Hepatitis B vaccine is optional, not universal, for low-risk infants, CDC says

Individual-based decision-making will be the basis for vaccinating infants against hepatitis B if they are born to women to test negative for the virus, according to the U.S. Centers for Disease Control and Prevention (CDC).

The policy announced De. 16 formalizes the recommendation made earlier this month by the Advisory Committee on Immunization Practices (ACIP). The new policy overturns the recommendation for universal newborn vaccination against hepatitis B. That practice had been in place since 1991 and experts argued it not only protected babies, but had led to such a sharp decline in hepatitis B that eradication might be in sight for the United States.

"This recommendation reflects ACIP's rigorous review of the available evidence," Acting CDC Director Jim O’Neill said in a news release. He also serves as deputy secretary of Health and Human Services (HHS) and is a top aide to HHS Secretary Robert F. Kennedy, Jr. "We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B."

Who makes the decision?

For infants not receiving the birth dose, the initial dose should be administered no earlier than 2 months of age, according to the CDC policy. The centers’ announcement also included an explanation about how physicians and patients should determine the appropriateness of the shots.

“Individual-based decision-making, referred to on the CDC immunization schedule as shared clinical decision-making, means that parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks, and that parents consult with their health care provider and decide when or if their child will begin the hepatitis B vaccine series,” the CDC announcement said. “Parents and health care providers should consider whether there are infection risks such as a household member who has hepatitis B or frequent contact with persons who have emigrated from areas where hepatitis B is common.”

A CDC fact sheet on the policy acknowledged the vaccine “remains a safe, effective tool for preventing serious liver disease in infants at risk.”

AMA response

In the ACIP meeting, commenters included Sandra Adamson Fryhofer, MD, a trustee of the American Medical Association (AMA). The association issued a statement from her responding to the CDC policy.

“Decades of scientific evidence shows that the birth dose of the hepatitis B vaccine is essential to protecting all newborns from a serious, chronic infection that can lead to liver disease, cirrhosis, liver cancer, and even death,” Fryhofer said. “Rolling back this recommendation creates confusion and doubt about vaccines, reverses hard-won progress in preventing hepatitis B, and will undoubtedly result in completely preventable illness and death. Physicians continue to recommend the birth dose of the hepatitis B vaccine for all newborns, and we encourage parents with questions about vaccines to talk to their physician.”

Truly informed patients?

Earlier this month, ACIP conversation touched on determining whether, at time of birth, new mothers and fathers were fully informed that newborns would get the hepatitis B vaccine. Everyone generally agreed that on that occasion, there is an urgent need for swift medical attention and family emotions may be running high. ACIP members Evelyn Griffin, MD, an obstetrician and gynecologist, and Retsef Levi, PhD, said notice about the hepatitis B vaccine could get lost amid the rush of medical treatments and accompanying paperwork.

There was discussion about chances of transmitting the disease to babies. ACIP did not change the recommendation to vaccinate infants born to women who test positive for the disease, which attacks the liver. Discussion included comments from physicians and patients who described the health effects of the disease, and no one argued those health conditions were insignificant. Vaccine health effects on children also were part of the deliberations.

Children at risk

Earlier this month, the American Academy of Pediatrics (AAP) publicized findings by the Vaccine Integrity Project of the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP). A review of more than 400 studies and reports led to the conclusion that delaying the birth dose would lead to more infections, but no changes to the vaccine’s safety or effectiveness.

Since 1991, pediatric hepatitis B incidence has dropped 99%, that study said. At least 17,000 infants are born each year to women with the disease, but the vaccine and hepatitis B immune globulin can reduce transmission from mother to child by 83% to 97%, the study said.

The CIDRAP study reported 18% of pregnant women do not receive hepatitis B testing, and only 35% of women who test positive receive all recommended follow-up care.

In the ACIP meeting, members agreed the nation needs a better rate for testing pregnant women for the disease. A CDC fact sheet about the hepatitis B vaccine recommendation noted screening has high reliability and stated: “Pregnant women should get tested for the hepatitis B virus. This test is covered across all insurance programs.”

AAP said the CIDRAP findings showed ACIP should not change the recommendation for universal birth doses. AAP President Susan J. Kressly, MD, FAAP, wrote to ACIP that the hepatitis B vaccine “has one of the most well-established safety records of any vaccine.”

“Switching to a non-universal recommendation will result in many children contracting hepatitis B infection, with devastating results for their health,” she wrote.