Former FDA commissioner on new vaccine recommendations for children and new guidelines

(CBS, KYMA) - Former FDA Commissioner Dr. Scott Gottlieb spoke with Margaret Brennan on Face the Nation Sunday about the new vaccine recommendations for children.

According to Brennan, the American Academy of Pediatrics is "deeply alarmed" that the CDC vaccine advisory panel, Advisory Committee on Immunization Practices (ACIP), voted 8-3 to change a 30-year long policy regarding Hepatitis B and newborns.

ACIP, according to Brennan, is now recommending delaying a dose until a child is two months old instead of 24 hours after they are born.

This prompted Brennan to ask Dr. Gottlieb, who also serves on the Pfizer and UnitedHealthcare boards, what the new recommendations mean for families of newborns, to which Gottlieb said:

"I think we first need to understand why we give that birth dose of the vaccine, because the idea of giving a vaccine to a newborn, to a lot of parents, sounds discomforting, that the first thing a child is going to face when they're born is going to be a vaccine within the first 24 hours. For a child over the age of five, if they develop Hepatitis B infection, if they're exposed to it, they're going to have a 95% chance of clearing that infection, and they'll go on to develop lifelong immunity. For children between the ages of one and five, they only have about a 25 to 50% chance of clearing the infection, so about 25 to 50% of kids will develop chronic infection, and about a quarter of them will go on to die from hepatitis B if they're between the ages of one and five. So children are more vulnerable to this virus and can't clear the infection. But when you're talking about a newborn, an infant, 90% of newborns who become infected, and they'll become infected during delivery, will go on to develop chronic infection, they won't be able to clear the hepatitis B, and about 25% of them will die from sequelae of that infection, either from liver disease, cirrhosis or from liver cancer. So we have this unique opportunity by giving this birth dose and the subsequent inoculations to virtually eliminate the chance that a newborn can contract Hepatitis B and go on to develop chronic infection, it's almost 99% effective at preventing that chronic infection."

During the interview, Brennan and Gottlieb talked about new vaccine guidelines, with Brennan saying there was a "big sell off in biotech stock" following reports that the FDA is going to require one study to clinch approval of vaccines.

Brennan also said Gottlieb was one of the former commissioners who wrote an editorial for the New England Journal of Medicine, arguing the FDA and Dr. Vinay Prasad, who is the top vaccine regulator, are "changing policies in a way that's going to slow down new and better vaccines."

When asked what the problem he sees specifically, Gottlieb said:

"So Vinay Prasad, who is the head of the Biologic Center, also oversees the Vaccine Division. He also has been appointed the head of biostatistics, the Chief Medical Officer of the agency, and chief scientific officer. So he occupies a lot of positions. Put out a memo saying that they're going to do away with, or move away from, what they call immuno bridging studies. These are studies that allow you for well validated vaccines, like the flu vaccine, to be able to demonstrate each year that the vaccine, the new vaccine, that's formulated against the circulating strain, can elicit antibodies that are effective against that particular strain, and that could be the basis of approval, rather than requiring new outcome studies every year to prove that the vaccine actually reduces the incidence of influenza. For established vaccines, where we know that antibody production is a good correlate for immunity, this has been a long standing practice. It's, we do it for flu vaccine, we do it in covid Certainly, we do it for things like pneumococcal vaccine, the vaccine for pneumococcal disease, where we look at serotypes circulating bacterial serotypes. This allows us to update vaccines as these viral and bacterial strains change, and as the composition of the strains change in time to provide protection for the Fall respiratory season. If they move away from this, which is what he said, they plan to do, we're just not going to be able to update vaccines each season, as we've done historically, to accommodate whatever the circulating strain is."

To watch more of Brennan's interview with Gottlieb, click here.