Big thanks to Cornelia Flashlights Podcast for putting together these detailed discussions on the Moderna non-clinical “studies” on which the FDA issued [a very fake] Biologics License Approval for their Spikevax mRNA injections. This material is part of the Citizen Petition by Children’s Health Defense which is based on my research and materials.
This video is Part 3 of the discussion. See Part 1 and Part 2. I am republishing Cornelia’s excellent summary and my powerpoint slides included in this discussion below:
In October 2020, only two months before the FDA granted Emergency Use Authorization to Pfizer’s and Moderna’s Covid-19 mRNA shots, the FDA’s ‘Vaccines and Related Biological Products Advisory Committee’ (VRBPAC) held a public meeting to discuss the various regulatory pathways for the shots.
During this meeting, Dr. Doran Fink, then deputy director of FDA’s Division of Vaccines and Related Products Application, gave a presentation in which he built the case for choosing the Emergency Use Authorization pathway.
In his role as deputy director Fink was directly involved in the FDA’s decision to grant EUA authorization to the shots. Fink left the FDA two years later and started working for Moderna shortly after. So the same guy who had been instrumental in driving the decision to follow the Emergency Use Authorization pathway for the Moderna shots shortly after ended up working as ‘Clinical Therapeutic Area Head’ for Moderna. Presumably a golden thank you from the company that made a killing with the shots.
Fink’s career has been progressing nicely ever since: he’s now the head of Global Regulatory Strategy at GlaxoSmithKline.
Source: https://www.linkedin.com/in/doran-fink-md-phd-473a20a3/details/experience/
The Real Purpose of the Meeting
What was the true purpose of this public meeting? Usually the VRBPAC meets to discuss specific vaccine candidates - but not so in this October 2020 public session. Was this a policy debate to have a real discussion about which regulatory pathway to follow? Hardly. It was way too late for that - just two months before the shots were approved under EUA. The deadline for approving the shots had long before been fixed for the end of 2020.
More people than usual attended the October meeting, forty in total: Over half of those were government agency staff from the FDA, CDC, NIH and BARDA. Thirteen were academic experts. Just three were neither government nor academia. One of them worked for Merck.
The true purpose of the meeting appears to have been to legitimize the use of the EUA pathway, watch out for any objections from the large audience and, should they occur, refute them.
Basically, it was a carefully orchestrated EUA marketing and consensus building session.
Marketing the EUA as a Convenient and Hassle-Free Shortcut
The transcript of the meeting is fascinating to read. Here is one particularly pertinent part of the transcript:
Reading this page was a lightbulb moment for Latypova, she told me. Here was irrefutable evidence, provided in a public hearing, that government officials had carefully chosen the EUA pathway exactly because of the choice’s grave implications.
Dr. Kurilla, a senior NIH scientist, asked Doran Fink: “Did you consider at all the possibility of an expanded access protocol… instead of an EUA?”
Expanded Access Use (EAU) is another regulatory pathway created for patients with life-threatening conditions so that they can access not yet approved medical products outside of a clinical trial. Importantly, EAU is an investigational pathway because it allows patients to access investigational (but not yet approved) medical products - like drugs or biologics.
Emergency Use Authorization is completely different: It’s not an investigational pathway at all. EUA products are not under scientific investigation and do not have to comply with FDA’s usual regulations.
If the FDA had opted for the Expanded Access Use pathway for the Covid-19 shots, then the following conditions would have been to be met:
Every vaccine recipient is treated as a clinical trial participant.
IRB oversight is required at every administration site.
Physicians administering the vaccine carry formal investigator responsibilities and liability.
Informed consent documents explicitly describe the investigational nature of the product.
Individual adverse events are fed back into a formal IND reporting structure.
How did Fink respond to this pivotal question whether FDA’s Vaccines and Related Biological Products Advisory Committee had considered following the Expended Access Use pathway?
The Magic Leap
Below is a graph from Latypova’s December 2025 presentation titled “Covid mRNA vaccines are misbranded: EUA Countermeasures in Disguise.”
It shows two switcheroos: In the spring of 2020, both Pfizer and Moderna opened so-called INDs, Investigational New Drug applications, with the FDA. So they did not start on the EUA pathway. They could have gone directly to the EUA pathway, but chose not to.
In October of 2020, the same month in which the VBRCAP meeting described above took place, the first switch happened: both companies changed tracks by jumping from the IND pathway to the EUA pathway.
The second switch came in August 2021: the switch from EUA authorization to full BLA licensure. This switch is not legitimate because none of the conditions for BLA licensure had been fulfilled.
Latypova told me:
Moderna’s Nonclinical Studies Are a Massive Deception Exercise
Through a FOIA lawsuit, Judicial Watch obtained the data Moderna had submitted to the FDA for BLA approval of its mRNA-1273 vaccine (later named Spikevax).
Moderna’s Non GLP Pharmacology Studies
The table below shows Moderna’s pharmacology studies for its Covid-19 mRNA shot. Have a look at the word inside each one of the red circles in the GLP (Good Manufacturing Practices) column.
Yes, you read that correctly: it’s a ‘no’ for every single toxicology study. None of the studies are GLP compliant. Moderna did not use Good Laboratory Practices when conducting the toxicology studies.
What are Good Laboratory Practices (GLP)?
In the United States, GLP is codified under 21 CFR Part 58: “Good Laboratory Practice for Nonclinical Laboratory Studies.” These practices apply exclusively to nonclinical studies and are enforced by none other than the FDA. Their primary purpose lies in ensuring the quality, integrity, and reliability of nonclinical studies’ safety data that pharmaceutical companies submit to the FDA.
Toxicology and pharmacology testing in animals
Biodistribution and pharmacokinetic studies
Genotoxicity, reproductive toxicity, and carcinogenicity studies
Food additives, pesticides, medical devices, and biological products
You can read the full text of the GLP regulation here: it’s pages upon pages of specific requirements regarding, for example, lab equipment, procedures and quality assurance:
The NIH Did Some of Moderna’s Toxicology Studies
Let’s return to the toxicology graph. Have a look at the letters in the orange circles: they all start with the letters VRC. What’s VRC? It’s a Vaccine Research Center of the National Institutes of Health (NIH). The numbers refer to different NIH Vaccine Research Centers.
Excerpt from above:
Moderna outsourced half of its pharmacology studies to the NIH.
Moderna’s Tissue Distribution Study Was Done With Bananas Instead of Apples
As part of its nonclinical studies, Moderna did a key tissue distribution study for Spikevax and submitted it to the FDA.
Source:
Was the study GLP compliant? No.
Moderna tested the tissue biodistribution of an mRNA vaccine against herpes and submitted it to the FDA for approval of mRNA-1273. It did this while on the Emergency Use Authorization pathway. You see, that pathway really is a sewage pipe - everything goes.
Moderna Outsourced Its Biodistribution Study
Below you see the slide with the title page for the mentioned tissue biodistribution study:
Charles River Laboratories is a contract research organization (CRO). Moderna and other pharmaceutical companies pay CROs to conduct preclinical and clinical studies on their behalf. The Montreal facility where the tissue biodistribution study was done is just one of many such Charles River Laboratories’ sites.
Toxicology Studies Done on Five Random mRNA Products
On the graph below you see the toxicology section of Moderna’s nonclinical studies.
As you see, the toxicological studies are all GLP compliant. But have a look at the colorful rectangles on the left: not a single product they tested was mRNA-1273.
What Was the Purpose of Submitting All These Nonsensical Studies?
The purpose, Latypova says, was to “just produce a pile of paper to say, ‘we did a lot of things and yeah, maybe it’s not totally complete, but it’s mostly good.’”
CHAPTERS
0:00:05 FDA–Operation Warp Speed meeting and shift to EUA pathway
RESOURCES
Sasha Latypova Breaking: Citizen Petition to the FDA filed by Children’s Health Defense with my input.
PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Art for today: Study of Tuesday, oil on panel. Available art here.
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