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Thank you for this extremely valuable chapter. Redefining the term "vaccine" allowed this modRNA-LNP treatment to be evaluated by the Vaccine committee of the FDA instead of the Biological Treatment committee. It shortened the time line allowing use of the EUA approval mechanism.
Determination of "efficacy" was allowed to be entirely dist…
Thank you for this extremely valuable chapter. Redefining the term "vaccine" allowed this modRNA-LNP treatment to be evaluated by the Vaccine committee of the FDA instead of the Biological Treatment committee. It shortened the time line allowing use of the EUA approval mechanism.
Determination of "efficacy" was allowed to be entirely distorted. FDA's own guidelines recommend using ARR not RRR. The calculation used by Pfizer was bizarre form of ARR. Moreover, their method of determining subjects infected with COVID19 was confusing combination of symptoms and RT-PCR testing at excessive cycle numbers. Most of the infamous "170" infected subjects came from the Argentina site which had been cited for problems. The FDA should never have accepted their data.
Safety data at the time of EUA approval was based on approximately 9,500 vaccinated subject who had been followed for 20 weeks. This "exposure" to treatment would only allow SAE signals for the most common classes of events. In fact, there were signals - heart attack, Sudden Adult Deaths, facial paralysis - whose significance was obscured by the methods used to report the data, especially the dates and numbers of vaccinated subjects.