Interview with Scott Gottlieb on Recent Public Health Changes
MARGARET BRENNAN: We’re discussing recent changes to U.S. public health policy with former FDA commissioner Dr. Scott Gottlieb, who is currently on the boards of Pfizer and United Healthcare. Welcome back.
DR. SCOTT GOTTLIEB: Thank you.
MARGARET BRENNAN: On Friday, the American Academy of Pediatrics expressed deep concern over the CDC vaccine advisory panel’s 8-3 vote to change a 30-year policy on Hepatitis B vaccination for newborns. They now recommend postponing the dose until the child is two months old, instead of administering it within the first 24 hours of birth. What does this mean for families with newborns?
DR. SCOTT GOTTLIEB: Well, it’s important to understand why the birth dose is given. For many parents, the idea of their newborn getting vaccinated right after birth can be unsettling. However, for kids over five, if they contract Hepatitis B, they have about a 95% chance of clearing it and gaining lifelong immunity. In contrast, for children aged one to five, the chance drops to about 25-50%. Sadly, about a quarter of those will develop chronic infections, leading to severe outcomes. When it comes to newborns, the stakes are even higher; 90% of infected newborns will develop chronic infections, and about 25% could die from complications like liver disease. By providing this birth dose, we have a unique opportunity to almost eliminate the risk of Hepatitis B in newborns—it’s nearly 99% effective.
MARGARET BRENNAN: And this decision means delaying the dose for two months?
DR. SCOTT GOTTLIEB: Yes, exactly.
MARGARET BRENNAN: The President has said that delaying the vaccine is fine since Hepatitis B is transmitted mainly through sexual contact or unclean needles.
DR. SCOTT GOTTLIEB: That view is quite misleading. The reality is that many mothers aren’t tested for Hepatitis B during pregnancy, even if they had intended to. Test results can be overlooked, and there’s also a false-negative rate of about 2%. While that may seem minor, it could mean that at least 1,000 infants would be born and potentially infected. There’s a model predicting that under this new guidance, 1,400 infants could contract Hepatitis B in the first year. Again, a quarter of them could die from that infection.
MARGARET BRENNAN: There’s a broader scrutiny of vaccines right now, particularly with the Trump administration and decisions made by this board that was made public. Some of the dissenting voices from the panel argued that the CDC is causing harm and that there has been no rational science presented. What does that suggest about future decisions?
DR. SCOTT GOTTLIEB: This advisory group, ACIP, has a number of members who are aligned with anti-vaccine sentiments. The Secretary has openly stated his goal to roll back childhood immunizations, which is troubling. This is a significant misstep because ACIP was once a respected body many states depended on for making health decisions. As it stands, its credibility is being undermined, and some states have already chosen not to follow its guidance. This will impact insurance coverage as well, as companies may start relying on organizations like the American Academy of Pediatrics instead of ACIP.
MARGARET BRENNAN: Recently, there’s been a notable drop in biotech stocks following reports that the FDA plans to change its approval protocols for vaccines, now requiring one study for approval. You previously expressed concerns that this could hinder vaccine development. What specific issues do you see?
DR. SCOTT GOTTLIEB: The current head of vaccine division, Vinay Prasad, has announced plans to move away from so-called immuno-bridging studies that have historically allowed us to demonstrate vaccines’ effectiveness based on antibody production. This approach has been crucial for maintaining annual vaccines, like the flu shot, that need updating to match circulating strains. If this approach changes, updating vaccines on a seasonal basis may no longer be feasible.
MARGARET BRENNAN: A group of former FDA commissioners voiced serious concerns over recent actions, particularly relating to Covid vaccine reports connecting it to the deaths of at least ten children. They said this was significant and raised questions about whether the vaccine saved more healthy children than it harmed. The current administration hasn’t provided data to back these claims. What inquiries would you pose to the FDA commissioner regarding this situation?
DR. SCOTT GOTTLIEB: Well, first off, it’s crucial to differentiate between findings of tragic cases and the decision-making that follows. Policy changes shouldn’t stem from isolated incidents without careful review. Each of these cases needs thorough examination. While it’s unfortunate to see any suspected vaccine-related deaths, these cases should be analyzed comprehensively. The current FDA might not have examined the detailed case data that the previous organization did, and it would be prudent for them to share that information publicly for transparency.
MARGARET BRENNAN: HHS has indicated that they will eventually release that data. We’ll keep an eye out for it, Dr. Gottlieb. Thank you for your insights today. We’ll be right back.
