Confusion over CDC panel’s hepatitis B guidance could disrupt care for babies

Doctors, hospitals and public health departments are struggling to provide adequate care for pregnant women and their babies after a controversial vote by Centers for Disease Control and Prevention consultants changed decades of standard medical practice of vaccinating newborns against hepatitis B.

“We don't yet know how individual hospitals and physicians will handle this,” said Dr. Brenna Hughes, interim chair of the department of obstetrics and gynecology at Duke University in Durham, North Carolina. “It breeds fear and mistrust.”

Last Friday, the Centers for Disease Control and Prevention's (CDC) vaccine panel recommended that only babies born to women who test positive for hepatitis B should receive the first dose within 24 hours of delivery. The decision ends decades of recommendations that all newborns should be protected from a lifelong, incurable infection that can lead to liver disease and cancer.

However, many babies in the United States are born to women who have never had the opportunity to get tested.

A March of Dimes Report Research published in November found that nearly a quarter of pregnant women are not under medical care during the first trimester, when most women are tested for hepatitis B.

Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the hepatitis B vaccine given to newborns acts as a safety net.

“If someone becomes infected with hepatitis B later in pregnancy or develops the infection later,” Fleischman said, “the baby will be protected by this vaccine.” The virus can be transmitted from mother to child during childbirth.

As of Tuesday, acting CDC Director Jim O'Neill had not yet signed off on the committee's recommendation. The agency is not required to follow the commission's recommendations, but typically does so.

The CDC does not require vaccination. It recommends a schedule for protecting children from infectious diseases. The Vaccine Commission regularly reviews the data and makes changes to the schedule based on recommendations from doctors or scientists with expertise in the field.

But experts said the advisory group, made up of members selected in June by the Department of Health. Robert F. Kennedy Jr. failed to provide scientific evidence historically associated with the Centers for Disease Control and Prevention (CDC) to support his arguments.

The group “did not follow the standard and transparent process that has made the advisory committee a bastion of effective, evidence-based decision making,” said Dr. Jason Goldman, an internal medicine physician and president of the American College of Physicians. “Their information and decisions cannot be trusted.”

The group recommended that women who test negative for hepatitis B can decide, after consultation with a health care professional, whether their baby should receive a dose at birth.

The panel's vote to delay hepatitis B vaccine for infants until they are at least 2 months old for the first dose if the vaccine is not given at birth is completely against the grain decades of evidence proving the vaccine is safe and effective, experts say. The birth dose introduced for all infants in the early 1990s reduced cases of acute hepatitis B in children by 99%.

On a call with reporters Tuesday, Dr. Aaron Milstone, a pediatrician at Johns Hopkins Medical Center and a member of the American Academy of Pediatrics' committee on infectious diseases, said the result is “chaos and confusion” among public health experts trying to advise doctors on best practices, as well as doctors in exam rooms dealing with worried parents.

“Many physicians work across our country in fear that doing the best for their patient now conflicts with information coming from previously trusted sources,” Dr. Sara Nosal, president of the American Academy of Family Physicians, said during the same call.

“If you have to spend 20 minutes explaining that vaccines, yes, are actually safe,” said Dr. Kevin Shulman, a professor of medicine at Stanford University School of Medicine, “then we don't spend 20 minutes making sure that the child is on the growth curve, that you're wearing a seat belt, that you're using car seats correctly.”

Dr. Anna Locke, director of clinical hepatology and associate dean for clinical research at the University of Michigan Medical School, said the change in guidance adds barriers for parents, especially in a chaotic delivery room.

“We're just telling parents, 'We're going to make you climb Mount Everest to get your child vaccinated,'” Locke said. “Because every step, every obstacle is just a guarantee that what needs to be done will not be done.”

Dr. Rashmi Roa, an obstetrician and gynecologist who specializes in high-risk pregnancies at UCLA, says nothing has changed medically. “Our recommendations will remain the same.”

Some states are bypassing federal guidelines and instead joining forces to develop their own guidelines. Dr. Naima Joseph, an obstetrician-gynecologist at Beth Israel Deaconess Medical Center in Boston, said health officials in Massachusetts and other states have formed the Northeast Public Health Organization.

“We have already made recommendations for a universal birth dose of hepatitis B vaccine that continues to ensure availability” for newborns, she said.

A measured approach isn't expected across the country, said Joe Zamboni, an attorney for the nonprofit American Families for Vaccines. “I think some states will probably do it better than others,” he said.

One state that has public health experts concerned is Florida. State Surgeon General Joseph Ladapo said in September that Florida is working to eliminate all vaccine requirements for children to go to school.

The Florida Department of Health has planned meeting this Friday, December 12th.to discuss these requirements. An agency spokeswoman told NBC News in an email that the meeting will take place in Panama City and will not be available to the public online.

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