FDA Changes Impact on Vaccine Approvals

This week we saw a, a big selloff in biotech stocks, um,

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

gonna slow

down new and better vaccines.

What specifically is the problem you see? 'Cause this isn't just Hep B.

This, 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 the chief scientific

officer, so he occupies a lot of positions,

put out a memo saying that

they're gonna 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.

It's, we do it for flu vaccine, we do it in COVID certainly, we do it for,

um, things like pneumococcal vaccine, the vaccine for pneumococcal disease,

where

we look at serotypes, uh, 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

gonna be able to update vaccines each season as we've done historically to

accommodate whatever the circulating strain is.