CDC vaccine advisers’ new focus on hepatitis B tests in pregnancy is not enough, some doctors warn

By Jacqueline Howard, CNN

(CNN) — Many medical organizations and frontline health care providers are grappling with a challenge they haven’t had to face in many years: how to protect newborns against hepatitis B.

Last week, a federal advisory panel reversed its longstanding recommendation for universal vaccination at birth. Instead, the panel decided to rely on a mother’s test results for hepatitis B during pregnancy. The babies of women who test positive should still be vaccinated shortly after birth, the vaccine advisers said, and if the test is negative, parents should make a decision with their health-care provider on whether or when to vaccinate the child. Vaccinations would still be available to families who want them and insurance should still cover them, members of the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices said.

But relying on testing recalls an approach the United States tried in the 1980s and early ’90s that still led to thousands of cases of hepatitis B among children every year.

Even with universal vaccination for newborns as the standard, universal testing for hepatitis B during pregnancy remained an important part of prenatal care in the United States for decades. The ACIP decision puts even more emphasis on that practice, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

“It places a spotlight on testing,” he said. “Testing for hepatitis B virus is currently a standard part of prenatal care. It’s recommended to be tested in the first trimester or at the earliest first prenatal visit to get that answer as soon as possible. If a woman doesn’t have any prenatal care, then it’s often tested at delivery.”

Some critics of ACIP’s decision argue that vaccinations always have been a shared decision between parents and health-care providers, and they worry that the shift could sow confusion and ultimately discourage parents from vaccinating their children altogether.

It could mean testing carries the burden of hepatitis B prevention.

Testing alone will not work as an approach for hepatitis B prevention, said Dr. James Campbell, a pediatrician at the University of Maryland School of Medicine and vice chair of the American Academy of Pediatrics’ Committee on Infectious Diseases. History has shown that some women may not have access to testing or just don’t get any prenatal care. The test may be falsely negative, or mothers could become infected after they get tested.

“My worry is that more Americans will believe we no longer need to pay attention to hepatitis B in children, and we will return to the time when many babies and young children were infected every year,” Campbell wrote in an email.

Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said he fears that the new ACIP recommendation could lead more parents to rely on testing alone and could dissuade them from getting their newborns the birth dose of hepatitis B vaccine, leaving the infant potentially vulnerable to an infection – even if they are determined to be at low risk of the virus.

“I worry a little bit that this is going to send a message that it’s really not a concern and if you have your hepatitis B testing early in pregnancy and you’re not high-risk, you don’t need to do this,” said Fleischman, an associate chief of the Department of Obstetrics and Gynecology at Yale New Haven Hospital.

“But even though you’re low-risk, you’re not no risk,” he said. “Even if there’s a minute risk that this could impact your baby, why wouldn’t you get this vaccine, which has for years been shown to be very safe?”

‘The ultimate safety net’

Hepatitis B is a serious bloodborne viral infection that primarily attacks the liver. Many adults may clear an acute infection on their own, but acute infection can persist to chronic hepatitis B, which is linked with an increased risk of liver cancer, organ failure and cirrhosis, or scarring of the liver, and even death.

The first vaccines against the hepatitis B virus were developed in the early 1980s. Around that time, ACIP recommended pre-exposure vaccination initially for people at high risk of infection, such as men who have sex with men, injection-drug users and heterosexual persons with multiple partners. Despite this recommendation, some people at high risk were still not vaccinated, and infections spread, including in children.

The risk of chronic infection is highest among young children, with about 90% of infected infants and 30% of children infected between ages 1 to 5 estimated to remain chronically infected with hepatitis B.

In 1988, ACIP recommended that all pregnant women be screened routinely for hepatitis B.

A blood test is the only way to know if someone is infected, because many people with hepatitis B may not look or feel sick. They may spread the virus unknowingly, through blood or other body fluids.

But testing alone did not work as efficiently as vaccinations in preventing hepatitis B, especially in children, said pediatrician Dr. Michael Warren, March of Dimes’ chief medical and health officer.

“Testing during pregnancy really focuses on one mode of transmission, and that’s the mother-to-baby transmission, typically around the time of birth. That testing essentially doesn’t account for those cases of exposures after birth, so those cases that may be caused by exposure from other caregivers,” Warren said.

For example, hepatitis B can spread if an infected caregiver has an open cut or sore and handles a pacifier before putting it in the baby’s mouth.

“The other thing is, we know that some women may fall through the cracks and not get tested, or the test may not be 100% accurate,” he said. “Some things may get missed, including making sure the testing is done or even making sure a baby is getting all the care that they need. So making sure that we get testing done is key for addressing transmission at birth, but that birth dose of vaccine gives us protection for those exposures that may come after. It really is the ultimate safety net.”

By 1991, the United States’ hepatitis B vaccination strategy had evolved. ACIP recommended broader efforts to eliminate transmission in the United States, with a focus on universal childhood vaccination at birth or shortly after, the prevention of mother-to-baby transmission of the virus, vaccinating adolescents and adults in high-risk groups, and catch-up vaccinations for susceptible children in high-risk populations.

At the time, some pediatric-care providers were hesitant to accept the ACIP recommendation that all newborns be vaccinated. However, by 1996, efforts to educate providers and parents about hepatitis B and the benefits of vaccination led to broader acceptance.

According to data from the CDC, from 1993 through 2000, the national coverage rate for hepatitis B vaccine among babies ages 19 to 35 months rose from 16% to 90%.

“Back when the vaccine was first introduced in the ’80s and the approach was to only vaccinate babies who were born to women with hepatitis B, you were still seeing these later cases of hepatitis B in infancy, childhood and adolescence, because there are these other sources of exposure,” Warren said. “And so that birth dose of hepatitis B helps protect babies right from the start.”

A ‘crucial part’ of prevention

The testing of pregnant women for hepatitis B has remained a “crucial part” of preventing infections among newborns, said Campbell, from the American Academy of Pediatrics’ infectious disease committee.

“There are many tests available, but the one primarily being discussed in this context is hepatitis B surface antigen. It is a blood test that is quite accurate at detecting persons infected with the hepatitis virus,” Campbell wrote in an email.

This CDC advisory panel’s recommendations won’t become final until Jim O’Neill, the agency’s acting director, signs off. The CDC typically aligns with it advisers, but some doctors and lawmakers have urged O’Neill to reject their decision and maintain the recommendation for universal vaccination.

When the CDC’s recommendations are final, many medical organizations will probably re-examine their own individual guidelines for hepatitis B testing in pregnancy, said Fleischman, the ACOG president.

“We’re going to probably have a conversation at our institution about do we want to consider additional hepatitis B surface antigen screening later in pregnancy,” he said. “It’s a conversation that’s probably happening among many obstetricians and hospitals.”

Despite potential changes to CDC’s recommendation, the American Academy of Pediatrics and ACOG still continue to recommend that all babies get hepatitis B vaccinations in the first day of life, even if their mothers tested negative.

Some research suggests that after the strategy to vaccinate children at birth was introduced, the incidence of hepatitis B infections among infants and young children each year declined from roughly 16,000 cases in the early 1990s to fewer than 20 in recent years.

“We’ve got now this history that shows that when we introduce the birth dose of hepatitis B vaccine, that the cases of hepatitis B among infants dropped by 99%,” said Warren, of March of Dimes.

“And we had not seen that before, even when there were risk-based recommendations,” he said. “This is a public health intervention that has been shown to be wildly successful.”

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