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

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

FDA Commissioner Dr. Marty Makary in Washington on April 22, 2025. Andrew Harnik/Getty Images

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.