CDC advisers delay planned vote on hepatitis B vaccine for infants

Vaccine advisers to the Centers for Disease Control and Prevention unexpectedly postponed controversial votes Thursday on changes to the current recommendation of universally immunizing newborns against hepatitis B. Confusion and disagreement over the language of the votes led the Advisory Committee on Immunization Practices, or ACIP, to push them to Friday.

The committee meeting was marked by unusual conflict and chaos.

“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 of the committee. “I protest the description that the ACIP members have been consulted in developing these questions.”

The vote was intended to focus on ending a longstanding recommendation to vaccinate all healthy newborns against hepatitis B, regardless of whether the mother tests positive or negative for the virus. But the language of the vote was changed between the time it was posted Friday morning to the early afternoon and some members of the group wanted more time to consider it in writing.

The current recommendation is intended to make sure no at-risk infant falls through the cracks, and to confer lifelong protection for all U.S. children against the hepatitis B virus, which can cause serious, potentially fatal health problems. It is the cornerstone of a decades-long strategy to eliminate hepatitis B in the U.S.

Hepatitis B, which is often spread through sexual contact and drug use, can be transmitted from mothers to infants during childbirth, and in infancy through contact with an infected person’s body fluids, such as their blood.

The virus attacks the liver and chronic infection can lead to liver cancer, cirrhosis and death. The risks of these outcomes are much higher for people who get infected as infants. There’s no cure.

In Thursday’s discussion, there was a pronounced split between some of the attendees who spoke in favor of changing the recommendation and others who were against a change.

Dr. Tracy Beth Høeg, a representative for the Food and Drug Administration, questioned the need for the current universal policy.

“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,” said Høeg, who was named as acting director for the FDA’s Center for Drug Evaluation and Research on Thursday. “Why are we stating that it is absolutely necessary to give this dose at birth, when high income nations throughout the world are not?”

Dr. Cody Meissner, a professor of pediatrics 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,” said Meissner, who is the only current member that has served on the committee in the past. When challenged by another adviser, Robert Malone, a vaccinologist and biochemist, to caveat this statement as his “opinion,” he replied: “These are facts, Robert.”

Nonvoting liaisons from medical professional groups spoke out against the process, which deviates from how ACIP usually works.

“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 leads to a packed agenda on Friday. In addition to the vote to change the hepatitis B policy, the committee is scheduled to discuss how the U.S. vaccine schedule compares to that of other countries, and the links between aluminum – an ingredient used in more than a dozen vaccines to make them more effective – and asthma.

Most medical professionals say there’s no good evidence that aluminum adjuvants are unsafe and ample evidence that they pose no real concern.

Many public health experts are concerned that this week’s moves are part of a concerted effort to undermine vaccine access in the U.S.

The CDC’s advisory committee wields enormous power because its recommendations influence how doctors vaccinate patients and dictate whether insurance companies pay for shots.

But the committee has lost the trust of most mainstream medical groups since Kennedy replaced its members in June with his own slate. The committee has also abandoned longstanding collaborations with medical groups like the American Academy of Pediatrics and draws less on the experience of CDC experts.