During a Fox News interview with Martha MacCallum, FDA Commissioner Dr. Marty Makary acknowledged that while vaccines save lives, not all should be treated the same. He argued that the evidence for an immediate hepatitis B vaccine at birth is less clear than for other shots like measles or polio.
“I personally don’t believe that the evidence is solid to say the hep B shot needs to be given at birth,” Makary said on Monday. “It’s a sexually transmitted infection you’re trying to prevent. Kids are not sexually active until they are of age, so a lot of parents say I will wait until they are 10, 11, or 12. If the mom is hep B positive, that is different, but these are nuanced issues.”
“We believe in vaccines, but does that mean people need the anthrax vaccine? No. It was a disaster and taken off the market. One of the viruses, disaster, and taken off the market,” he added.
Makary emphasized that he broadly supports vaccines, describing them as “tried-and-true,” but urged flexibility for families who prefer vaccine schedules in countries like Japan or Germany.
“The government is not your doctor,” he said.
Other health leaders have warned against shifting U.S. policy. Dr. Demetre Daskalakis, who recently stepped down from the CDC’s National Center for Immunization and Respiratory Diseases, told ABC’s This Week that delaying the hepatitis B vaccine could put infants at risk if their mothers’ hepatitis status is unknown.
“We have one bite at that apple so that child gets that important hepatitis B vaccine,” Daskalakis said. He cautioned that childhood hepatitis B can lead to cirrhosis and liver cancer later in life.
CDC models estimate that about 0.5% of United States births — 20,000 to 25,000 infants annually — are to mothers with hepatitis B, out of roughly 3.6 to 3.7 million births each year in the United States. Those most at risk include people who inject drugs, men who have sex with men, close contacts of infected individuals, healthcare workers, people with HIV or on dialysis, and incarcerated populations.
The Advisory Committee on Immunization Practices, which was recently restructured under Health and Human Services Secretary Robert F. Kennedy Jr., is scheduled to meet Sept. 18–19. The panel will debate recommendations for hepatitis B, COVID-19, and measles vaccines, and could vote on whether to modify the newborn hepatitis B policy.
Sen. Rand Paul (R-KY) has also questioned the need for the universal hepatitis B birth dose. In a Fox News interview on Tuesday, he argued that the vaccine should be limited to newborns whose mothers test positive for hepatitis B.
“The only reason to give your newborn a hepatitis B vaccine is if the mom has hepatitis B,” Paul said. “Instead, the government has said everybody … has to have hepatitis B vaccine, but there’s no science to support that. That’s what’s led to this hesitancy, and it’s what’s led to this distrust.”
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Paul linked the broader debate to concerns about COVID-19 vaccines, saying government messaging has been inconsistent and at times misleading. “Parents instinctively know that’s wrong, so they begin to doubt all vaccines,” he said.
The September ACIP meeting is expected to be a flashpoint in the ongoing battle over vaccine guidelines, with federal officials, physicians, and parents closely watching whether recommendations for newborn hepatitis B shots will change for the first time in decades.
