FDA must disclose more COVID-19 vaccine records, US judge rules
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FDA is ordered to produce 1 million more pages of Pfizer's Biologics License Application for covid injections
Chemistry Manufacturing Controls documentation has not been produced yet. I hope it will be now. Does it even exist?
By Sasha Latypova | December 10, 2024
This is a quick post to let my readers know that the FDA has been ordered to produce 1 million additional pages from Pfizer’s dossier. The case is litigated by Aaron Siri, and my congratulations to him for this win!
This is the data that the FDA supposedly relied on to issue a [fake] Biologics License Approval (BLA) for Pfizer's original "Wuhan variant" covid shot. That version of the shots has since been removed from the market, and replaced with new versions without any clinical trials whatsoever.
It has been my position that the BLA is fake because the "EUA Countermeasure" regulatory pathway is non-investigational, making it impossible to conduct clinical investigations, i.e. legally protected human experiments. Thus, it is akin a train track or a bridge to nowhere. More about this issue in the posts below.
Questions from readers about EUA Countermeasures
SASHA LATYPOVA · FEB 13
Question from Meryl Nass referring to the statement in my “Summary of Everything” that EUA countermeasures could not be tested for safety or efficacy in accordance with US law (21 CFR 312 and 21 CFR 601), nor could compliance with current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GxP in general) be enforced by the FDA due to the statutor…
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EUA Countermeasures are neither investigational nor experimental!
SASHA LATYPOVA · DEC 3, 2023
EUA Countermeasures are neither investigational nor experimental! "Judge, I was forced to take an experimental vaccine!"
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I have been advocating for nullifying this very bad law that authorizes unregulated poison to be made "available" and pushed via mandates, coercion, threats and propaganda onto unsuspecting public. I have been advocating for removing the entire Chapter 564 that pretends to "regulate" EUAs from the Food, Drugs and Cosmetics Act.
I previously wrote about this case, and provided a solicited opinion to The Defender/CHD publication:
I published several in-depth analyses dealing with the scientific and regulatory fraud that was uncovered, specifically the review of non-clinical study package which showed that the product had several mechanisms of severe toxicity, and that it was damaging to the reproductive function. This review also showed that Pfizer, with complicity from the FDA, committed numerous scientific and regulatory fraud, passing irrelevant studies, omitting necessary studies, and using improper study designs to obfuscate potential for great harm:
Please go to substack to continue reading and view images.
I previously wrote about this case, and provided a solicited opinion to The Defender/CHD publication:
MRNA, GENE THERAPIES AND BIOMANUFACTURING FRAUDExcerpt from the article linked above, explaining the critical importance of the Chemistry Manufacturing Controls documentation.
The FDA asks the court to stop producing Pfizer BLA documentation
SASHA LATYPOVA · OCT 23
The FDA asks the court to stop producing Pfizer BLA documentation
My readers are well aware of the FOIA lawsuit won by Aaron Siri in the U.S. District Court for the Northern District of Texas, which resulted in a court mandate to produce ~55K pages of Pfizer BLA documentation per month by the FDA. The suit was filed by Aaron Siri on behalf of the
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I published several in-depth analyses dealing with the scientific and regulatory fraud that was uncovered, specifically the review of non-clinical study package which showed that the product had several mechanisms of severe toxicity, and that it was damaging to the reproductive function. This review also showed that Pfizer, with complicity from the FDA, committed numerous scientific and regulatory fraud, passing irrelevant studies, omitting necessary studies, and using improper study designs to obfuscate potential for great harm:
Did Pfizer Perform Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies?Every month I inquired with my colleagues whether anything looking like Chemistry Manufacturing Controls (CMC) documentation was produced among these pages. No such materials have been included in the 1.2 million pages produced to date. The reason I was interested in that documentation is because many of us have also seen the package of CMC review materials that was leaked from the European Medicine's Agency (EMA) in December 2020. I and several other colleagues published extensively on the woefully inadequate state of manufacturing at the time when the shots were deployed commercially world-wide. The senior staff at the EMA were stating in internal communications right around the initial commercial launch that "CMC issues" were going to be "the difficult bit". Importantly, they are saying that the FDA told them this, i.e. the knowledge of the CMC problems originated at the FDA:
Sasha Latypova January 1, 2023
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Please go to substack to continue reading and view images.
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As expected. The crime cartel needs its protections, desperately:
Would anyone expect anything different from this corporate fascist regime?
The people responsible for this are not going to simply walk away and end their bioweapon assault on humanity:
Same title but different content:
Vaccines (injections) become RNA "therapeutics":
Arcturus Therapeutics is seeking approval from the FDA to go ahead with self-replicating bird flu vaccine trials
The FDA will still remain a federal "government" corporation:
Editor's note: Apparently, this *sshole drug pusher screwed up spilling the beans by saying "it all starts on January 21st". Do people want to know the actual reason this *sshole who is an actor pretending to be a doctor is talking about the exact date a new virus will be released? Because the biotechnology market is expected to reach around $4.61 trillion by 2034. The amounts of money the biotechnology industry is expected to rake in over the coming ten years is staggering. That is why these drug salesmen will say the most outrageous shit like this guy. And it is all based on the falsification of science on what viruses are.
NOT A HOAX: Countless new viruses to be released the day Trump takes office.
December 6, 2024 | By Jim Stone Journalist
OMG THIS IS A CLASS A BLOOPER, Nationally acclaimed Vaccine researcher Peter Hotez TOTALLY screws up and spills the beans by saying it all starts January 21.
It's not what he is saying in specific, it is THE DATE HE PUTS ON IT, which proves their next step is open biowarfare on the American public starting Jan 21. Why that date? Because it is the plan against Trump, and this idiot blew the plan WIDE OPEN.
HERE WE GO! Vaccine researcher Peter Hotez says multiple viruses will be unleashed on America the day after Trump takes office
— Breaking911 (@Breaking911) December 4, 2024
“We have some big picture stuff coming down the pike starting on January 21st.”
pic.twitter.com/SlGrvBddsC
Look at him keep a straight face while saying the date. He's a total psychopath.
THERE YOU GO FOLKS, THIS TIME WE WERE LUCKY SOME IDIOT TALKED ABOUT "911" BEFORE IT HAPPENED, AND THERE IS NO GUESSING ABOUT IT, THEY ARE GOING TO DO IT, ARCHIVE AND POST!!!
Gleefully laughing and hand wringing. Too good. Just too good. On X too, where it is safe.
NOT coincidence, this is the plan, and you can bet there was NOT H5N1 in cattle in March, that's just the cover story.
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"We've got lots of new viruses starting January 21st!" – Dr. Peter Hotez
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