FDA Chief Says No Solid Evidence Supporting Hepatitis B Vaccine At Birth

Authored by Zachary Stieber via The Epoch Times,

The head of the Food and Drug Administration said on Sept. 8 that there is no strong evidence supporting the administration of a hepatitis B vaccine to infants.

“I personally don’t believe that the evidence is solid to say the Hep B shot needs to be given at birth,” Dr. Marty Makary, the FDA commissioner, said during an appearance on Fox News.

“It’s totally different from polio and measles, and some of these other shots that are tried and true and have been around for a long time.”

The FDA, which is part of the Department of Health and Human Services, has cleared hepatitis B vaccines to be administered at birth. The Centers for Disease Control and Prevention recommends that all infants receive a hepatitis B vaccine on the day they are born.

A debate among some doctors regarding the recommendation has been taking place in light of the CDC vaccine advisory panel’s scheduled discussion on the hepatitis B vaccination at its upcoming meeting.

“I predict that what they’re going to do is try to change the birth dose of hepatitis B vaccine so that kids don’t get it when they’re born,” Dr. Demetre Daskalakis, who recently resigned from the CDC, said during an appearance on ABC.

The panel makes recommendations on vaccines. The recommendations are usually adopted by the CDC.

Hepatitis B is a liver infection that can lead to liver failure and death, although some of those infected never experience symptoms. Hepatitis B is contracted through contact with the bodily fluids of an infected person. Babies who are born to infected women can also contract it.

The CDC first recommended the hepatitis B vaccine in 1982, the year after it was cleared, for people deemed to be at high risk, such as drug users, pregnant women, and infants born to mothers who had hepatitis B.

By 1992, the recommendation for infants shifted to the first day of life and was broadened to all newborns because of “the difficulty of vaccinating high-risk adults,” according to the CDC.

Three doses of the vaccine are on the CDC’s childhood immunization schedule, and nearly every state requires hepatitis B vaccination to attend school and/or childcare facilities.

The stated goal of the vaccination campaign was to eliminate transmission of hepatitis B, which has not happened.

“We’re giving about 11 million doses of hepatitis B a year, and pretty much all of them are for kids who we know don’t need it,” since their mothers have been screened, Dr. Monique Yohanan, a senior fellow at Independent Women’s Forum, told The Epoch Times in a recent interview.

Health Secretary Robert F. Kennedy Jr. testifies before the Senate Committee on Finance on Capitol Hill in Washington on Sept. 4, 2025. Madalina Kilroy/The Epoch Times

Yohanan, in a recent paper, advised officials to move hepatitis B vaccination from infancy to adolescence because it would reduce early exposure to aluminum, a vaccine adjuvant, and provide immunity in the period when people are more at risk.

A 2022 study in Thailand found that a majority of people who were vaccinated as infants no longer had antibodies against hepatitis B 16 to 28 years after vaccination.

Martin Kulldorff, chair of the CDC’s vaccine advisory committee, said during the reconstituted panel’s first hearing in June that “unless the mother is hepatitis B positive, an argument could be made to delay the vaccine for this infection, which is primarily spread by sexual activity and intravenous drug use.”

“It’s a sexually transmitted infection you’re trying to prevent. Kids are not sexually active until they’re of sexual age. So, a lot of parents say we’re going to wait until they’re 10, or 11, or 12,” Makary said on Thursday on Fox.

“Available data show that vaccine-induced antibody levels decline with time,” the CDC states on its website.

“However, immune memory remains intact for more than 30 years following immunization, and both adults and children with declining antibody levels are still protected.”

The agency did not respond to a request for citations by publication time.

The Preventive Services Task Force and the CDC recommend screening pregnant women for hepatitis B. Some states mandate such screening. About 84 percent of pregnant women receive pre-birth hepatitis B testing, according to a 2017 study.

Vaccine proponents such as Sen. Bill Cassidy (R-La.), a doctor, have noted that some women are not screened and that there can be false negatives for women who are tested.

Sen. Roger Marshall (R-Kan.), an OBGYN whose profile says he delivered more than 5,000 babies, said during a Sept. 4 hearing in Washington that giving the hepatitis B vaccine at birth “makes no sense to me.”

“We do a hepatitis test on every mom. By the time she delivers that baby, I know her pretty well. And if she doesn’t have any risk factors—if she’s not an IV drug abuser, if she’s in a stable, monogamous relationship, nobody at home has hepatitis—I don’t see the benefit myself in that hepatitis vaccine,” he said.

Makary said it’s different when a mother tests positive for hepatitis B, while Marshall said that pregnant women who receive no prenatal care and thus are not tested are at risk.

“If you have a mother who is well-connected to care—you know her hepatitis B status—that may not matter very much,” Daskalakis said.

“But if you have a mother who’s not gone to prenatal care, who comes in to deliver, we have one bite at that apple so that child gets that important hepatitis B vaccine.”