CDC advisers delay planned vote on hepatitis B vaccine for infants : Shots

Vaccine advisers to the Centers for Disease Control and Prevention on Thursday unexpectedly postponed a controversial vote on changes to current recommendations for universal newborn immunization against hepatitis B. Confusion and disagreement over the wording of the votes led the Advisory Committee on Immunization Practices (ACIP) to push them to Friday.

The committee meeting was marked by unusual conflict and chaos.

“This is the third iteration of questions we've 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 object to the statement that ACIP members were consulted in developing these issues.”

The vote was aimed at overturning a long-standing recommendation that all healthy newborns be vaccinated against hepatitis B, regardless of whether the mother tests positive or negative for the virus. But the language of the vote changed between the time it was released Friday morning and the afternoon, and some panel members wanted more time to review it in writing.

The current recommendation is designed to ensure that no at-risk child is left behind and to provide lifelong protection for all children in the United States against the hepatitis B virus, which can cause serious, potentially fatal health problems. This is the cornerstone of a multi-year strategy. to eliminate hepatitis B in the USA

Hepatitis B, which is often transmitted through sexual contact and drug use, can be passed from mothers to babies during childbirth and in infancy through contact with body fluids of an infected person, such as 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 become infected in infancy. There is no cure.

During Thursday's discussion, there was a clear split between some participants who were in favor of changing the recommendation and others who were against the change.

Dr. Tracy Beth Hoeg, a spokeswoman for the Food and Drug Administration, questioned the need for the current one-size-fits-all policy.

“Children born without high-risk factors, without an antigen-positive mother, without a family member with hepatitis B — for these children the potential benefit is very small,” said Hoeg, who was named acting director of the FDA's Center for Drug Evaluation and Research on Thursday. “Why do we say that it is absolutely necessary to give this dose at birth, when in high-income countries around the world this is not the case?”

Dr. Cody Meissner, a professor of pediatrics at Dartmouth's Geisel School of Medicine, defends the current policy.

“This disease has declined in the United States due to the effectiveness of our current immunization program,” said Meissner, who is the only current member who has served on the committee in the past. When another adviser, Robert Malone, a vaccinologist and biochemist, challenged him to call the statement his “opinion,” he responded, “These are facts, Robert.”

Representatives of medical professional groups, without voting rights, opposed the process, which differs from how ACIP typically operates.

“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 needed to make such informed decisions,” said Dr. Jason Goldman, a spokesman for the American College of Physicians. “Your job as a committee is to look at the totality of risks and benefits, harms and justices that you have not done.”

The postponement leads to a busy agenda on Friday. In addition to voting on changes to hepatitis B policy, the committee plans to discuss how the U.S. vaccination schedule compares to other countries, as well as the connection between aluminum – an ingredient used in more than a dozen vaccines to improve their effectiveness – and asthma.

Most medical professionals say there is no conclusive evidence that aluminum adjuvants are unsafe and enough evidence that they do not pose a real problem.

Many public health experts are concerned that this week's actions are part of a concerted effort to undermine access to vaccines in the United States.

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

But after Kennedy, the committee lost the confidence of most leading medical groups. replaced its members in June with your own tablet. The committee has also abandoned longstanding collaborations with medical groups such as the American Academy of Pediatrics and is relying less on the expertise of CDC experts.