CDC advisory panel rolls back universal hepatitis B vaccine recommendation

( NBC )

The Centers for Disease Control and Prevention’s vaccine advisory panel on Friday rolled back a decadeslong recommendation that all newborns get a first dose of the hepatitis B vaccine within 24 hours of birth.

The vote came after a day and a half of heated debate and confusion that included misinterpreted data and pleas from public health experts to uphold recommendations for the vaccine that protects against an incurable infection.

The panel, formally known as the Advisory Committee on Immunization Practices — whose members Health Secretary Robert F. Kennedy Jr. fired in June and replaced with a group that has largely expressed skepticism of vaccines — recommended that women who test negative for hepatitis B can decide in consultation with a health care provider whether their baby should get the birth dose. The group suggested waiting until at least 2 months of age for the first dose if the vaccine is not given at birth.

The hepatitis B shot is typically given to infants as a three-dose series. Typically, after the first dose is given within 24 hours of birth, children get the second dose at 1 to 2 months, and the third between 6 to 18 months of age.

Some panel members expressed concern about vaccinating during the neonatal period, a critical window of development for the brain and immune system — despite the fact that the hepatitis B vaccine has been safely given to newborns for decades. Others said they had not seen data to support delaying the dose until two months or older.

“We have to make decisions with the data that we have, and we must use only the credible data to make the decisions, and not speculations and not hypotheses,” said ACIP member Dr. Joseph Hibbeln, a psychiatrist and neuroscientist.

Ahead of the vote, representatives from liaison groups urged the panel to reconsider changing the current recommendation.

“This vote is an unnecessary solution looking to find a problem to solve,” said Dr. Jason Goldman, president of the American College of Physicians, addressing the panel members directly. “It will not fix your concerns of informed consent, but only endanger children.”

Dr. Amy Middleman, a representative for the Society for Adolescent Health and Medicine, noted that the CDC’s infectious disease experts could not vet misinformation before it was presented to the public.

“As a hep B researcher, I can confirm there has been a lot of misinformation presented in the last couple of days,” Middleman said.

Acting CDC Director Jim O’Neill, a former investment executive who also served at the federal health department under President George W. Bush, but does not have a medical background, will now choose whether to adopt the panel’s recommendations.

The panel did not change the current recommendation to vaccinate newborns whose mothers test positive for hepatitis B or whose infection status is unknown. Hepatitis B can be transmitted from mother to child during delivery, and can lead to liver disease, cancer and death.

Kennedy fired the panel’s previous members in June and replaced them with a group that has largely expressed skepticism of vaccines. Because of this shakeup, many states have started to ignore its guidance and defer instead to recommendations from professional societies or newly formed public health alliances.

Public health experts worry the new recommendations will make guidance around hepatitis B vaccines less clear to providers and patients, since it does not strongly advocate for vaccinating newborns.

“The more confusing we make these recommendations, the harder this is going to be for clinicians to implement,” said Chari Cohen, president of the nonprofit Hepatitis B Foundation.

Food and Drug Administration Commissioner Marty Makary told NBC News in a sit-down interview Thursday that the evidence does not support a universal birth dose for hepatitis B.

“When a parent wants to wait until the child is 8, 10 or 12 years of age, we have to listen to those parents and be honest with them that there is no scientific evidence that there’s a benefit of doing it on the first day of life versus at age 10 or 12,” he said.

Many doctors and public health experts strongly disagree. Not all pregnant women get tested for hepatitis B, so public health experts say that delaying the shots could lead to more infections.

Cases of acute hepatitis B plummeted among children after the CDC began recommending a universal birth dose in 1991. A CDC analysis of children born from 1994 to 2023 estimated that hepatitis B vaccination prevented more than 6 million infections and nearly 1 million hospitalizations.

On Tuesday, the Vaccine Integrity Project — a University of Minnesota initiative dedicated to safeguarding vaccine use in the United States — published a review of more than 400 studies that found no evidence of short- or long-term health problems from the hepatitis B shot after birth. Though not published in a peer-reviewed journal, the paper was reviewed by major medical societies including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Infectious Disease Society of America.