PP: This episode reviews a previously hidden report by Pfizer to the FDA covering the first 90 days of ‘post authorization’ vaccine safety data. A judge ordered its release and, perhaps not surprisingly, no major news outlet has dared to cover the story.
Within that first 90- day window, over 1,200 deaths were reported, with a significant number appearing to happen within the first 24 hours after vaccination. We can’t say for sure because the report lacks critical details that would allow us to align the specific deaths with the reported observation that the median elapsed time between vaccination and the adverse event was “less than 24 hours” for many types of AEs.
This report is a ‘second go’ by Pfizer after the first report was deemed wholly insufficient and lacking detail. This one isn’t actually all that much better, as it is entirely passive (no active data collection undertaken – it relies entirely on “spontaneously” reported events, and no inquiry into the adverse events is part of this version of the report), there’s no attempt made to define the incidence of events, and there is no visible effort made to compare the levels of events to an expected baseline of such events.
It is also impossible to determine first vs second vaccination injections (not reported) and the age brackets are not even age brackets (“child, adult and elderly”).
Besides the 1,223 spontaneously reported deaths, there is an overwhelming tilt towards women reporting AE’s often on the order of 4x or more. None of these were deemed to be worthy of modifying either the administration of the vaccines or the collection of new data in more useful detail.
Further, I track down the actual state of knowledge of what is and is not known about pregnancy and the vaccines to uncover the fact that no providers can say, one way or the other, if the vaccines are safe.
In the most current language available to vaccine and health care providers, Pfizer says “Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
Naturally, without being able to articulate the actual risk, true informed consent is not possible for pregnant women seeking to understand what the risks might be to their unborn child. All that can truthfully be said is “we don’t know.”
If more robust data does exist, it is not yet been made public. We may have to wait up to 55 years for that.
Report title: 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
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