A Centers for Disease Control and Prevention advisory panel on Friday rescinded a decade-long recommendation that all newborns receive the first dose of hepatitis B vaccine within 24 hours of birth.
Voting took place after a day and a half of heated debate and confusion this included misinterpreted data and calls from public health experts to support recommendations for a vaccine to protect against the incurable infection.
The group, formally known as the Advisory Committee on Immunization Practices, whose members include Secretary of Health Robert F. Kennedy Jr. fired in June and replaced by a group that largely expressed vaccine skepticism – recommending that women who test negative for hepatitis B decide, after consulting with a health care professional, whether their baby should receive a dose at birth. The group suggested waiting until at least 2 months of age for the first dose if the vaccine is not given at birth.
Three of the eight members voted against the change.
“We are doing harm by changing this language, and I am voting no,” said Dr. Cody Meisner, the only ACIP member who previously served on the committee.
Acting CDC Director Jim O'Neill – a former investment executive with no medical background who previously worked at the Department of Health and Human Services under President George W. Bush – will now decide whether to accept the panel's recommendations.
Senator Bill Cassidy, Republican of Louisiana., a liver doctor who chairs the Senate Health Committee and cast a key vote in confirming Kennedy as health secretary, said the panel's new recommendation was a “mistake.”
“Removing the recommendations for newborns increases the likelihood that cases will begin to rise again. It makes America even worse. Acting CDC Director O'Neill should not sign off on these new recommendations and instead maintain the current evidence-based approach,” Cassidy said in a statement.
President Donald Trump praised the commission's decision in a social media post Friday eveningstating that the vaccine committee “has made a very good decision to discontinue its recommendations for hepatitis B vaccination for infants, the vast majority of whom are not at ANY RISK.”
Trump also said in his message that he had signed presidential memorandum “I am directing the Department of Health and Human Services to 'FAST' a comprehensive assessment of immunization schedules around the world,” referring to the number of vaccines in the U.S. childhood immunization schedule.
In the memo, he said Kennedy and the CDC director should study other countries' best practices regarding vaccine recommendations and the underlying science. “And, if they determine that these best practices are superior to current domestic recommendations, update the core U.S. childhood immunization schedule to be consistent with such scientific evidence and the best practices of peer developed countries, while maintaining access to the vaccines currently available to Americans,” the memo states.
Dr. Susan Kressley, president of the American Academy of Pediatrics, said the change in panel composition makes children in America less safe.
“They are vulnerable when it is our responsibility to protect them as much as possible,” Kressley said. “I encourage parents to talk to their pediatrician and get the hepatitis B vaccine at birth, regardless of the mother’s status.”
The committee “has not provided any information or data to show that this new approach is safer and will be safer for children. In fact, we know as doctors caring for children that it will make them more vulnerable,” she said, adding that there is no evidence that the vaccine poses a risk to newborns.
The panel also voted to require parents to consult with health care providers about testing their children for hepatitis B antibodies before deciding whether their child needs another dose of the vaccine after the first.
The hepatitis B vaccine is usually given to infants as a series of three doses. Typically, after the first dose is given within 24 hours of birth, babies receive a second dose between 1 and 2 months of age and a third dose between 6 and 18 months.
Some panel members expressed concerns about vaccination during the newborn period, a critical period of brain and immune system development, even though hepatitis B vaccine has been safely administered to newborns for decades. Others said they had not seen data to support delaying dosing until two months or older.
“We must make decisions based on the data we have, and we must use only hard data to make decisions, not speculation and hypotheses,” said ACIP member Dr. Joseph Hibbeln, a psychiatrist and neuroscientist.
Ahead of the vote, representatives of the contact groups called on the commission to reconsider changing the current recommendation.
“This vote is an unnecessary decision to find a problem that needs to be solved,” said Dr. Jason Goldman, president of the American College of Physicians, speaking directly to panel members. “This will not address your concerns about informed consent and will only put children at risk.”
Dr. Amy Middleman, a spokeswoman for the Society for Adolescent Health and Medicine, noted that CDC infectious disease experts cannot fact-check misinformation before it is presented to the public.
“As a hepatitis B researcher, I can confirm that there has been a lot of misinformation presented over the last couple of days,” Middleman said.
The commission did not change its current recommendation to vaccinate newborns whose mothers test positive for hepatitis B or whose infection status is unknown. Hepatitis B can be passed from mother to baby during childbirth and can lead to liver disease, cancer and death.
Kennedy, an anti-vaccination activist, has frequently cited the debunked theory that vaccines may be linked to autism. Earlier this year he said conservative commentator Tucker Carlson that the CDC suppressed data showing an increased risk of autism among newborns who received the hepatitis B vaccine.
After Kennedy's shakeup of the vaccine advisory panel in June, many states began ignoring the panel's recommendations and instead relying on recommendations from professional societies or newly formed public health alliances.
Public health experts are concerned that the new guidelines will make hepatitis B vaccination recommendations less clear to doctors and patients because they do not advocate vaccinating newborns.
“The more confusing we make these recommendations, the harder it will be for doctors to implement them,” said Chari Cohen, president of the nonprofit Hepatitis B Foundation.
Cohen also questioned how feasible it would be to test infants for hepatitis B antibodies, which requires a blood draw.
“If we're talking about doing fewer things that could harm our children, why would we give them blood tests? And who would agree to that?” – said Cohen.
Food and Drug Administration Commissioner Marty Macari told NBC News in a sit-down interview Thursday that available data does not support a universal birth dose for hepatitis B.
“When a parent wants to wait until a child is 8, 10 or 12 years old, we need to listen to those parents and be honest with them that there is no scientific evidence that there is a benefit from doing it on the first day of life versus 10 or 12 years old,” he said.
Many doctors and public health experts strongly disagree. Not all pregnant women are tested for hepatitis B, so public health experts say delaying vaccinations could lead to more infections.
Cases of acute hepatitis B among children have dropped sharply since the US Centers for Disease Control and Prevention (CDC) began to recommend a universal birth dose in 1991 fall 99% from 1990 to 2019. Center for Disease Control and Prevention analysis For children born between 1994 and 2023, hepatitis B vaccination is estimated to have prevented more than 6 million infections and nearly 1 million hospitalizations.
On Tuesday Vaccine Integrity Project — a University of Minnesota initiative aimed at advocating the use of vaccines in the United States — published a review of more than 400 studies that found no evidence of short- or long-term health problems due to hepatitis B vaccination after birth. Although the article was not published in a peer-reviewed journal, it was reviewed by major medical societies, including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Infectious Diseases Society of America.
