Advisers to the Centers for Disease Control and Prevention on Sept. 19 voted to postpone a vote on delaying the first dose of a hepatitis B vaccine, which is currently recommended for newborns within hours of birth.
Advisory Committee on Immunization Practices (ACIP) members in an 11–1 vote tabled a motion that would have advised the CDC to recommend pushing the first dose back to a minimum of 1 month of age.
Some members said they favored tabling the motion because of concerns that the CDC misrepresented the safety of the hepatitis B vaccine.
In a presentation on Thursday, Adam Langer of the CDC said that the Institute of Medicine (IOM), now known as the National Academy of Medicine, found the hepatitis B vaccine was “safe and effective,” citing a 2002 report from the institute.
Vicky Pebsworth, an ACIP member, pushed back against the CDC’s characterization, pointing out on Thursday that in its most recent report, in 2012, the institute said a review of available evidence resulted in being unable to reject—or accept—that the vaccine causes a variety of conditions, including encephalitis, or brain inflammation.
“IOM did not conclude that hepatitis B was safe, as has been said here,” she said.
Dr. Robert Malone, another member, who put forth the tabling motion, said Friday he had reviewed the assertions overnight and sided with Pebsworth.
“To interpret that the absence of data implies safety is, I think, a perversion,” he stated.
Other members indicated they voted to postpone the vote because they felt there was a lack of data supporting moving the birth dose back.
“No vaccine is 100 percent safe and no vaccine is 100 percent effective,” Dr. Cody Meissner, another ACIP member, stated. “What’s important for the provider before administering the vaccine is to think about that particular patient, and does the benefit exceed any possible side effect from the vaccine. And when you apply that to a newborn hepatitis B vaccine, I don’t think there’s any question whatsoever that the benefit far outweighs any adverse side effect.”
The Department of Health and Human Services did not immediately respond to a request for comment.
Most European countries do not recommend hepatitis B vaccination at birth unless the mother has hepatitis B. Some don’t recommend it at all for children.
“So far, the hepatitis B vaccine has been too costly to justify its inclusion in the program due to very low number of cases,” a spokesperson for the Finnish Institute for Health and Welfare, which does not recommend hepatitis B vaccination for most children, told The Epoch Times in an email.
Health Secretary Robert Kennedy, who oversees the CDC, had supported moving the birth dose, Dr. Debra Houry, a former top CDC official, testified earlier in the week. Stuart Burns, a Kennedy adviser, “told me that the secretary had suggested age 4,” she said, adding that a different health official told her that the secretary wanted the birth dose moved.
Hillary Blackburn, another ACIP member, was among those who had questioned how a minimum of 1 month of age had been decided, versus 2 months of age, which is when the first dose is recommended in certain other countries.
Martin Kulldorff, chair of ACIP, said he was involved in discussions with CDC officials on the matter.
“I think it has to do with that the second dose is recommended in the U.S. between one and two months,” Kulldorff said.
Several companies make hepatitis B vaccines available in the United States, including Merck and Sanofi.
“The reconsideration of the newborn hepatitis B vaccination on the established schedule poses a grave risk to health of children and to the public, which could lead to a resurgence of preventable infectious diseases,” a Merck official said during the hearing.
A Sanofi official said that “the hepatitis B birth dose and vaccination early in life remain the most effective option for prevention of hepatitis infections in infants and children.”