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This episode opinions a beforehand hidden report by Pfizer to the FDA overlaying the primary 90 days of ‘submit authorization’ vaccine security knowledge. A decide ordered its launch and, maybe not surprisingly, no main information outlet has dared to cowl the story.
Inside that first 90- day window, over 1,200 deaths have been reported, with a major quantity showing to occur inside the first 24 hours after vaccination. We are able to’t say for positive as a result of the report lacks vital particulars that may permit us to align the particular deaths with the reported remark that the median elapsed time between vaccination and the hostile occasion was “lower than 24 hours” for a lot of forms of AEs.
This report is a ‘second go’ by Pfizer after the primary report was deemed wholly inadequate and missing element. This one isn’t really all that significantly better, as it’s totally passive (no energetic knowledge assortment undertaken – it depends totally on “spontaneously” reported occasions, and no inquiry into the hostile occasions is a part of this model of the report), there’s no try made to outline the incidence of occasions, and there’s no seen effort made to match the degrees of occasions to an anticipated baseline of such occasions.
It’s also unattainable to find out first vs second vaccination injections (not reported) and the age brackets will not be even age brackets (“baby, grownup and aged”).
Apart from the 1,223 spontaneously reported deaths, there may be an awesome tilt in direction of ladies reporting AE’s usually on the order of 4x or extra. None of those have been deemed to be worthy of modifying both the administration of the vaccines or the gathering of latest knowledge in additional helpful element.
Additional, I monitor down the precise state of information of what’s and isn’t recognized about being pregnant and the vaccines to uncover the truth that no suppliers can say, come what may, if the vaccines are secure.
In essentially the most present language accessible to vaccine and well being care suppliers, Pfizer says “Out there knowledge on COMIRNATY administered to pregnant ladies are inadequate to tell vaccine-associated dangers in being pregnant.”
Naturally, with out having the ability to articulate the precise danger, true knowledgeable consent isn’t doable for pregnant ladies searching for to grasp what the dangers could be to their unborn baby. All that may in truth be mentioned is “we don’t know.”
If extra strong knowledge does exist, it’s not but been made public. We might have to attend as much as 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
Mattias Desmet interview
AMA – Knowledgeable Consent
https://www.ama-assn.org/delivering-care/ethics/informed-consent
Knowledgeable Consent – Pfizer Proivder Labelling (Being pregnant)
https://labeling.pfizer.com/ShowLabeling.aspx?id=15623&format=pdf
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Episode 038
00:00 – Intro
02:17 – Pfizer Security Information “Leaked”
09:38 – Identified Limitations of SAEs
12:59 – Points Instantly Obvious in Desk 1
21:32 – Security: Preganancy
24:08 – Kids – Off Label Use
27:09 – Coronary heart Points (Identified by Feb 28, 2021)
31:15 – Immune-Mediated
33:34 – Knowledgeable Consent
40:44 – What’s “knowledgeable Consent” for Being pregnant?
43:00 – Conclusions
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