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.
The smoking gun is the November 9, 2020 article in "StatNews" in which a Pfizer executive flat-out admits that they halted processing of their clinical trial samples from late October 2020 until the day after the election:
StatNews offers a timeline of the announcement of its effectiveness:
"The story of how the data have been analyzed seems to include no small amount of drama…. In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study."
In other words, the companies skipped both the first (32 cases) and second (62 cases) scheduled interim analyses and only did the third (92 cases). But then it turned out that the vaccine was so effective (over 90 percent) that the first 32-case analysis likely would have been sufficient after all.
"Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage."
That’s pretty wild: The firms had their labs stop processing cases and just put the samples in cold storage. They stopped the count. They ran out the election clock.
"The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday."
Perhaps coincidentally (or perhaps not), last Wednesday was the day after the election. As one cynic suggested: They didn’t choose a sample size for when to report, they chose a date.
So, it appears that Monday’s announcement perhaps could have been made before the election. But the corporations weren’t in the mood to follow their own protocol and Trump’s FDA let them get away with stalling on telling voters and investors what had been achieved.
From a political and financial standpoint, the firms likely made the self-interested right decision to delay. Even giant pharmaceutical companies don’t want to wind up on blacklists for vengeance by Democrats. But from a scientific and ethical perspective, it was highly questionable.
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.
The smoking gun is the November 9, 2020 article in "StatNews" in which a Pfizer executive flat-out admits that they halted processing of their clinical trial samples from late October 2020 until the day after the election:
StatNews offers a timeline of the announcement of its effectiveness:
"The story of how the data have been analyzed seems to include no small amount of drama…. In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study."
In other words, the companies skipped both the first (32 cases) and second (62 cases) scheduled interim analyses and only did the third (92 cases). But then it turned out that the vaccine was so effective (over 90 percent) that the first 32-case analysis likely would have been sufficient after all.
"Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage."
That’s pretty wild: The firms had their labs stop processing cases and just put the samples in cold storage. They stopped the count. They ran out the election clock.
"The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday."
Perhaps coincidentally (or perhaps not), last Wednesday was the day after the election. As one cynic suggested: They didn’t choose a sample size for when to report, they chose a date.
So, it appears that Monday’s announcement perhaps could have been made before the election. But the corporations weren’t in the mood to follow their own protocol and Trump’s FDA let them get away with stalling on telling voters and investors what had been achieved.
From a political and financial standpoint, the firms likely made the self-interested right decision to delay. Even giant pharmaceutical companies don’t want to wind up on blacklists for vengeance by Democrats. But from a scientific and ethical perspective, it was highly questionable.
https://www.takimag.com/article/the-new-normal-by-any-means-necessary/
"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/