CDC Vaccine Panel Scraps Guidance for Universal Hepatitis B Shots at Birth

CDC Vaccine Panel Drops Guidance for Universal Hepatitis B Vaccines at Birth

By Lauren J. Young edited by Tanya Lewis & Claire Cameron

An influential vaccine advisory group voted Friday to change recommendations for the hepatitis B vaccine for newborns. According to the group’s new guidelines, which the Centers for Disease Control and Prevention almost always adopts, parents should consult a health care provider about when to give their baby their first dose of vaccine, provided the person who gave birth to the baby has tested negative for the disease. This would reverse the CDC’s current policy of all babies receiving the hepatitis B vaccine within hours of birth. The vote passed with eight votes in favor and three against.

New guidelines from the Advisory Committee on Immunization Practices (ACIP) recommend that the three-dose vaccination regimen begin no earlier than two months of age for these infants. ACIP members also passed a second vote to recommend that parents discuss subsequent doses with a health care provider based on blood tests of the newborn’s immunity levels (protective antibody titers).

“I’ll just say: We’ve heard that do no harm is a moral imperative. We’re doing harm by changing that wording. And I’m voting no,” ACIP member and pediatric infectious disease epidemiologist Cody Meissner said in the first of three votes presented at today’s meeting.

The CDC did not immediately respond to requests for comment from Scientific American.

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Public health experts have expressed concern about the lack of data to support the proposed schedule for vaccination and warned that delaying the initial dose would increase vulnerability to hepatitis B infection.

That two-month period “is the time a child is at risk for vaccine-preventable disease,” says Helen Chu, a physician and immunologist at the University of Washington and former ACIP member.

The decision comes after several meetings filled with heated debate and admitted confusion among members over what they were voting on. The panel had postponed the vote twice, first at a meeting in September and again on Thursday. The deliberations sparked a “public outcry,” Chu said. Many public health experts and medical societies are “pretty clear that they don’t want to eliminate the birth dose,” she says.

At the meetings, several ACIP members argued that newborns whose biological parent tested negative for the virus are at “low risk” of contracting the disease and that the decision to get vaccinated should be an individual right. Currently, states require people to receive certain vaccines in order to attend public school or work certain jobs. Some members also raised concerns about side effects and limited data on vaccine safety, despite dozens of CDC studies and reviews that have demonstrated the hepatitis B vaccine is safe and highly effective at preventing infections in infants.

Today’s vote is a departure from a vaccine policy established in 1991 that significantly reduced hepatitis B rates in children, according to a review of 400 studies released earlier this week.

“The vaccine has virtually eliminated childhood hepatitis B in the United States, and so it’s really devastating to think about losing that,” says Yvonne Maldonado, a pediatrician at Stanford University School of Medicine and a former ACIP member.

ACIP decisions directly affect access to vaccines. Children’s vaccines are covered either by private health insurance or by Vaccines for Children (VFC), a federal program for which about half of children in the United States are eligible. Private and public insurers, including VFC, fully cover ACIP-recommended vaccines through a shared clinical decision-making process. But public health experts have expressed concern that ACIP’s discussions and new shared decision-making recommendations will end up weakening people’s ability to receive the vaccine.

“When you remove the strength of that recommendation, pregnant women may or may not be offered this vaccine,” Rochelle Walensky, a former CDC director and now a senior researcher at Harvard University, said on a press call Thursday. “They may or may not have a discussion about the importance of their newborn being vaccinated. And that may go unnoticed in terms of access.”

Hepatitis B is a highly contagious viral disease that damages the liver. Chronic cases can lead to liver disease or liver cancer. The virus is spread through bodily fluids, including blood and semen. The disease has been stigmatized because people associate it with unprotected sex and injecting drug use, but the virus can also be transmitted during pregnancy, during childbirth and through close contact with bodily fluids after birth.

“In my career, I’ve seen children with hepatitis B. I’ve seen children die of liver failure, which is a horrible death. I would never wish that on anyone,” Maldonado says.

About 18,000 infants and children were infected with hepatitis B each year before the vaccine was recommended for all newborns in the United States, according to Children’s Hospital of Philadelphia. The guidelines called for three doses of vaccine: the first was given to infants at birth, the second was given between one and two months of age, and the third was given between six and 18 months of age. The birth dose helps prevent infection in the first weeks or months of life, Maldonado says. And the regime was effective: cases from 1990 to 2019 fell by 99 percent.

Delaying the first dose until the second month for infants born to pregnant parents who test negative for the virus or whose infection status is unknown could cause an additional 1,437 childhood infections, 304 cases of liver cancer and 482 hepatitis B-related deaths, a recent preprint paper suggests.

Public health experts note that the success of the updated recommendation depends on effective hepatitis B screening of pregnant women. The CDC recommends that all pregnant people be tested for hepatitis B, preferably during the first trimester. But these tests can fail because hepatitis B can be “a silent infection,” Maldonado says.

In the United States, only 84 to 88 percent of pregnant women are tested for the virus; more than 80 percent of people are unaware they are infected. False negatives can occur if the test is performed incorrectly or if a person has been infected very recently. And other caregivers, such as family members and daycare workers, who might not be screened could also be carrying the virus, Maldonado says.

“The simplest, safest and most effective way to protect all babies in this country is to give them this dose at birth, plus the next two doses, which will protect them for virtually their entire young adult life,” she adds.

Editor’s note: This is a developing story and may be updated.