director before they become official agency guidance.

The votes, which were postponed from an earlier meeting of the Advisory Committee on Immunization Practices in September, and was initially meant to be held on Thursday, represents health secretary Robert F. Kennedy Jr.’s most significant change thus far to how vaccines are used in the U.S. The committee’s recommendations must be adopted by the acting director of the CDC.

Kennedy, who co-founded the nation’s leading anti-vaccine advocacy group, replaced all the members of the ACIP early this year. One committee member, Retsef Levi, a professor of operations management at the MIT Sloan School of Management, said early during the Friday meeting that parents should be generally skeptical of all vaccines.

“I suggest to parents to be very, very suspicious when people tell them that something is safe, especially a vaccine,” Levi said. “Because we have been adopting a very, very confident way of telling parents about vaccine products, that they are completely safe, where we essentially never tested them appropriately.”

A review published ahead of the meeting by the Vaccine Integrity Protect, a project of the Center for Infectious Disease Research and Policy at the University of Minnesota, said that results of randomized trials, safety monitoring programs, and follow-up studies had found that the hepatitis B vaccine is safe.

Two members of the committee, Meissner and Dr. Joseph Hibbeln, a former chief of section on nutritional neurosciences at the National Institutes of Health, were harshly critical of the resolutions ahead of the vote on Friday.

“The vaccine is so effective, it does not make sense in my mind to change the immunization schedule,” Meissner said.

During a discussion of the second vote, a CDC expert, Dr. Adam Langer, said it would be a “really huge assumption” to believe that a single dose could offer lasting protection against hepatitis B, even if blood tests showed a certain level of antibodies. “There really is no reason not to give the full series,” Langer said. “There is no evidence of any significant, long-term adverse event.”

Hibbeln, for his part, said that no evidence had been presented to the committee to back up that suggestion that infants who do not get a birth dose of hepatitis B vaccine wait two months for their first shot. He called the language of the recommendation “unconscionable.”

The meeting is scheduled to continue through the afternoon with discussions of the childhood and adult immunization schedule, though no further votes are planned.

Scheduled presenters include Dr. Tracy Beth Høeg, who was appointed early this week as acting director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Aaron Siri, a Kennedy ally and a vaccine injury lawyer.

Multiple medical groups quickly decried the outcome of the vote. “Today’s action is not based on scientific evidence, disregards data supporting the effectiveness of the Hepatitis B vaccine, and creates confusion for parents about how best to protect their newborns,” the American Medical Association said in a statement on Friday.

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