Pressuring the FDA

With reports of the delta variant of COVID surging, the Biden inner circle has grown impatient with the Food and Drug Administration.  It wants the FDA put on a wartime footing so as to get formal approval as quickly as possible for the three COVID vaccines currently on the market.  This is vital for the vaccination effort.  A recent poll by the Kaiser Family Foundation found that three out of ten people who have yet to be vaccinated said they would get vaccinated if the vaccines were so approved.  The thinking is that formal FDA approval would convince more people to take the jab than things like the $100 incentive that's now being offered in some places.

A wartime footing does not merely mean that FDA employees working longer hours and postponing vacations, although that is probably happening.  The wartime footing Biden wants is a call for the agency to shortcut its normal approval procedures in order to put its stamp of approval on these novel COVID vaccines.

There is no doubt that government bureaucracies can be hidebound and wasteful in terms of both money and time.  The FDA is no exception.  But the tremendous pressure now being put on those inside the FDA could be dangerous.  Here I agree with Sundance when he writes: "FDA approval [of the vaccines] is a foregone conclusion, regardless of [their] safety or efficacy."  It's easy to see why.  Already 165 million Americans plus hundreds of millions more worldwide have already been given these vaccines.  Quoting Sundance again:

The FDA, just like a vaccinated person, is in a no retreat position. There is no way the U.S. FDA cannot approve the vaccines that have been sold, forced, and pushed on the entire global population. Can you even begin to imagine the ramifications of the FDA saying the vaccine was (a) unsafe; or (b) ineffective? 

This analysis rings true.  If it's correct, we can expect to see the FDA soon approving the COVID vaccines.  The vaccination effort needs this approval to get more people vaccinated and to justify what has already happened.  When the approvals are announced, expect the media to tout them to the sky.  According to the Kaiser poll cited above, 30% of the unvaccinated will find the approvals convincing.  For others, it will cut their legs out from under them when resisting the entreaties from their employers, doctors, and family and friends to get vaccinated.  Then only the hardcore anti–COVID vaxxers will be left for the government to deal with. 

But the fundamental question still remains.  Are these vaccines actually safe?  Will the FDA have legitimately determined that there are no serious long-terms adverse side effects?  And will it have been shown scientifically that these vaccines are 90%-plus effective as advertised?  All that's a possibility.  But seeing how Washington works and the spot the FDA is in, count me skeptical.  I would no more trust the FDA in this matter than I would media reports of a "fair" election where only Democrats counted the ballots.

Image: FDA.

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