CDC adopts advisers’ recommendation against universal hepatitis B vaccines for babies

By Katherine Dillinger, CNN

(CNN) — The US Centers for Disease Control and Prevention officially abandoned universal hepatitis B vaccination for newborns on Tuesday, signing off on its vaccine advisers’ recommendation for individual decision-making — a move that experts and researchers say will lead to more illness.

The changes are the most significant yet by the members of the CDC’s Advisory Committee on Immunization Practices, or ACIP, who were handpicked by US Health and Human Services Secretary Robert F. Kennedy Jr. after he removed all 17 previous members this summer.

Hepatitis B vaccination had been recommended for all infants in the US since 1991, a move that helped slash infections in children from an estimated 18,000 cases per year to about 20. Before the new recommendations, the CDC vaccine schedule advised the first dose at birth, a second dose at 1 month or 2 months, and a third at 6 months to 15 months.

The CDC will now recommend shared decision-making with health care providers for mothers who test negative for the virus and are deciding when to have their children vaccinated against hepatitis B, including at birth. If the vaccine isn’t given at birth, they suggest waiting until a child is at least 2 months old.

“This recommendation reflects ACIP’s rigorous review of the available evidence,” acting CDC Director Jim O’Neill said in a statement Tuesday. “We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B.”

The CDC is still reviewing the advisers’ vote in favor of testing children for immunity to hepatitis B when parents and health care providers are determining whether the child might need subsequent vaccine doses.

However, hepatitis B vaccination shortly after birth has never been mandatory, and doctors argued it was already a discussion between providers and parents. Universal vaccination for newborns is still recommended by major medical groups such as the Infectious Diseases Society of America and the American Academy of Pediatrics.

“Since the ACIP voted to downgrade the recommendation for a birth dose of hepatitis B vaccine, pediatricians are already reporting more parents declining to give their child this critical dose,” AAP President Dr. Susan Kressly said in a statement. “As a pediatrician, this is heartbreaking when we have a vaccine that can prevent so many infections, and it is deeply disappointing to see the continued dismissal of expertise to inform recommendations that have broad implications on the health of America’s children.”

Hepatitis B is a liver infection caused by an extremely infectious virus. It’s transmitted through blood or genital fluids from an infected person and can be passed easily during childbirth from a woman to her child during either a vaginal delivery or C-section. However, it can also spread through bites or scratches, such as when children are playing.

After an acute hepatitis B infection, many adults clear the virus. But acute infection can lead to chronic hepatitis B, which is linked to increased risk of liver cancer, organ failure and cirrhosis, or scarring of the liver. People with chronic hepatitis B are 70% to 85% more likely to die early.

Infants and children who are infected with hepatitis B are more likely to develop chronic disease, including about 90% of infants and 30% of children ages 1 to 5.

The new votes should not change the availability of hepatitis B vaccines, and insurers and officials have said that parents who want to get their children vaccinated against hepatitis B will still be able to do so at no cost.

However, experts say the shifting approach will create confusion that could have serious consequences.

The wording of the new recommendations will signal to providers that there’s something risky about the vaccine even though it has been shown to be “exquisitely low risk” over decades of testing and widespread use, said Dr. Demetre Daskalakis, former director of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. Retsef Levi, an ACIP member who is a management professor at MIT, said at the panel’s meetings two weeks ago that the new recommendations are intended to put more choice in the hands of parents. “I think that the intention behind this is that parents should carefully think about whether they want to take the risk of giving another vaccine to their child, and many, many of them might decide that they want to wait far more than two months, maybe years and maybe up to adulthood. I think that’s going to be up to them and their physician.”

But other members were critical of the changes.

“We are doing harm by changing this wording,” said Dr. Cody Meissner, a pediatrician at Dartmouth University, who said he hopes doctors will continue to vaccinate newborns before they leave the hospital.

“I think to follow any other course is not in the interest of the infant,” he said. “There is no evidence of harm, and there’s no reason to think that the outcome would be different if the vaccine were administered at 2 months of age instead of 1 month of age, except for, there will be more children who will be injured, who will catch the infection.”

A recent modeling study suggests that delaying babies’ hepatitis B vaccines for even a few months will drive up infections, long-term health complications and deaths. The researchers behind the analysis, which has not been peer-reviewed or published in a medical journal, had previously developed hepatitis B vaccination models to inform ACIP decisions.

The analysis found that delaying the birth dose to 2 months for infants whose mothers test negative for hepatitis B could lead to hundreds of additional infections per year.

Major medical groups such as the American Medical Association had urged O’Neill to reject the ACIP recommendations, as did Sen. Bill Cassidy, a Louisiana Republican who cast a pivotal vote to confirm Kennedy as HHS secretary.

“As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake,” Cassidy posted on X.

“The hepatitis B vaccine is safe and effective. The birth dose is a recommendation, NOT a mandate,” he noted. “Ending the recommendation for newborns makes it more likely the number of cases will begin to increase again. This makes America sicker.”

CNN’s Brenda Goodman, Meg Tirrell and Jamie Gumbrecht contributed to this report.

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