CDC Moves to Limit Hep B Shots for Newborns After Advisory Panel Vote

Vaccine advisers for the US Centres for Disease Control and Prevention (CDC) voted on 5th December morning to limit hepatitis B vaccines in what labelled a major move by the Trump administration in its regressive approach to vaccines that have been given safely and well for decades.

The panel of advisers, hand-picked by the US health secretary, Robert F Kennedy Jr, agreed to take down the well-established and far-reaching recommendation that all newborns in the US should be administered a hepatitis B vaccine.

The committee voted to recommend that when the child is an infant, the parents of infants whose mothers test negative for hepatitis should make the decision to give their infant the series, in consultation with a healthcare professional. Consulting with doctors was already a norm in vaccination.

The move on Friday will introduce confusion into routine vaccinations and access problems, particularly for lower-income families, experts said. While the advisers make non-binding recommendations, they often form the foundation of official policy, and they directly impact how the private and federal insurance providers cover the vaccines.

Donald Trump welcomed the long-standing recommendation being scrapped and signed a memo to review aligning child immunization recommendations with best practices from “peer, developed countries”.

“This is going to lead to an increase in preventable infections in children,” said Michaela Jackson, program director of prevention policy at the Hepatitis B Foundation. The vote is “taking choice away by making it impossible to access” and “parents are not going to know who to trust anymore,” she said.

Hepatitis B vaccines still are recommended to kids whose mothers test positive for the virus, the advisers said. The shots for most infants at birth will now be “shared clinical decision-making”, the advisers decided, voting 8-3 although this is a term which is poorly defined and is usually reserved for non-routine vaccines.

We have heard “do no harm” is a moral imperative. “We are doing harm by changing this language,” said Cody Meissner, professor of pediatrics at the Geisel School of Medicine at Dartmouth College, who is widely regarded as the most experienced member of the committee and who strongly opposed the change.

Adding language around shared clinical decision-making “creates barriers to care”, said Natasha Bagdasarian, a practicing infectious disease physician and liaison to the meeting for the Association of State and Territorial Health Officials. “Many healthcare providers draw from it that the vaccine is controversial, that they need to take more steps or that they might be exposed to more liability.”

If a parent is not able to get their child the vaccine at birth, the advisers recommend waiting at least two months.

“Some parents may hold back on getting the birth dose, but they may arrive at two weeks or a couple days after birth,” said Judy Shlay, a liaison attending the meeting for the National Association of County and City Health Officials. “We should not restrict that.”

The recommendations will now go to Jim O’Neill, acting director of the CDC, who will consider changing the US official policy on the hepatitis B vaccines.

Independent medical bodies like the American Academy of Pediatrics strongly urge all infants to be vaccinated up to 24 hours after birth.

The advisers also recommended giving blood tests on infants once they have their first shot, to see if they need more shots. It is an approach not studied, and it is unclear if it would be possible for the blood-test to indicate the levels of protection offered by the three-shot course.

Suggesting that providers order a blood test, and having insurers cover blood tests, is beyond the scope of the vaccine advisory body.

Delay in giving the shot from birth to two months would result in at least 1,400 infections, 300 cases of liver cancer, and 480 deaths annually, according to a recent model. The 5-year survival rate of liver cancer is 18% in the United States.

More than half of people who are infected with hepatitis B do not know where they have contracted the virus. Exposures can occur in the home among family and friends, at daycare, while playing sports, and even having to share nail clippers or jewelry because the virus can still be infectious on surfaces for up to a week.

The Vaccines for Children program (4), which covers the vaccinations of 52% of children in the US, must follow the recommendations of the ACIP. Changing these guidelines makes it more difficult for families in this program to have access to the shots, experts said.

The second day of the ACIP meeting started 20 minutes early and was soon in a flammable mood, over whether it was “unconscionable” to hold a vote on hepatitis B vaccines without more information. The advisers already managed to delay the vote three times, requesting to arrive with more information and more time to amend wording in the vote.

“In addition to this not being discussed, there has been no data presented that this plan would actually work,” said Joseph Hibbeln, an adviser and neurologist formerly at the National Institutes of Health.

One of the votes “is kind of making things up”, Meissner said. “I mean, it is like Never Never Land.”

He pushed back on claims by other advisers that hepatitis B vaccines are administered to compensate for “adults’ mistakes and flaws in our healthcare system”, as Retsef Levi, an adviser and professor of operations management at the MIT Sloan School of Management, said.

“We’re giving it to protect the infant against a potentially fatal disease,” Meissner said. “We know it’s safe and we know it’s very effective and to make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis b.”