BOMBSHELL:
The TGA originally allocated #comiRNAty #pregnancy category B2 (unknown risk) in their assessment of the product, prior to ACV committee review.
They downgraded this risk to B1 by suppressing a documented finding of the preclinical data
tga.gov.au
The TGA originally allocated #comiRNAty #pregnancy category B2 (unknown risk) in their assessment of the product, prior to ACV committee review.
They downgraded this risk to B1 by suppressing a documented finding of the preclinical data
tga.gov.au
For reference:
Category B2 is effectively "suitable animal studies haven't been performed, risks are unknown"
Category B1 is "animal studies have been performed which haven't shown risks"
It's a huge difference.
tga.gov.au
Category B2 is effectively "suitable animal studies haven't been performed, risks are unknown"
Category B1 is "animal studies have been performed which haven't shown risks"
It's a huge difference.
tga.gov.au
The wording was changed between one version of the evaluation document and the next, and the abnormalities seen in the ONE tiny animal study (only 22 rats with limited evaluation of the offspring) were suppressed.
Bingo! B2->B1
Bingo! B2->B1
In fact it looks like TGA told the drug company to downgrade the pregnancy and fertility statements on their novel product.
Why?
Who is the "Module 4 evaluator"?
tga.gov.au
Why?
Who is the "Module 4 evaluator"?
tga.gov.au
Worse, the pre-implantation loss rate in the treated group was double that of the control group and not only was this information ignored but no request was made to evaluate further.
Yet the TGA still downgraded to category B1
tga.gov.au
Yet the TGA still downgraded to category B1
tga.gov.au
Is there an increased risk of miscarriage after #covid19 vaccination? This article debunks some of the myths and misinformation and explains why the #vsafe data should have been investigated further.
Why is the V-safe data not openly available?
arkmedic.substack.com
Why is the V-safe data not openly available?
arkmedic.substack.com
If it turns out that the TGA took an unprecedented risk in their evaluation, especially if they were unduly influenced to do so, this will be a massive scandal and likely result in a huge class action.
If that happens, the TGA will need to explain why they used all their resources to suppress the release of the animal "studies" (actually only one study) when requested under FOI 2289.
There is clearly more to this story.
constitutionwatch.com.au
There is clearly more to this story.
constitutionwatch.com.au
I suspect this poll is even more appropriate in this context...
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