FDA panel votes against approving vaccine boosters

the panel of experts assessing boosters for the FDA just voted 16-2 AGAINST recommending booster shots for pfizer. (early reports of 16-3 were incorrect)

given some of the craziness we’ve seen this year (like aduhelm) where the FDA overrode a unanimous panel and approved anyhow, this is not a 100% reason to believe they will not do it (or try to modify it, perhaps for age groups) but given the politicization of this issue and the klieg light glare of attention, they i suspect they have to play it pretty straight.

retiring staffers grueber and krasuse stood very tall here despite being repeatedly told to shut up. this just drives home why they are leaving.

but many others stood up too.

they foregrounded severe safety issues in the public comments.

and this is hard to ignore. thank you jessica, we’ve all been watching this, glad you said it when it mattered.

and note that this is not adjusted for VAERS under-reporting. the real figures could well be 10X this, especially in light of the games being played around reporting.

lots of discussion here:

and already talk of “let’s find something else to approve” here:

but make no mistake, this was a nasty black eye for pfizer. they walked in unprepared with a tiny, 300 person dataset. they tried to get the panel to consider data not in in the trial (this is a wild move). they assumed this was a rubber stamp pushover because everything else has been.

but maybe, just maybe, the FDA is remembering what its job is and maybe the endless public scrutiny and opprobrium heaped on them for doing such haphazard, slapdash, and politicized work is forcing them back onto the straight and narrow.

(and if so, we owe marion grueber and philip krause (retiring director and deputy director respectively of the FDA office of vaccines research and review) a serious debt of grattitude.)

and just maybe we’re going to demand science first and policy second again.

because one thing is manifestly clear: if the FDA approves boosters for 16 and up after that panel, they will blow whatever remains of their credibility to smithereens and lose any remaining tatters of their claim to be “on the side of science” and not of politics.

pfizer got gutted in there and backing them in spite of it would subject the FDA to the same fate.