FDA Vaccine Approval Policy Changes

This week, we saw a big sell-off in biotech stocks following these reports that the FDA,

which you used to run at the first part of the Trump administration, is now going to require

one study to clinch approval of vaccines. You were one of the former commissioners who put out this

really extraordinary editorial in the New England Journal of Medicine arguing that the FDA and top

vaccine regulator Dr. Vinay Prasad are changing policies in a way that's going to slow down

new and better vaccines. What specifically is the problem you see? Because this isn't just

hep B, this is the vaccines of the future you're saying just won't be created.

Right. 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 immunobridging 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 a 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

longstanding practice. 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.