The application and data was submitted 3 weeks ago... it took 3 weeks for the FDA to drag their feet and just say the obvious...
It is like the titanic is burning and these guys are playing violin...
It is like the titanic is burning and these guys are playing violin...
There was no decision that shouldn’t have been made ahead of time. Either it met the predefined criteria or it didn’t.
Everything else should have been a continuous process of pre-verification up to the point the 128 positive confirmed COVID cases were unblinded.
Assume the unblinded results will be good enough, and verify everything else you would normally verify ahead of time. The only thing that remains is to verify the unblinded cases the day they are announced.
And not just that but your approval thresholds should already be preset and preregistered, the doses already distributed to point-of-care, and nurses start administering shots the very next day.
Yes it’s a big waste of money if it turns out not to work. That’s the whole point.
Turns out the vaccine is highly effective 10 days after the first dose. We could have been doing at least a million doses a day since November 19th. Realistically even long before then.
Remember when the FDA wouldn’t let public or private labs run their own COVID tests and everything was being shipped to CDC headquarters to PCR?
The CDC and the FDA essentially guaranteed through extraordinary ineptitude that the US would not fend off COVID back in January/February. They deserve zero benefit of the doubt.
The FDA’s 70 years of process likely worked against them here. What I can say for certain is that there was a t-minus one, the day before the results were unblinded, and there was a t-zero, the day results were unblinded. On that day t-zero they uncovered which of the patient IDs got the vaccine versus which got placebo.
No expense should have been spared in preloading the analysis, verification, whatever could have been done, it should have been done up until t-minus-1. On day t-zero you get 15,000 patient IDs in column A and 15,000 in column B, that’s the only new thing you learn that day. There should be nothing new to talk about or discuss, the approval criteria should already be set in stone. Check the IDs and launch.
They shut down testing back when we needed it most, allowing us to pretend there was no spread in the US for far too long: https://www.statnews.com/2020/05/27/coronavirus-testing-seat...
They spent far too long before approving any kind of at-home testing and to this day have not approved most rapid testing.
Three weeks ago the EUA was submitted, so three weeks ago there was an entire team of people at pfizer who had reviewed all the data and were confident FDA would approve the application, but somehow nobody at FDA was part of that set of people. In any reasonable process that application would have contained no new information, if it contained any new information they were not communicating closely enough.
I understand spending a few days doing some final checks on the data before approving. Three weeks, however, is suspiciously long. It's possible they were in fact doing important work which could not possibly have been done before the application was submitted, but nobody seems able to articulate what that important work actually was.
I love HN who is normally vehemently anti-business (with good reason) suddenly flips and says “well Pfizer said the vaccine was ok, isn’t that good enough?”
No. It’s not good enough. The reason we spend billions per year on the FDA is because we want an independent, critical and evidence based body making decisions on drugs given to hundreds of millions of Americans.
I mean, hell, Trump was bullying the FDA (which was stupid) and HN seems to be arguing for that exact thing.
Nowhere in my comment did I say the FDA should just take Pfizer's word for anything.
I'm also not sure why you're trying to use Trump's actions as evidence here. "Trump did a thing and therefore doing that thing was the correct action" is an argument which requires some justification.
Highly doubtful. Pushing out an unsafe vaccine would be disastrous to Pfizer. They have every incentive in the world to be as absolutely certain as possible that the data is solid.
And so is the argument that Pfizer would have any incentive to fudge the data.
How is it you think the UK was able to approve it already???
https://marginalrevolution.com/marginalrevolution/2020/12/ho...
EDIT: Multiple downvotes already. Anyone care to refute what's presented in my post? Did you read any of the sources cited in the linked blogpost?
Are Gov jobs granted overtime work by ruling party, and how was this important work prioritized and coordinated by top leader?