This is the third, the last and, I believe, the most revealing part of my interview with Sasha Latypova about CHD’s Citizen Petition to revoke BLA status from Pfizer’s and Moderna’s Covid-19 shots.
How the FDA Built the Case for Emergency Use Authorization
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?
He does not lie: he tells the audience that taking the EUA route is the easy way out since it bypasses all of FDA’s investigational new drug/biologics regulations. However, he makes it sound like it’s not a big deal, just a convenient shortcut - what’s not to like? Travelling on the EUA highway is simply less complex than the convoluted EAU highway:
“The differences between expanded access use and Emergency Use Authorization are that expanded access use is done -- or is carried out under FDA’s investigational new drug regulations. So among many other things, those regulations require use of an institutional review board and also obtaining informed consent from recipients of the investigational vaccine according to regulations for clinical investigations -- research use of investigational vaccines.”
It’s so convenient not needing informed consent, isn’t it? And so liberating not to have an institutional review board. Fink continued:
“And so operationally speaking, an expanded access protocol would add some complexity, and that is why Emergency Use Authorization is being considered primarily as the mechanism for addressing the public health emergency that has been declared.”
Swept under the rug of “among many other things” are the near total freedom from manufacturer liability for EUA products under the PREP act and the absence of physician accountability that releases doctors from adverse event reporting obligations.
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.
This is an important point since INDs and EUAs have completely different legal foundations: Opening an IND application at the FDA is the usual regulatory pathway for new drugs and biologics. This pathway is regulated under 21 CFR Part 312.
EUAs are a totally different animal: they are authorized under Section 564 of the Federal Food, Drug and Cosmetic Act and have much lower evidentiary standards from those in the IND pathway.
So, in spring of 2020, everything looked normal with both Pfizer and Moderna opening INDs with the FDA. I added a green rectangle in Latypova’s graph below to highlight it:
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.
Such a switch from IND to EUA is not illegal and does sometimes happen. A company can go straight to the EUA pathway from the beginning or can start on the IND pathway and switch to the EUA pathway later. The green rectangle below shows the area of this first switch:
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.
The red rectangle shows the illegal switch:
Latypova told me:
“They opened IND files with FDA [in spring 2020]... By October 2020, we have a confirmation from Operation Warp Speed that they’re using the non-investigational pathway. So this IND file is inapplicable now. So they switched to this EUA countermeasure pathway and they completed their programs, including their so-called clinical trials, which are not clinical trials, the phase three studies under this EUA.. and then they went on the market [in December 2020]. And then, in August of 2021, we have this magical BLA approval… How did they jump from the sewage pipe to the water pipe? And they’re claiming that they did... they’re just lying about this…And so since 2021 they’re issuing new versions, cranking out new products.”
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).
Latypova is likely the only person who took the time to read through about 700 pages containing the data about Moderna’s nonclinical (i.e. animal and laboratory) program for its Spikevax: “So this is all from Moderna’s nonclinical program, which is based on a production obtained by Judicial Watch in 2022. And to my knowledge, I’m the only person who read 700 pages of total nonsense. It took me several weeks to just read and try to make sense of it. And to date, nobody else has commented on it.”
She showed me several pages with summary tables of Moderna’s nonclinical program so that people, she said, could see with their own eyes what Moderna had done.
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 did they use instead? Bad Laboratory Practices?
Manufacturers, Latypova said, can do “as many non-GLP studies as they like, but they’re not applicable to approval.”
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.
Good Laboratory Practices apply to studies involving:
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: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58
To grasp the enormous scope of these requirements, it’s worthwhile to read the following description of Good Laboratory Practices here:
“21 CFR Part 58, laboratories must operate within a structured quality system that includes trained personnel, validated equipment, written procedures, accurate documentation, and independent quality assurance oversight. Every aspect of study design, data collection, and reporting must follow established protocols to maintain transparency and traceability.
By requiring consistency and accountability throughout the research process, GLP protects against data manipulation and ensures that results accurately reflect study outcomes. Compliance with these standards provides scientific credibility and regulatory confidence, forming the foundation for the safe and ethical advancement of products through the FDA approval process.”
There are additional “Good Practices” FDA regulations for later parts of the drug development process. For human clinical trials there are “Good Clinical Practices” (GCP). For drugs/biologics manufacturing there are “Good Manufacturing Practices” (GMP).
So what does it mean that all pharmacology studies done by Moderna for mRNA-1273 were not compliant with GLP? It means that we have no idea what practices they used for their studies. All we know is that Moderna didn’t comply with the required standards. Which in turns means that the product was unqualified to receive BLA licensure (but got it anyway).
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.
Apparently, five different NIH Vaccine Research Centers ran Toxicology Studies for Moderna:
Excerpt from above:
Moderna outsourced half of its pharmacology studies to the NIH.
“And that’s why,” Latypova said, “the NIH received a lot of money, something like $400 million. So the US government, NIH specifically,... profited from this handsomely.”
To summarize, the entire pharmacology section from Moderna’s nonclinical package is non-GLP compliant, including the studies done for Moderna by 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.
Tissue distribution studies are pharmacokinetic studies that track where a drug or biologic ends up in the body. The goal is to discover in which tissues and organs the product accumulates and for how long it remains there.
On the FDA’s website, you can find a guidance document for tissue distribution studies. Let’s have a look:
The FDA says in its guidance that such studies are ‘essential in providing information on distribution and accumulation of the compound.’ This guidance was last updated towards the end of April, 2020. Sounds like it’s important to get this study right, wouldn’t you say?
Let’s see if it was important for Moderna to get it right. Here are the details of Moderna’s tissue distribution study:
Was the study GLP compliant? No.
Did the study test the tissue distribution of mRNA-1273? I would assume in order to find out about the tissue distribution of mRNA-1273 (Spikevax), one would have to test mRNA-1273 - and not something else.
But no. Look at the large red circle on the left: Moderna did not test mRNA-1273. It tested something called mRNA-1647 instead.
So what the heck is mRNA-1647?
Latypova explained:
“The study was done with bananas instead of apples: with mRNA-1647, which is not Spikevax.
Spikevax is mRNA-1273 and they’re testing mRNA-1647. And 1647 is an unapproved, experimental product consisting of six different mRNAs, which Moderna was studying for cytomegalovirus in 2017.
So they dusted up their shelves. They found this study from a program that failed in 2017 for a product that wasn’t approved, that wasn’t Spikevax, that was conducted non-GLP and submitted it as a key tissue biodistribution study for Spikevax.
And there is no other tissue distribution study that they’ve done.”
Here is the part of the slide above that describes what mRNA-1647 contains; it also shows abbreviations. ‘CMV’ means cytomegalovirus, a common virus belonging to the herpes family.
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.
Did the FDA raise objections against getting a tissue biodistribution study for a different mRNA biologic meant for a different virus? No.
Did Moderna later on submit a proper tissue distribution study to the FDA in order to obtain BLA licensure? Did the FDA request Moderna to submit such a study for BLA approval? No and no.
“Just appreciate,” Latypova said, “that FDA reviewers are not children from the street. They’re professionals. They know all this that I’m saying. And they sit there, close their eyes and say, ‘It’s all okay.’”
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.
You only need to look at the title page to see that the study doesn’t fulfill BLA requirements in three crucial ways: It tests the wrong product, it doesn’t use Good Laboratory Practices and it’s tested only on male rats. Charles River Laboratories was clearly in on the fraud and went along with it. It likely did simply what Moderna told it to do.
Is it legal for the FDA to grant BLA approval to a product that did not fulfill nonclinical study requirements? No, it is not.
Latypova said: “You can’t do that by US law. You have to study a representative product and you have to study it in the population for which it will be indicated. And obviously they didn’t.”
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.
Instead, five other mRNA biologics were used in six tests. The one in the red rectangle we already know: it’s our old friend mRNA-1647 that was used in the tissue biodistribution study.
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.’”
It was all for show.
The goal was to get the toxic Covid-19 shots into the bodies of hundreds of millions of Americans without any accountability from manufacturers and federal agencies. To reach that goal, the federal government, in collaboration with the pharmaceutical industry, media and big tech, stripped citizens of their civil rights, lied blatantly to the public, deceived the public and forced millions of Americans to be injected.
The studies shown are just a few examples among many. In its Citizen Petition, Children’s Health Defense goes over lots of other such studies that show no compliance whatsoever with biologic licensing standards.
BLA approval was granted to Moderna (and also to Pfizer) on the basis of piles of paper that really were piles of sh*t.
Misbranding is way too nice a word for this crime.
CHAPTERS
0:00:05 FDA–Operation Warp Speed meeting and shift to EUA pathway
0:02:52 IND filings, non‑investigational “countermeasures” route, “magic leap”
0:05:20 Legal meaning of IND and investigational status
0:08:28 Introduction to Moderna’s nonclinical program: Judicial Watch FOIA records
0:09:54 Non‑GLP pharmacology studies and NIH involvement
0:11:34 Flawed biodistribution study: wrong product, non‑GLP, male‑only rats
0:15:52 Toxicology with non‑representative mRNAs
0:18:21 Systemic BLA non‑compliance and objectives of the citizen petition
0:21:07 PREP Act as governing law & misbranding argument
0:26:23 Informed consent, PREP Act, RFK Jr’s role & doctors’ ethical dilemma
