FDA Career Staff Are Delaying the Vaccine as Thousands of Americans Die | Hacker News Reader

FDA Career Staff Are Delaying the Vaccine as Thousands of Americans Die

thedispatch.com

8 pointsamadeuspagel8 comments

> FDA insiders say the agency and its approximately 17,000 employees were dark for the four-day Thanksgiving holiday, including those working on the vaccine approval.

At 2000 people dying each day, that's a pretty expensive vaca.

> Back in January, The Dispatch reported on the shocking story of how FDA regulators told University of Washington physician Dr. Alex Greninger that he could not test suspected COVID patients in Washington state, requiring him to first apply for an FDA authorization to do so. The complicated application Greninger completed sat at the FDA until he inquired about the delay. He was told that his electronically submitted application was incomplete because he had to also print it out and mail a physical copy along with a CD-ROM or hard drive of the electronic application. You can’t make this stuff up.

A four-day weekend off for Thanksgiving won't make much difference when it's going to take months to scale up manufacturing no matter what.

But needing to mail in a CD along with your printed application is hilariously bad.

I dont get this logic. If it is going to take months to scale up manufacturing then we can just add a few more days and take another 2,000 deaths per day? How many few more days are acceptable?

I think the logic is that the scaling up manufacturing is already occurring in parallel, so it isn’t as simple as an N day delay causing N days worth of deaths.

The excess deaths would be N times the (small) fraction of daily deaths that would be prevented by the initial (small) use of vaccines.

I don’t know how true this is because I don’t know what the situation is with vaccine stockpiles, which could change the analysis.

Exactly. I bet the Gantt chart for this is pretty big and complicated, with lots of work by multiple groups going on simultaneously. I bet the work started a year ago, doing things like deciding which other manufacturing activities they would halt or slow if they had a viable vaccine, or if they would open new manufacturing facilities.

I just hope that they didn't waste too much time making Gantt charts.

Not to mention quietly sitting on the electronic submission because it was missing the CD, without notifying the sender of the missing requirement.

My company is full of these kinds of slackers. They always seem to be ready with some feeble excuse like this for why something isn't being worked on. They're not fooling anyone.

Yes, that's the cherry on top. They were clearly much too busy ignoring incomplete applications to send that email.

More on this subject from Tyler Cowen: https://marginalrevolution.com/marginalrevolution/2020/12/ho....

Apparently the FDA could review clinical data and make a call on the vaccine in 24-48 hours, without cutting any corners.

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