Videos: How Pfizer’s EUA Was Granted Based on Fewer Than 0.4% of Clinical Trial Participants
The videos linked below offer audio-visual explanations of Report 42: Pfizer’s EUA Granted Based on Fewer Than 0.4% of Clinical Trial Participants. FDA Ignored Disqualifying Protocol Deviations to Grant EUA.
These videos show:
1. The pivotal Pfizer trial upon which the Emergency Use Authorization (EUA) for the COVID -19 vaccines was on the endpoint of efficacy of the vaccines.
2. This was to be done when the number of eligible patients (“evaluable efficacy population”) reached a threshold for analysis. The threshold was 164 trial participants.
3. We show that this threshold was likely not met and that the granting of the EUA should revisited.
4. There seemed to be a deliberate ambiguity left in the trial protocol documents to allow patients who would otherwise be deemed to have violated the trial protocol to still be included in the analysis. There was marked difference in what was implicitly stated to be the appropriate dosing interval between Dose 1 and Dose 2 in the trial protocol and all subsequent 14 protocol amendments, and what was accepted and approved in the EUA memorandum in December 2020.
3. We show that this threshold was likely not met and that the granting of the EUA should revisited.
4. There seemed to be a deliberate ambiguity left in the trial protocol documents to allow patients who would otherwise be deemed to have violated the trial protocol to still be included in the analysis. There was marked difference in what was implicitly stated to be the appropriate dosing interval between Dose 1 and Dose 2 in the trial protocol and all subsequent 14 protocol amendments, and what was accepted and approved in the EUA memorandum in December 2020.
5. We also show that patients in the final efficacy analysis had other significant protocol deviations, besides just going outside of the protocol’s dosing interval.
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Short “explainer” video:
Longer “explainer” video narrated by report author, Jeyanthi Kunadhasan, MD, FANZCA:
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Missing a word for clarity (should be revisited)
3. We show that this threshold was likely not met and that the granting of the EUA should revisited.