The vaccine safety panel for the Centers for Disease Control and Prevention voted to drop federal guidance that all children be vaccinated against hepatitis B at birth, breaking with more than three decades of precedent and providing a significant win to vaccine skeptics.
The Advisory Committee on Immunization Practices, which advises the CDC on vaccine safety decisions, voted on Friday to change the recommendation for infants born to mothers who test negative for hepatitis B. Instead of vaccinating all children within the first 24 hours of life, the committee recommended that infants born to mothers with a confirmed negative test do not need to be vaccinated until two months of age.
The birth dose of the hepatitis B vaccine has been in the political spotlight in recent months as Health and Human Services Secretary Robert F. Kennedy Jr., a longtime skeptic of vaccines, has called into question the safety of the childhood vaccine schedule and raised the idea that there is a link between vaccines and autism.
Kennedy fired the original members of the ACIP, an independent advisory body, in June and replaced them with people who were more skeptical of vaccines and mandates, particularly for COVID-19 vaccines.
Friday’s decision is a major boost for those who are skeptical of infant vaccines and is the largest upset in vaccine precedent since the new members were appointed by Kennedy. It is strongly opposed by professional medical associations.
The panel voted 8-3 to recommend that hepatitis B confirmed-negative mothers use “individual-based decision-making, in consultation with a healthcare provider” in deciding “when or if” to vaccinate their children against hepatitis B.
Hepatitis B, a serious liver infection, can lead to chronic liver problems for infected infants and children. Nine in 10 infants born to mothers who are hepatitis B-positive are likely to develop chronic hepatitis B, and approximately a quarter of those patients will die from liver disease or liver cancer.
The universal birth dose recommendation was set by the CDC in 1991 in part because more targeted interventions toward population groups most at risk, namely intravenous drug users, homosexual men, and certain immigrant groups, were unsuccessful in lowering infection rates.
The hepatitis B vaccine, particularly the infant dose, has been in the political spotlight in recent months as part of the Make America Healthy Again movement’s focus on the childhood vaccine schedule.
The ACIP members discussed at length over the Thursday and Friday meeting days the lack of clear information on the risk of infection for infants and children born to hepatitis B-negative mothers due to community exposure to the virus.
Retsev Levi, a Massachusetts Institute of Technology professor of operations management and healthcare analytics, said during the meeting that parents should be “very, very suspicious” of advisers who say that vaccines are safe for infants, particularly the birth dose of the hepatitis B vaccine.
“Mind you that we are talking about a very, very young baby in the first few months of their life, where they are not fully developed, and where we don’t know the exact potential impact of exposure to vaccines, but we do know that their immune system is not fully developed, their metabolism is not fully developed, their brain is not fully developed,” Levi said.
Dr. Evelyn Griffin, the only practicing OB-GYN on the committee, said several times during the two-day conference that a universal hepatitis B vaccine is tantamount to a “safety net” not only for herd immunity but also for gaps in the healthcare system where mothers are not tested before birth or do not receive appropriate prenatal care.
“I do have a problem with treating our babies as a safety net,” Griffin said. “I obviously do not want any babies to be missed and to have infection. But there was a discussion of safety net built in a completely different context.”
ACIP member Hillary Blackburn, a doctor of pharmacy, said the recommendations are particularly to protect parents from being discriminated against or pushed out of pediatric practices for choosing to delay vaccination.
“No child should lose their medical home because their parents are engaging in the very individualized-based decision making that we’re encouraging,” Blackburn said.
ACIP member Catherine Stein said during Friday’s deliberations that the change in language does not affect recommendations for infants to be vaccinated against hepatitis B.
“This voting language does not change the recommendations for the children born to mothers that are hepatitis B confirmed positive and also for those that are unknown status,” Stein said. “And again, the unknown status addresses the gaps in care that we discussed extensively.”
ACIP panel recommendations are not binding until the acting CDC director adopts them, but many states and insurance companies tie their coverage of vaccines directly to ACIP recommendations regardless of CDC adoption.
The Center for Medicare and Medicaid Services, which governs rules for both public and private insurance coverage, provided reassurance that the language of the vote will not affect insurance coverage for the hepatitis B vaccine given at any point in infancy, addressing concerns that the change in recommendations will make it harder for some people to access the vaccines.
But two members of the committee said multiple times during the debate that there is little evidence to suggest it is safer to administer the vaccine at two months of age rather than at birth.
Dr. Cody Meissner, a professor of pediatrics at Dartmouth College, and Dr. Joseph Hibbeln, a former neuroscientist for the National Institutes of Health, were the loudest critics of changing the birth dose recommendation.
“I guess people are opposed to the neonatal birth dose because they think there’s harm that outweighs benefit. Well, why does that change at two months?” said Meissner, adding that he sees “plenty of evidence of a likelihood of lack of protection in an increased number of infants if the vaccine series is started at two months of age.”
The universal birth dose for the vaccine has faced opposition since it was recommended by the CDC 30 years ago, in large part because hepatitis B was closely associated with the HIV-AIDS epidemic of the 1980s.
GOP doctors, including Sens. Rand Paul (R-KY) and Bill Cassidy (R-LA), have debated whether babies need to be vaccinated against what critics characterize as primarily a sexually transmitted infection.
Paul, who is generally very supportive of all the MAHA movement, has supported parents who choose not to get the birth dose, whereas Cassidy, a specialist in liver disease, has been a staunch advocate of the birth dose.
President Donald Trump weighed in on the controversy following discussions on the hepatitis B vaccine during ACIP’s September meeting, saying he believes there is “no reason to give a baby” the vaccine and recommended that parents “wait ‘til the baby is 12.”
Sen. Ron Johson (R-WI) praised the ACIP’s decision, saying on X after the vote that “science triumphs over insanity.”
Cassidy, by contrast, posted on X shortly after the announcement of the vote that the change “is a mistake” and advised that acting CDC Director Jim O’Neill reject the committee’s recommendations.
“Before the birth dose was recommended, 20,000 newborns a year were infected with hepatitis B,” Cassidy wrote. “Now, it’s fewer than 20. Ending the recommendation for newborns makes it more likely the number of cases will begin to increase again. This makes America sicker.”
The American Medical Association also condemned the decision, saying it “undermines decades of public confidence in a proven, lifesaving vaccine.”
“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,” Dr. Sandra Adamson Fryhofer, an AMA trustee, said in a statement.
Meissner said during the voting process that the committee is “doing harm by changing this wording.”
CDC TO RECOMMEND PARENT CHOICE FOR HEPATITIS B VACCINES FOR NEWBORNS
Meissner and Hibbeln voted against the change, as did transplant immunobiologist Raymond Pollak.
“This has a great potential to cause harm, and I simply hope that the committee will accept its responsibility when this harm is caused,” Hibbeln said.
