I understand site 4444 was a 'virtual' site associated with 1231.
Pfizer documents confirm such sites existed.
The total number of Argentinian in the Safety Population is 5764 (only a few less than the total recruited at 1231 and 4444.
That aside the design of the study probably made it inevitable to get the result they wanted.
Beyond that, they have skewed the results to ensure the fabled 95% by misreporting AEs and other methods.
Thata Pfizer knew that it would only require "a target of 164 primary endpoint cases of confirmed covid19 occurring at least 7 days following the second dose... Will be sufficient to provide 90% power to conclude true VE greater than 30%" suggests to me they had set a low bar and worked backwards to get there by sifting data as necessary.
For instance the addv file confirms 1505 Protocol Deviations where "Potential covid 19 illness visit not done when required by protocol". 807 in the BNT drug arm.
Or that 311 drug arm participants were excluded from the efficacy endpoint due to "Important Protocol Deviations"
Both numbers utterly dwarfing the tiny number of 'confirmed covid cases" upon which the purported 95% efficacy was based.
The fact that the drug's real world implementation clearly shows the 95% is phoney doesn't seem to interest MSM. It is very strange.
Thanks
A great summary.
I understand site 4444 was a 'virtual' site associated with 1231.
Pfizer documents confirm such sites existed.
The total number of Argentinian in the Safety Population is 5764 (only a few less than the total recruited at 1231 and 4444.
That aside the design of the study probably made it inevitable to get the result they wanted.
Beyond that, they have skewed the results to ensure the fabled 95% by misreporting AEs and other methods.
Thata Pfizer knew that it would only require "a target of 164 primary endpoint cases of confirmed covid19 occurring at least 7 days following the second dose... Will be sufficient to provide 90% power to conclude true VE greater than 30%" suggests to me they had set a low bar and worked backwards to get there by sifting data as necessary.
For instance the addv file confirms 1505 Protocol Deviations where "Potential covid 19 illness visit not done when required by protocol". 807 in the BNT drug arm.
Or that 311 drug arm participants were excluded from the efficacy endpoint due to "Important Protocol Deviations"
Both numbers utterly dwarfing the tiny number of 'confirmed covid cases" upon which the purported 95% efficacy was based.
The fact that the drug's real world implementation clearly shows the 95% is phoney doesn't seem to interest MSM. It is very strange.
I will make updates later. Took today off.