5 ms·

How did the FDA even review 450,000 pages for EUA in the first place?

by tintor 5y ago

defaultprimate 5y ago
Pfizer financed an accelerated reading program for them
- encryptluks2 5y ago
  Haha. Sure, I'll read for 160 hours in a day of you pay me enough. Just don't give me any quizzes.
  - defaultprimate 5y ago
    The program was named after Hooked on Phonics, but it was called Hooked on Pfizer, and they mostly looked over numbers and dollar signs.
lalaland1125 5y ago
The FDA generally would only review the summaries, not the full patient information. 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.
- bryanlarsen 5y ago
  Hopefully they also statistically validly sampled the full patient information.
albatross13 5y ago
Pessimist opinion? They didn't. The FDA has people move to private enterprise (https://www.cnbc.com/2019/06/27/former-fda-commissioner-scott-gottlieb-joins-pfizers-board.html https://www.cnbc.com/2019/06/27/former-fda-commissioner-scot...) and vise versa (I don't have sources, but I would be shocked if it didn't happen). 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.
- rajin444 5y ago
  It was more or less common knowledge “big pharma” doesn’t have a strong record when it comes to trust before Covid. It’s pretty crazy how fast political tribalism can be used to change people’s minds. Just because your political enemy wants to do something does not mean it’s bad. 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.
  - albatross13 5y ago
    > These vaccines were an amazing tool to help end the pandemic Oh, it has ended? lol.
    - lalaland1125 5y ago
      It has pretty much ended for the vaccinated. Vaccinated people have a very very low chance of death or hospitalization, an order of magnitude lower than the unvaccinated in many cases.
      - Handytinge 5y ago
        There are many countries where lockdown, daily restrictions, entry requirements and isolation are still normal. This pandemic is global - just because things have improved where you are doesn't mean that's the case for the other 95% of the world's population.
        lalaland1125 5y ago
        That's a non-sequitur. The pandemic, as in the actual killing / harming of people with the virus, is mostly over for vaccinated people. 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.

How did the FDA even review 450,000 pages for EUA in the first place?

by tintor 5y ago

How did the FDA even review 450,000 pages for EUA in the first place?

defaultprimate 5y ago

Pfizer financed an accelerated reading program for them

encryptluks2 5y ago
Haha. Sure, I'll read for 160 hours in a day of you pay me enough. Just don't give me any quizzes.
- defaultprimate 5y ago
  The program was named after Hooked on Phonics, but it was called Hooked on Pfizer, and they mostly looked over numbers and dollar signs.

lalaland1125 5y ago

The FDA generally would only review the summaries, not the full patient information. 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.

bryanlarsen 5y ago
Hopefully they also statistically validly sampled the full patient information.

albatross13 5y ago

Pessimist opinion? They didn't. The FDA has people move to private enterprise (https://www.cnbc.com/2019/06/27/former-fda-commissioner-scott-gottlieb-joins-pfizers-board.html https://www.cnbc.com/2019/06/27/former-fda-commissioner-scot...) and vise versa (I don't have sources, but I would be shocked if it didn't happen). 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.

rajin444 5y ago
It was more or less common knowledge “big pharma” doesn’t have a strong record when it comes to trust before Covid. It’s pretty crazy how fast political tribalism can be used to change people’s minds. Just because your political enemy wants to do something does not mean it’s bad. 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.
- albatross13 5y ago
  > These vaccines were an amazing tool to help end the pandemic Oh, it has ended? lol.
  - lalaland1125 5y ago
    It has pretty much ended for the vaccinated. Vaccinated people have a very very low chance of death or hospitalization, an order of magnitude lower than the unvaccinated in many cases.
    - Handytinge 5y ago
      There are many countries where lockdown, daily restrictions, entry requirements and isolation are still normal. This pandemic is global - just because things have improved where you are doesn't mean that's the case for the other 95% of the world's population.
      - lalaland1125 5y ago
        That's a non-sequitur. The pandemic, as in the actual killing / harming of people with the virus, is mostly over for vaccinated people. 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.