How did the FDA even review 450,000 pages for EUA in the first place?
A lot of those 450,000 pages are careful patient documentation that simply isn't necessary when you already have the total side effect counts.
At most the FDA might review the clinical history of the patients with severe side effects. They aren't going to be reading the notes about every Bob Smith reporting fatigue after getting a COVID-19 vaccine.
To that end, my (pessimist) opinion is that there were likely some financial incentives for the FDA to uh...gloss over 60% of that 450,000.
These vaccines were an amazing tool to help end the pandemic but the producers who are profiting heavily from these should be scrutinized as much as possible given there are hundreds of millions receiving this vaccine.
Oh, it has ended? lol.
True, some political response to the pandemic are still in place, but that would happen no matter what as politics tends to move slower than the reality on the ground.
... That's not the definition of pandemic. A pandemic is a very widespread infectious disease. Theoretically, the disease doesn't even have to be deadly.
It's true that the vaccines have substantially reduced risk for the vaccinated, but I don't think we can (yet) say the pandemic is over.
Omicron puts us in the endgame--Covid is an endemic disease now. It's not the endgame we wanted, but it's the endgame.
Omicron is apparently as contagious as chicken pox, and chicken pox effectively infected every person (generally in waves when enough new children hadn't had it). Due to Omicron, in 30-60 days, everyone will have been infected, vaccinated, or both.
Even if you could get all the human infections to zero, the animal reservoirs would simply start it up again.
Welcome to the new world. Perhaps people will take a pandemic slightly more seriously next time. But I doubt it.
Companies can't fake the data because if they got caught, there would be long jail terms and billions of dollars of fines (and they provide too much data for it to be easily forgable).
Have you haerd of Exxon?
The Sacklers held on for 20 years on Oxycontin…
Also, I don't think that the manufacturer of Oxycontin has tricked the authorization process (and then successfully covered up this fact for 20 years). As far as I know, the problem was their marketing strategy, how they convinced doctors (medical practitioners) and probably patients (I can remember the details). So while it's troubling, it's a completely unrelated process and thus unrelated issue.
It proves that the FDA shouldn't use a "trust, and don't verify" approach to medical trials performed by megacorporations.
Also, no one said "trust and don't verify". What was said is that they don't have to verify all the data and read through all the pages. Because the risk is just too high and they will obviously look into the details here and there.
https://violationtracker.goodjobsfirst.org/parent/pfizer
These dudes literally bake "billions in fines" into their operating model, and who cares when their latest and greatest customer puts a gun to everyone's head and says "take pfizer product or lose your livelihood". Billions in fines mean nothing when the federal government guarantees you 15x that in revenue a year.