Why didn’t we get Pfizer’s vaccine before the election? Why wasn’t the AstraZeneca vaccine approved in the US shortly after being approved in the UK? Why were there not any COVID-19 human challenge trials until 7 March 2021? To shed some light on these questions, I constructed this timeline. However, much further autopsy is needed on the decision making processes that occurred at the FDA to prevent the FDA’s
Thanks so much reading and for the corrections! I have fixed all of them.
I had no idea there was a link on the scroll emoji. The way they show up has been different in different browsers and I think may have changed recently due to an update on Substack's end.
You are missing one key event: According to Pfizer executive William Gruber's statement to StatNews' Matthew Herper on 11/9/20, Pfizer shut down processing of lab samples in its vaccine clinical trial from late October and only resumed on 11/3/20, perhaps not coincidentally the day after the election. So when Pfizer finally announced on 11/9 the results from 94 cases, it had blown past its first 3 published checkpoints at 32 cases, 62 cases, and 92 cases.
My guess is that if not for this extraordinary step by Pfizer to stop lab work on the world's most important clinical trial, it would have announced high efficacy based on 62 cases the day before the election.
Efficacy and safety are different issues, so the FDA might not have issued its emergency approval any earlier. But Trump's strategy of facilitating vaccine development would have been vindicated during the campaign. If that flipped 0.16% of the electorate from Biden to Trump, the Electoral College would have elected Trump to a second term.
Thanks for putting this together.
> 12 August 2020 🇵 The person delegated EUA authority for vaccines at the FDA, Dr. Peter Marks,
cut off?
> AstraZeneca has to halt their trial due to among a participant having neurological symptoms.
extra word?
> 13 September 2020 ... Bourla also announced announced Pfizer has almost 30,000 people enrolled in their Phase III trial
extra word
Also all the scroll emojis have a weird link which is probably unintentional.
Thanks so much reading and for the corrections! I have fixed all of them.
I had no idea there was a link on the scroll emoji. The way they show up has been different in different browsers and I think may have changed recently due to an update on Substack's end.
"Kalama Harris"
Kamala
Thanks. Very helpful.
You are missing one key event: According to Pfizer executive William Gruber's statement to StatNews' Matthew Herper on 11/9/20, Pfizer shut down processing of lab samples in its vaccine clinical trial from late October and only resumed on 11/3/20, perhaps not coincidentally the day after the election. So when Pfizer finally announced on 11/9 the results from 94 cases, it had blown past its first 3 published checkpoints at 32 cases, 62 cases, and 92 cases.
My guess is that if not for this extraordinary step by Pfizer to stop lab work on the world's most important clinical trial, it would have announced high efficacy based on 62 cases the day before the election.
Efficacy and safety are different issues, so the FDA might not have issued its emergency approval any earlier. But Trump's strategy of facilitating vaccine development would have been vindicated during the campaign. If that flipped 0.16% of the electorate from Biden to Trump, the Electoral College would have elected Trump to a second term.
For documentation, see:
https://www.takimag.com/article/the-new-normal-by-any-means-necessary/