In making that argument, Pfizer cited WHO guidance written in 2002 by a team led by Marion Gruber.
I am bothering RFK Jr and Mary H re this post and suing Gruber
Yes the lipid nano-particulates were/are synthetic and toxic but so was/are the mRNA payloads.
As admitted by UK MHRA in email exchange with me in December 2020:
Sounds like they were just "fast tracking" the product, and maybe had a good "vaccine regulation consultant"
(May as well detonate your stack as well as mine today!)
----Dr. Malone has a history of assembling and managing expert teams that focus on solving complicated biodefense challenges to meet US Government requirements. He was instrumental in enabling the PHAC/rVSV ZEBOV (“Merck Ebola”) vaccine to move forward quickly towards BLA and (now recently granted) licensure. Dr. Malone got the project on track in support of DoD/DTRA and NewLink Genetics, recruited organizations to team with USAMRIID/WRAIR to develop the immunoassays, put WHO and Norwegian government philanthropic leadership in touch with Pentagon leadership to expedite the initial WRAIR clinical and ring vaccination trials, recruited a management team, recruited Merck vaccines to purchase the product candidate from NewLink, helped write and edit the clinical trials developed by the World Health Organization and lead the development of the BARDA and DTRA contracts - yielding over 200M$ in resources. Dr. Malone’s early involvement in this project allowed for the Merck vaccine to be developed very rapidly.
You must have one of the finest legal minds on the planet. Thank you for all your work.
very easy to say your own work needs no revision isn't it? These people just have no shame ! I hope you and others are able to get these people to come to trial, but probably they will end up like so many nazi's among which Dr Mengele, who escaped the trials. There is a special place in hell for people like that.
well, I must say, this is a very different take on Gruber than I've heard elsewhere. I had thought Gruber resigned from her FDA position about a year ago because the White House basically went over her head, approving boosters without strong evidence of effectiveness. so, in a way, her resignation was viewed by some (e.g. Vinay Prasad) as a brave public push back against a meddling, anti-science, industry captured, presidential administration.
You are doing such important work, Katherine. I think that putting our talents to the most useful purpose in this moment is so critical, and we all have such different ones (which is a blessing, since the beast has so many faces and heads). Thank you and God bless you.
Marion F. Gruber can still argue she has openly stated the EUA was based on a belief. The biggest problem is that almost no one has read what she has written.
This is a must watch
gruber and her predecessors have a long and sordid history of rubberstamping stuff they shouldn't have rubberstamped. was this just gruber being gruber, like cheney sending the planes into the towers knowing that silverstein would blow them up the second he could collect the insurance money? or was there someone off camera directing her to sign off on the kill shot?
To be fair:
Pfizer did not permit any honest investigation of their "work". They took immediate political control of individual countries by blackmail.
Pfizer must have some powerful friends among the 300, huh...🤔.
In Regulatory parlance, it is the INDICATION or USE of the drug which determines the regulatory assessment path. If the USE is for prevention of an infectious disease it will go through the vaccine BLA procedure. Kind of a "get out of jail free" card. That is because all the clinical trials etc is for prevention of an infectious disease. So measures of vaccine effectiveness is used.
However, that does not negate the fact that this product is a genetic product, and as such should have been assessed for safety and toxicity as any genetic therapy normally would. In fact, Sahin, the head of BioNTech actually though a vaccine product would be assessed as gene therapy. This would entail risks of autoimmune disease, neurological disease and risk of cancer.
https://www.nature.com/articles/nrd4278 (see box3)
Drug manufacturers, use the FDAs own regulatory procedures against them to their own benefit. They argue about how previous assessments were done, how there is a precedent, yada, yada. It is what one would call a Process. Sometimes, but not often, the FDA uses the process to their benefit as well. A regulatory dance, if you will. Looks like Pfizer and Moderna won this round handily.
I can't thank you enough for all the work you are doing. May this work be rewarded through prevention of anything remotely like this happening to any living population. And my all those responsible, be held accountable to the highest standards of the law. No cake walk.
mRNA vaxxes are INHERENTL:Y toxic, and would be even if the foreign protein they code for is non-toxic.
Killer T cells function to attack and kill cells expressing foreign proteins; that's how they help to slow or stop the spread of cancers and viral infections.
mRNA vaxxes cause your cells to express foreign proteins.
Ergo, mRNA vaxxes can promote autoimmune attacks on any tissues that take them up.
In rodent studies, heart tissue has a high propensity to incorporate the mRNA. That's why we are seeing so much myocarditis.
Of course, with these particular mRNA vaxxes, the protein they code for is extremely toxic; but that wasn't immediately obvious. The risk for autoimmunity WAS.
The "scientists" who developed mRNA vaxxes are either idiots or willingly turned off their brains to keep their employment.
The logic I have just recited should be glaringly obvious to anyone with the most basic understanding of immunology.
Katherine, I've been reviewing your posts and documents for the past 2-3 weeks in earnest. I have also been reading and listening to the interviews you and Sasha L. have done. I am currently writing up a "form letter" to send to public and elected officials.
We have a group here in Idaho that will be pushing for legislative action. I pray that we can find some good souls that will honestly look at the information and work with us.
I will post the letter (with links to your and Sasha's documents) so that others may use it to educate others.
Thank you for providing this invaluable data and research. It certainly explains soo much of how they were able to do all of this evil.