1. "Operation Warp Speed" or how to develop'n produce vaccine in 14 months instead of 73.
With 14 months timeline ending on 1/1/2021🧐🗓️
We should probably read april, but that's a detail…
media.defense.gov/2020/Aug/13/20…
2. 12-month FDA review is replaced by a continuous control of safety and efficacy data.
It really must have been a tremendous work to inspect hundreds of trial sites and dozens of manufacturing units…
3. But this @USGAO report tells us that only 58 #FDA biological inspections were conducted from April 2020 to March 2021, up from 1,500 in the previous 12 months. <30 before December.
files.gao.gov/reports/GAO-22…
4. Among these inspections, we find, for the 33 Covid vaccine sites: 2 Moderna sites, 2 Janssen, 1 Novavax, 1 GSK.
None for Pfizer after mid-2019.
Completed by 7 EUA investigations and 2 site visits.
Amply sufficient, right?
5. But guess who's the designer of Operation Warp Speed?
Dr Peter Marks, top vaccine regulator for FDA.
Responsible for safety and… on-time delivery, with help from Pentagon. Quite the job!
nytimes.com/2020/11/21/us/…
6. Because, for #Trump, the priority is to announce the vaccine before November election.
It will be missed by a few days🤏🏼
#Bourla and #Bancel probably had nothing to gain from having their results acclaimed by a campaigning president.
A little discretion couldn't hurt.🐾
7. The @nytimes paper also describes how Pfizer broke away from standard testing rules by consulting the data too early and too often.
8. So when @USGAO's report shows a heartbreakingly reduced level of control, shouldn't we consider that #FDA just acted as an auxiliary of #Pfizer & #Moderna, with no right to failure, seemingly.
9. Is the #Ventavia affair revealed by the #BMJ only a rotten apple in a big basket or a patch that drops on the wall of a toxic sludge tank?
And this only concerns clinical trials, not vaccine production conditions🧐 bmj.com/content/375/bm…
10. As for the 9 RCT inspections quoted by the BMJ investigation, if someone manages to find them in the #FDA base, they are really well hidden. I could not.
datadashboard.fda.gov/ora/cd/inspect…
Please note, the @nytimes article is not open access.
You can try it out via the @waybackmachine :
web.archive.org/web/2020112512…
Thanks for Retweets!🙏🏼
🇫🇷Threads originaux disponibles en français :
New development (in french)
Share this Scrolly Tale with your friends.
A Scrolly Tale is a new way to read Twitter threads with a more visually immersive experience.
Discover more beautiful Scrolly Tales like this.