Scott Gottlieb Warns ACIP Hepatitis B Shift Could Put Newborns At Risk — And Flags Broader Vaccine Policy Changes

Former FDA commissioner Dr. Scott Gottlieb, who serves on the boards of Pfizer and UnitedHealthcare, discussed major shifts in U.S. vaccine policy in a Dec. 7, 2025, interview on Face the Nation with Margaret Brennan. The conversation focused on the Advisory Committee on Immunization Practices (ACIP) decision to delay the Hepatitis B birth dose, concerns about the committee's composition, and recent FDA policy moves that could affect future vaccine development.

Why the Birth Dose Matters

Brennan opened by noting that ACIP voted 8–3 to change a decades‑long recommendation: instead of routinely administering the Hepatitis B vaccine within 24 hours of birth, the committee now recommends delaying the first dose until two months of age. Gottlieb explained the rationale for the original policy.

Infants who acquire Hepatitis B at birth are far more likely to develop chronic infection than older children. Gottlieb summarized the age-related risk: children older than five clear infection about 95% of the time, children aged one to five clear it roughly 25%–50% of the time, and about 90% of newborns infected at delivery develop chronic disease. Chronic Hepatitis B can lead to cirrhosis and liver cancer; an estimated ~25% of those chronically infected as infants eventually die from these complications.

Gottlieb emphasized that the birth dose followed by the routine infant series is highly effective — nearly 99% — at preventing chronic infection when given on schedule.

Concerns About Relying On Maternal Testing

The new ACIP recommendation leans on detecting infected mothers during pregnancy to decide who needs a birth dose. Gottlieb cautioned that prenatal screening is imperfect: some pregnant people are not tested, results may not be reviewed or recorded reliably, and the tests themselves have a measurable false‑negative rate (he cited an estimated ~2%). Even a small false‑negative rate can translate to hundreds or thousands of undetected maternal infections and exposed infants. Gottlieb referenced a modeling study projecting roughly 1,400 infant infections in the first year under the new guidance, with a significant proportion at risk of long‑term complications.

Politics, ACIP Credibility, And Downstream Effects

Brennan raised concerns about the composition of ACIP and public statements at the meeting. Some critics have argued that the panel includes vaccine skeptics and that the meeting was influenced by anti‑vaccine advocacy. Gottlieb said that the committee’s credibility has been damaged and warned that state and insurer reliance on ACIP recommendations may diminish: historically many state laws (he cited about 600) referenced ACIP guidance, and he noted that a number of states have moved to decouple from ACIP recommendations while some insurers said they would rely on professional societies such as the American Academy of Pediatrics instead.

FDA Policy Shifts And Implications For Vaccine Development

The interview also covered internal FDA changes that prompted a sell‑off in biotech stocks. Gottlieb described a memo from a senior FDA official indicating a move away from immunobridging studies — a regulatory approach that allows updated vaccines (for well‑characterized products) to be authorized based on immune response data rather than new large outcome trials. Immunobridging has long enabled timely updates for seasonal influenza vaccines and other products when antibody responses are accepted correlates of protection. Gottlieb warned that abandoning or restricting immunobridging could slow the ability to update vaccines quickly to match circulating strains.

Adverse Events, Transparency, And Next Steps

Brennan cited reports that career FDA staff had identified a number of pediatric deaths reported in temporal proximity to COVID vaccination. Gottlieb urged caution: temporal association in spontaneous reports does not establish causation, and each case requires careful, case‑level adjudication. He called for the FDA to publish the underlying case‑level analyses so outside experts can scrutinize the evidence. HHS has said it will make relevant data public; Gottlieb and the interviewer both said they will watch for those disclosures.

Bottom line: The ACIP decision to delay the Hepatitis B birth dose raises public‑health concerns about infant vulnerability, while simultaneous changes inside the FDA and questions about ACIP’s composition could reshape vaccine policy, regulatory practice, and public confidence. Experts and public‑health authorities will be watching forthcoming data and analyses closely.

Note: This article summarizes a broadcast interview and related reporting. The interview included statements from Scott Gottlieb reflecting his perspective; readers should weigh those views alongside official CDC, FDA and peer‑reviewed sources.