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

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

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.

By Zachary Stieber

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