ACIP revises recommendation for universal infant vaccination against hepatitis B

The Advisory Committee on Immunization Practices (ACIP) revised its recommendation for universal infant vaccination against hepatitis B.

In a larger sense, the panel also must weigh public health, personal autonomy, patient informed consent and parental authority over children, ACIP’s vice chair said.

The deliberations came on Dec. 5, the second day of ACIP’s two-day meeting. The panel voted to uphold the recommendation for infants born to women who test positive for hepatitis B, or whose status is unknown.

For infants born to women who test negative, “ACIP recommends individual-based decision-making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose.”

“Parents and health care providers should consider vaccine benefits, vaccine risks and infection risks,” the vote language said. “For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.” There was a second vote regarding recommending parents consult health care providers to evaluate the need for subsequent HBV vaccine doses in children, including potential testing and insurance coverage for it.

ACIP makes its recommendation to the director of the U.S. Centers for Disease Control and Prevention (CDC).

ACIP and the hepatitis B vaccine: recommendations, mandates and patient informed consent

ACIP postpones vote on hepatitis B vaccines at birth

‘Conflicting points of view’

To start deliberations, ACIP member Vicky Pebsworth, PhD, RN, presented the vote language. Her fellow members jumped into an hour of debate about the science and policy of hepatitis B vaccines for newborns.

That discussion included allusion to a core issue: the right to self-determination, and striking the right balance between maximizing the greatest good for the greatest number, while respecting the rights of individual self-determination, said ACIP Vice Chair Robert Malone, MD, MS. Frontline physicians deal with it all the time — focusing on the right and interests of particular patients in front of them, while aware of public health policy to maximize the greatest good for the greatest number.

“My personal bias is to err on the side of enabling individual decision making and individual rights over the rights of the collective,” Malone said. “That's my personal preference, and I think that that is at the heart of what we're dealing with here.”

It is not a trivial thing, he added.

“I think, to be honest, we're torn by these two conflicting points of view and that doesn't mean that we're wrong or those that disagree are wrong,” Malone said. “It means that there are these two fundamental differences of opinion about the rights of individuals versus the rights of society and the goals and objectives of society, and it seems to me that that is the essence of what we're dealing with.”

ACIP members speak

Some of the discussion dealt with biologic reactions, some with patient relations, some with the nuance of language to be sent to the director of the U.S. Centers for Disease Control and Prevention.

ACIP member Hillary Blackburn, PharmD, MBA, said supported the intent of maintaining strong protection against hepatitis B, while empowering parents to work with their pediatricians. She noted the vote language introducing serology testing would be a new practice, and said she had concerns about feasibility.

ACIP member Retsef Levi, PhD, said the new policy would reject an existing policy “that relies on the principle that everybody should be receiving the same care when it comes to vaccination, and based on really a sense of fear that everybody is in the same level of risk, a sense of we need to treat or use babies and children as safety net, and that essentially vaccines are risk free.”

“And I think that the alternative policy is saying something very different, very different,” he said.

Babies born to mothers with hepatitis B absolutely are recommended to take the vaccine that is effective and will protect them against serious outcomes of a serious disease, Levi said. For babies born to mothers who don’t have hepatitis B and who have low risk of exposure early in life, parents must consider the risk of the disease and the potential health effects of a vaccine, he said.

Parents are told vaccines are completely safe, but they have not been tested appropriately, Levi said. He compared the shots to aircraft safety — no one would fly on a untested plane, even if the vendor assured it was safe.

ACIP member Catherine M. Stein, PhD, agreed with the necessity of vaccination for children born to mothers with hepatitis B. For those low-risk infants, discussion and policy gets at the point of informed consent, vaccine mandates and prohibitions for children who are not vaccinated, she said.

In comments of Dec. 4, ACIP affiliate representatives affirmed informed consent and discussion with parents are key parts of their medical practices, and that is commendable, Stein said. ACIP was not recommending any changes regarding insurance coverage, so access to the shots should not be a concern, she added.

ACIP member Joseph Hibbeln, MD, ABNP, Capt. USPHS (Ret.), pointed to the 2-month age recommendation in the vote language. ACIP delayed voting on a hepatitis B recommendation for months, but received no new information or science on that, Hibbeln said, and he called it “unconscionable” to vote on that. Adding a serology test before the full series of vaccines are administered is an absolutely novel concept that was not debated or supported with evidence, but that would create new barriers to achieve protection.

ACIP member H. Cody Meissner, MD, said thoughtful inquiry is commendable, but should not be confused with baseless skepticism, which the panel was encountering. If the vaccine causes harm that outweighs benefits immediately after birth, there should be evidence about why that changes at 2 months, he said. For the language of Vote 2, he said it “is kind of making things up, I mean, it’s like never never land,” establishing levels for testing serology that could demonstrate immunity at less than 3 months.

Meissner said Levi’s analogy about airplane safety was not accurate.

“We know vaccines are safe,” Meissner said. “There's no question that the COVID recommendations were dishonest and disingenuous, but the hepatitis B vaccine recommendation is very well established, we know is safe, and we know is very effective, and to make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis B.”

ACIP Chair Kirk Milhoan, MD, PhD, said neonates are a very protected class at higher risk for almost every medical procedure. Using an abundance of caution, waiting two months gets the infant out of the neonatal period, he said.

The question becomes how to have the maximum amount of benefit from vaccines while doing everything you can to limit the risk, and the vaccines do have some risk, Milhoan said.

The other ACIP members are Evelyn Griffin, MD; James Pagano, MD, FACEP; and Raymond Pollak, MD, FACS, FRCS. Discussion included comments from Tracy Beth Hoeg, MD, PhD, acting director of the Center for Drug Evaluation and Research; and Adam Langer, DVM, MPH, principal deputy director (acting) and associate director for science at CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention.