Stop digging yourself a bigger hole, Mr President.
(finance.yahoo.com)
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Some of us have worked in regulated industries and know that if something that normally takes > 3 years to get an approval takes less than one year, there are a lot of people under the gun to simply hit a date and taking a lot of shortcuts to do so.
I can't even imagine the sort of stress the scientists and engineers who made the vaccines were under to get it out the door.
My understanding is that it took them two days to synthesize the "vax" once they had the code for the spike protein from the CCP.
There is a lot of work that goes into putting anything into mass production once you have something you think is ready to put into mass production, even if you completely ignore the regulatory aspect of things.
I would imagine that anyone on the team who raised too many concerns to anyone but the company higher-ups was quietly removed, and the ones who folllowed the 'appropriate channels' informed a room full of the company's executives, who then quizzed their lawyers and accountants to see how much money they could expect to be sued for/fined, and how much money they could expect to make.
"So we'll get fined a billion dollars 5 years from now, Who cares, we're gonna make 40 billion on this!"
Yes, because it's cost vs. benefits. You don't let the Coronavirus ravage through vulnerable populations for 3 more years because of stupid bureaucracy, and by the way, criticism of bureaucratic delays in approving medicine has been the right-wing position going back all the way to Ronald Reagan.
Ronald Reagan was a Hollywood scumfuck who pushed the National Childhood Vaccine Injury act which removed liability from vaccine manufacturers.
Fuck Reagan and his brand of "conservatism" which helped only companies and not people.
So now you're against polio, mumps, etc. vaccines as well?
I am against vaccine manufacturers being completely shielded from all liability which is the result of the NCVI act passed by Reagan.
Did I say I was against the polio, MMR vaccines? No I didn't.
If in fact the purpose of the accelerated timeline was to protect vulnerable populations, that limitation needed to go into the Emergency Use Authorization; and it ought to have been limited to people >= 65 years of age and people in other at-risk populations. Instead governments started mandating everyone with a pulse get injected or lose their ability to participate in society and feed their families. That intended use results in a much different risk profile and a much different cost/benefit analysis, which to the extent it was eventually done was performed in a heavily politicized environment.
Beyond that, when you so drastically and so quickly change the regulatory environment as was done, it's difficult for everyone to acclimate themselves to the new environment. They either under-correct and are still too conservative for the new environment, or they over-correct and neglect things that are still actually important to patient safety. Or they first under-correct and then over-correct once they realize that they're acting too conservatively to hit project deadlines.
That seems to be more the problem than even limiting usage to people aged >= 65. There is no reason to deny a 50-year-old the vaccine if he wants it, considering that there have been people that age who got it and got terribly sick from it.
What I don't understand is why we get mostly glowies here calling the vaccine "poison vax" because they don't like mandates. Which, for work, is almost exclusively an American thing. As far as I know, no other country has mandated it for non-health care workers.
If you're saying that people did not adjust to the facts and assume that approval means that vaccines are "safe and effective", as they keep endlessly repeating, then I agree.
But if it's a choice between alternatives, I'd still say that the emergency approval was a very good thing. Surely, you're not going to wait five years before approving a (probably by then obsolete with the new variants) vaccine when the virus is killing millions of people each year.
The speed at which the approvals came combined with the hyper-politicized environment in which the approvals occurred where the vaccine was going to be our salvation and the way out of shutting down the economy. I believe the FDA was under enough political pressure to approve the vaccines that there is no way they would have withheld approval.
That alone was enough to make me shy away from it. Beyond that I thought it was weird that a bunch of coworkers the same age as I mentioned feeling so unwell after the second injection they couldn't work for a couple days. That didn't seem like a very good deal either, given my personal risk profile.
I mean the FDA and the medical industry in general abhors haste and is not well-practiced at making quick decisions. That industry is like playing Chess, whereas the vaccine development and approval process was like playing Speed Chess. The skill-sets are different, and a Chess player may not be very good at playing Speed Chess if he's never done it before.
I don't care about big pharma: I care about the grunts working for big pharma who get called into a room with their boss's boss telling them the vaccine will be approved by the deadline, with or without them. And who realize that if they do something unsafe, the regulator they'd normally whistleblow to is under the exact same pressure to approve the thing once it crosses their desk.
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