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Why Did Pfizer And FDA Agree To Not Release The News Of The Vaccine's Success In October As The Original Protocol Would Have Required?
The evidence that this pandemic, from the AFT pressuring the CDC to keep schools closed in February to this intentional delay by Pfizer, was politicized, is overwhelming. Science took a backseat to politics.
The evidence that this pandemic, from the AFT pressuring the CDC to keep schools closed in February to this intentional delay by Pfizer, was politicized, is overwhelming. Science took a backseat to politics.
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. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
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. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday.
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. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday.
So the original plan was to make a public announcement after 32 cases, but instead they stopped doing simple lab tests until the day after Election Day, at which point they had 94 cases, almost triple what the protocol had said they needed for making a public announcement.
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