ACIP votes to delay hepatitis B vaccine

ACIP's new recommendation is that mothers who test negative for hepatitis B during their pregnancy should discuss with their doctors whether to give the hepatitis B vaccine at birth, or at all, and those who choose to give their child the vaccine should wait until their baby is at least two months old.

The vote won't change the policy for babies born to mothers who tested positive for hepatitis B during pregnancy or whose hepatitis B status isn't known. These babies should still receive a dose of a vaccine within 12 hours of birth and a dose of hepatitis B immune globulin.

The vote also won't affect insurance coverage for hepatitis B shots, nor will it affect coverage through the Vaccines for Children Program, according to CDC.

ACIP's decision still needs to be endorsed by acting CDC Director Jim O'Neill or by HHS Secretary Robert F. Kennedy Jr. before it will become part of CDC's vaccination schedule.

Since 1991, CDC has recommended that all babies receive a dose of a hepatitis B vaccine at birth. All pregnant people are supposed to be tested for hepatitis B during their pregnancy. However, testing doesn't always occur, some tests can be faulty, and some pregnant people can be infected during pregnancy after they're tested.

After the birth dose policy was enacted in 1991, the number of infants and babies testing positive for hepatitis B dropped from the thousands into the single or low-double digits.

The birth dose of hepatitis B has been a target of vaccine critics, including Kennedy who falsely claimed on a podcast in June that it was a "likely culprit" of autism.

ACIP's decision to review the hepatitis B vaccination recommendation was not prompted by any new safety or efficacy concerns but rather by parents concerned about the shot, the fact that most European countries give the shot a few months after birth, and the length of time since ACIP reviewed the topic, panelists said.

During the meeting, ACIP panelists voting against the birth dose claimed  that the risk to most babies was very low and that hepatitis B mainly is a disease of sex workers, drug users, and immigrants from countries with high infection rates.

Levi also falsely claimed that experts had "never tested [the vaccines] appropriately" and said the committee shouldn't recommend any timeline for the shot.

ACIP's vice chair, Robert Malone, framed the debate over the vaccine as a "diversity of opinion regarding the existence of evidence of harm" and said questions about harms were "largely unresolved due to a lack of data."

Multiple studies have found the hepatitis B vaccine is not associated with any increased risk of infant death, fever or sepsis, multiple sclerosis, or autoimmune conditions.

Cody Meissner, an ACIP member who is a pediatrician, said there is plenty of data suggesting the vaccine is safe and that the risk of the virus to babies is real.

A recent report that has yet to be peer reviewed or published in a medical journal estimated that delaying the hepatitis B vaccine by two months could result in at least 1,400 hepatitis B infections in children and 480 deaths, and that the toll would be higher if the first dose was given even later.

"We've heard 'do no harm' as a moral imperative. We are doing harm by changing this wording," Meissner said. He was joined by Joseph Hibbeln, a psychiatrist and neuroscientist, and Raymond Pollak, a surgeon and transplant specialist, in voting against the recommendation.

"This is a very dangerous decision," Campbell said. "It will certainly cause harm."

Ulrich von Andrian, president of the American Association of Immunologists, said in a statement that the organization is "extremely disappointed" in ACIP's decision.

"Delaying the vaccine would mark a dangerous departure from decades of achievement in preventing hepatitis B infection and its complications. Recent independent analysis warns that even a modest delay could result in a substantial increase in preventable chronic infections, liver cancers, and deaths," he said. "Now is not the time to undermine confidence in one of the most successful vaccine-based public health interventions in modern history." 

Trump orders review of childhood vaccination schedule

Shortly after ACIP's decision, President Trump issued a memorandum ordering federal officials to review the childhood immunization schedule and consider recommending fewer shots, calling the United States an "outlier" for recommending vaccinating children against 18 diseases and questioning the practice of giving children annual flu shots.

Specifically, the memo directs HHS and CDC to "review best practices from peer, developed countries for core childhood vaccination recommendations — vaccines recommended for all children — and the scientific evidence that informs those best practices, and, if they determine that those best practices are superior to current domestic recommendations, update the United States core childhood vaccine schedule to align with such scientific evidence and best practices from peer, developed countries while preserving access to vaccines currently available to Americans."

In a post on Truth Social, Trump said the United States recommends "far more" shots to children than necessary. "In fact, it is ridiculous!" he wrote. "Many parents and scientists have been questioning the efficacy of this 'schedule,' as have I!"

"I am fully confident in Secretary Robert F. Kennedy Jr., and the CDC, will get this done, quickly and correctly, for our Nation's Children," Trump added.

In a post on X, Kennedy responded to the memo, saying, "Thank you Mr. President. We're on it."

Jose Romero, a pediatrician on AAP's infectious diseases committee, noted that American children "are at risk of different diseases than children in other countries."

"We also have a completely different health system," Romero said. "The bottom line is vaccine recommendations in the United States are designed to help children resist serious illnesses so they can stay healthy, and our communities can stay healthy."