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FDA panel votes against approving vaccine boosters
el gato malo 25 min ago
11
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.
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.
As Covid cases, hospitalizations, and now deaths soar in Israel even though over 90 percent of older adults are fully vaccinated, the country is aggressively pushing a third shot.
Hundreds of thousands of older Israelis have already received it.
And other countries are preparing to follow.
Now the inevitable is happening. The third shot is beginning to fail. ...
The desperate move for a third shot is the latest and maybe most desperate manifestation of the panic around the vaccine failure that health authorities still will not openly admit is happening.
And it is profoundly anti-science.
These mRNA vaccines are not Pepto-Bismol. They have profound biological effects. They are encapsulated in fat particles whose long-term effects are unknown. They spread throughout the body (despite the early promise they would not). They hijack cellular machinery in exactly the same way an actual virus does.
They are no joke. ...
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