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FDA Chief Says No Solid Evidence Supporting Hepatitis B Vaccine at Birth
The head of the U.S. Food and Drug Administration (FDA) 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 (CDC) 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.
Former CDC Director to Come Before Senate in First Public Appearance Since Firing
Former Centers for Disease Control and Prevention (CDC) Director Susan Monarez will come before the Senate next week for her first public appearance since she was pushed out of her position, sparking a back-and-forth with Health and Human Services Secretary Robert F. Kennedy Jr. over his vaccine policy agenda.
Monarez will be joined by Deb Houry, former chief medical officer and deputy director for program and science at CDC, who was one of four top CDC officials who resigned in protest after Monarez was ousted. The hearing will be on Sept. 17 at 10 a.m.
The two former officials will testify before the Senate committee on Health, Education, Labor and Pensions (HELP), which is chaired by Republican Sen. Bill Cassidy, a doctor from Louisiana who was one of the key votes to confirm Kennedy but has since become one of his sharpest critics in the Republican Party.
RFK Jr. May Link Vax Aluminum Adjuvant and Autism, Former FDA Chief Says
Scott Gottlieb, M.D., who served as FDA commissioner from 2017 to 2019 during President Donald Trump’s first term, expressed concern about the future of the U.S. pediatric vaccine schedule in an interview with CNBC on Monday. Notably, Gottlieb said during the interview that he believes the U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. could use a forthcoming agency report to claim an association between alum — an aluminum-based adjuvant used in some vaccines — and autism, and that this claim could ultimately “take down the whole pediatric vaccine enterprise.”
Gottlieb explained that the adjuvant is “used in about 10 vaccines,” and that there is “no good alternative.” He added that vaccine manufacturers could be forced to reformulate the vaccines and decouple them, so instead of having the combination measles-mumps-rubella vaccine, they would have to be given separately — which means more shots for kids.
“If they start to decouple these things, it would force a lot of more interactions with the healthcare system,” Gottlieb said. “It’s going to put pressure on vaccination rates overall.”
Two Vaccination Systems: ACOG vs. CDC and the Growing Divide in U.S. Public Health
When the American College of Obstetricians and Gynecologists (ACOG) reaffirmed its recommendation that pregnant and lactating individuals receive updated COVID-19 vaccines, it did more than issue clinical guidance. It broke with the U.S. Centers for Disease Control and Prevention (CDC), which recently removed pregnancy from its COVID-19 vaccine recommendation schedule.
The move underscores a growing reality TrialSite has been tracking: the U.S. now operates under two parallel vaccination systems — one led by federal agencies like CDC and the U.S. Food and Drug Administration under Robert F. Kennedy Jr., and another emerging from professional associations, independent networks, and advocacy initiatives such as the Vaccine Integrity Project.
ACOG insists that pregnancy remains a high-risk condition and that updated boosters protect both mother and infant through transplacental antibodies. Their data citations emphasize reduced hospitalization and better outcomes for infants under six months. The CDC, however, has shifted its stance, limiting recommendation language and tightening eligibility to “high-risk” categories. That leaves pregnant women in an ambiguous policy space: federally, not prioritized; clinically, strongly urged to vaccinate.
