Vaccine advisers to the Centers for Disease Control and Prevention unexpectedly postponed controversial votes Thursday on changing the longstanding recommendation to universally immunize newborns against hepatitis B. Confusion and disagreement over the vote language led the Advisory Committee on Immunization Practices (ACIP) to move the votes to Friday.
Committee members described the meeting as unusually conflicted and chaotic. “This is the third version of the questions that we have received in 72 hours, and we’re trying to evaluate a moving target,” said Dr. Joseph Hibbeln, a psychiatrist and voting member. “I protest the description that the ACIP members have been consulted in developing these questions.”
The planned vote centered on ending the decades-old policy of vaccinating all healthy newborns against hepatitis B regardless of maternal infection status. The vote wording changed several times between its posting Friday morning and early afternoon, and some members requested more time to review the revised language in writing.
The current universal recommendation aims to ensure no at-risk infant is missed and to provide lifelong protection against hepatitis B, a virus that can cause serious, potentially fatal liver disease. It has been the foundation of a long-term strategy to eliminate hepatitis B in the U.S. Hepatitis B is often spread sexually and through injection drug use, but it can also be transmitted from mother to infant at birth and in infancy through contact with infected body fluids. Chronic infection increases the risk of liver cancer, cirrhosis and death, with far higher risks when infection occurs in infancy. There is no cure.
Discussion at the meeting revealed a pronounced split. Dr. Tracy Beth Høeg, representing the Food and Drug Administration, questioned the need for a universal birth dose. “Babies who are born without high risk factors, without a mother who is antigen positive, without a family member who has hepatitis B – for these babies, the potential for benefit is so low,” Høeg said. She noted that many high-income countries do not require the dose at birth.
Dr. Cody Meissner, a pediatrics professor at Dartmouth’s Geisel School of Medicine, defended the current policy. “This disease has gone down in the United States, thanks to the effectiveness of our current immunization program,” Meissner said. When fellow adviser Robert Malone, a vaccinologist and biochemist, pressed him to label that statement as opinion, Meissner replied: “These are facts, Robert.”
Nonvoting liaisons from medical groups criticized the process as departing from ACIP’s usual approach. “As physicians, your ethical obligation is to ‘first, do no harm’ and you are failing in that by promoting this anti-vaccine agenda without the data and evidence necessary to make those informed decisions,” said Dr. Jason Goldman, a liaison for the American College of Physicians. “Your job as a committee is to look at the totality of the risks and benefits, the harms, the equity, which you have not done.”
The postponement creates a packed Friday agenda. Along with the hepatitis B vote, ACIP will consider how the U.S. vaccine schedule compares to other countries and review potential links between aluminum vaccine adjuvants—used in more than a dozen vaccines to boost effectiveness—and asthma. Most medical professionals say there is no solid evidence that aluminum adjuvants are unsafe and that they pose no meaningful concern.
Public health experts worry these moves could be part of an effort to undermine vaccine access in the U.S. ACIP recommendations carry significant influence over clinical practice and vaccine coverage by insurers. The committee’s credibility with mainstream medical groups has eroded since new leadership replaced members in June with a slate chosen by Kennedy. ACIP has also stepped back from longstanding collaborations with groups like the American Academy of Pediatrics and is drawing less on CDC experts’ experience.
