“For the EUA countermeasure pathway, you’re not required to do clinical trials… The product is designated non-investigational, so you can’t do a clinical investigation with it legally. The manufacturer may volunteer to do studies. You could do studies that are not clinical trials.
Pfizer and Moderna were lying to trial participants and even to the trial administrators….They said that we’re enrolling you in the clinical trial, but it wasn’t a clinical trial.
There were a lot of violations which would, in a normal clinical trial, immediately put it on hold or remove that site and do an investigation.” —Sasha Latypova
This is the second part of my interview with Sasha Latypova in which we discuss the petition’s arguments in detail.
The petition was filed in December 2025 by Children’s Health Defense to request that the FDA revoke the Biologics License Application approvals (BLAs) for the Pfizer and Moderna Covid-19 shots.
Latypova wrote extensive parts of the petition.
The Petition’s Core Legal Argument
Products developed under Emergency Use Authorization (EUA) cannot simply be granted Biologics License Applications (BLAs). It’s like declaring sewage to be water.
But the FDA retroactively granted Pfizer’s and Moderna’s mRNA Covid-19 vaccines full BLA approval they never legally earned. Therefore, the citizen petition argues, these products have been misbranded.
Misbranding is not a minor infraction, Sasha Latypova told me, but a federal crime that can trigger seizure, injunction, criminal penalties, and license revocation.
Why Is Misbranding Such a Big Deal?
It’s a long and difficult process to obtain BLA approval from the FDA. Under section 351 of the Public Health Service Act, FDA may approve a BLA only if the vaccine is shown to be safe, pure, and potent for its intended use. In addition, it must be manufactured in facilities that consistently meet regulatory standards.
Usually, it takes many years to obtain BLA approval.
What the FDA Requires for BLA Approval
To get an idea what’s involved in obtaining BLA approval, here is a subset of the data the FDA requires from the manufacturer:
Preclinical data: in vitro and animal toxicology, immunogenicity, and dose‑finding results supporting initiation and progression of human trials.
Clinical data: full data from all clinical phases (typically phases 1–3), including efficacy analyses, safety database, and integrated summaries showing that benefits outweigh risks in the proposed population.
Chemistry, manufacturing, and controls (CMC): detailed description of the product, composition, manufacturing process, process validation, specifications, stability data, and lot‑release testing demonstrating consistent quality.
Facility and Good Manufacturing Practice information: evidence that the manufacturing site meets requirements for organization/personnel, buildings, equipment, production controls and lab controls.
During the review process for a vaccine, the FDA requires, among other things:
Completion of adequate and well‑controlled clinical trials with sufficient follow‑up to characterize safety and effectiveness.
Standardized and validated manufacturing processes, with demonstration of lot‑to‑lot consistency and protocols for ongoing lot release.
An inspection‑ready facility at the time of BLA submission
Only then, once all regulatory criteria are met, FDA issues an approval or license letter, allowing the vaccine to be marketed in interstate commerce.
Two Pathways: Investigational and Non-Investigational
Two fundamentally different pathways exist for the development of a vaccine or drug: one is called ‘investigational’, the other ‘non-investigational.’
The investigational pathway eventually leads to BLA approval if the vaccine manufacturer fulfills all the above FDA requirements. The legal basis of this pathway is the Public Health Service Act §351 and FD&C Act biologics provisions.
The non-investigational, EUA pathway rests on a different legal basis, on section 564 of the Federal Food, Drug, and Cosmetic Act. The statutory criteria for the EUA pathway fundamentally differ from those for BLA approval.
For example, the FDA does not demand randomized clinical trials for emergency use authorized vaccines. The EUA statute (FD&C Act §564) only requires ‘available’ evidence that it is reasonable to believe the vaccine may be effective and that benefits outweigh risks.
‘Reasonable to believe’…. whatever that means. This path does not lead to BLA approval but to EUA authorization.
The Lies the FDA Lied Told the American People about Clinical Trials for EUA Vaccines
You wouldn’t know all this if all you’d read were the FDA’s claims on its public facing website regarding clinical trial standards for EUA authorized vaccines.
Luckily for us, the FDA has not updated that part of its website since November 2020 - a few weeks before Pfizer’s and Moderna’s Covid-19 vaccines were EUA authorized by the FDA.
Have a look:
Source: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
The FDA either created or updated this particular page just three weeks before the Covid-19 shots got approved in December 2020. The goal presumably was to mislead Americans into thinking that EUA vaccines could be trusted and were, in fact, safe.
Here I zoom in on the bottom paragraph. Read what the FDA says about clinical trials:
Investigational Covid-19 vaccines?? No, they were not on the investigational pathway.
Their clinical trials were conducted according to the vigorous standards of the FDA??
No, they were not. The whole reason they received EUA authorization was because they were not developed according to investigational pathway specifications.
FDA and CDC Employees Were Told the Truth About ‘Clinical Trials’ for EUA Vaccines
Now compare the public ‘information’ to the internal information provided to FDA and CDC employees during a joint FDA-CDC “Preparedness Summit” in late August 2020:
Many thanks to Katherine Watt for archiving this presentation: https://bailiwicknewsarchives.wordpress.com/wp-content/uploads/2023/07/2020.08.25-sadove-fda-cdc-regulatory-updates-use-of-mcms-table-p.-18.pdf
In this particular joint learning session, lawyer Elizabeth Sadove, Director of Medical Countermeasure Regulatory Policy, gave a presentation to bring federal employees up to speed with the regulatory framework regarding the use of Covid-19 medical countermeasures. This was about two and a half months before the Pfizer and Moderna vaccines received FDA Emergency Use Authorization.
Sadove apparently still works in the same role at the FDA. She’s listed as “Senior Regulatory Counsel, Office of Chief Scientist.”
Slide 18 of her presentation is titled “Comparison of Access Mechanisms.”
Three different pathways are listed: the regular pathway for new drug/vaccine approval under the heading of ‘Clinical Trial,’ the rarely used Expanded Access Use (EAU) pathway and the Emergency Use Authorization pathway (EUA).
I’m showing the whole slide here so that you can see the FDA logo on it:
And here zoomed in:
Here a cropped version to see the information for EUA ‘clinical trials’ more easily:
As you see, ‘clinical trials’ for vaccines on the EUA pathway are not clinical trials at all. They are not required, as already pointed out, but if done nonetheless, they’re a complete joke:
They are not likely to determine if the vaccine is effective.
They might or might not result in understanding if the vaccine is safe or not.
They are not likely to produce information to benefit future patients
There is no systematic data collection.
Informed Consent is not required but the ‘volunteer’ has the right to refuse.
An Institutional Review Board (IRB) is not required.
“Large” numbers of patients can be enrolled in the trials.
Pretty interesting, right? Is that what you suspected when you read on FDA’s website that “these clinical trials are being conducted according to the rigorous standards set forth by the FDA”?
Why, you might ask, even bother to conduct such meaningless clinical trials? Well, there was an excellent reason:
The FDA had to create the appearance of a safe and effective vaccine to get the toxic fluid into the bodies of hundreds of millions of Americans.
No Liability, No Good Manufacturing Compliance, No Enforceable Product Recall
Here is another table that shows fundamental differences between the BLA and the EUA pathways.
GMP compliance means that the products are developed according to Good Manufacturing Practice regulations. They are not required for EUA products.
Liability? Not for EUA products. That would bankrupt the country. The Covid-19 vaccines were medical countermeasures covered by the PREP Act. Wait - were? I wish. They actually still are - even in their shiny new BLA garment: the Covid-19 vaccines remain protected from the American people behind the shield of the monstrous PREP Act. Wonder why.
Product recall? The FDA doesn’t require it for EUA. Why would they? It’s sewage anyway. Has there ever been a recall for sewage? The manufacturers are permitted to recall product voluntarily, out of the goodness of their hearts, but who’d be crazy enough to do that?
Declared Metamorphosis
Can a product developed for EUA use undergo a metamorphosis and emerge as an investigational, BLA approved product? Not even Kafka would think this possible: a product developed under EUA is just lightyears away from BLA-compliance.
But so what? That didn’t stop the FDA leadership: it simply declared the products BLA compliant. Who was going to stand in their way?
The Petitioners’ Requests
But now a small band of citizen petitioners has crossed the FDA’s path.
The petitioners - Mary Holland, Brian Hooker, Kim Rosenberg and Ray Flores - request that the FDA revoke all BLAs for every Covid-19 mRNA vaccine and re-designate the products as EUA biologics.
Will the FDA fulfill these demands? The answer depends on whether one believes in miracles.
As a non-believer, I’m looking forward to Children’s Health Defense suing the FDA for misbranding Pfizer’s and Moderna’s Covid-19 vaccines.
CHAPTERS
0:00:05 Citizen Petition Overview and Claim of Vaccine Misbranding
0:01:38 FDA’s Original Mandate: Misbranding, Adulteration, Interstate Commerce
0:02:35 Federal vs State Authority and Possibility of State‑Level Divergence
0:05:04 Misbranding as a Serious Federal Crime and FDA’s Dormant Powers
0:05:36 Investigational vs Non‑Investigational (EUA) Pathways
0:09:02 PREP Act Origins and Congressional Justification for EUA Countermeasures
0:13:08 No True Clinical Trials: EUA Products and “The Trial Charade”
0:14:46 Brooke Jackson’s Case
0:22:59 Media Framing: “Technicalities” vs Binding Law on Labeling and Pathways
0:27:39 Core Demands of the Petition: Revoke BLAs, Re‑Designate as EUA Products
0:29:43 Informed Consent, Nuremberg Legacy, and the Missing IRB Oversight
0:32:45 EUA Products Cannot Be Mandated – Yet Mandates Were Imposed Anyway
0:34:53 EUA Suspends FDCA Safeguards: cGMP Deviations and Non‑Regulation
0:39:56 Expiration Date Extensions and the 2069 Pfizer Lot Anomaly
0:48:46 Comparing BLA Standards vs EUA: Safety, Purity, Potency, Sterility, Identity
0:54:31 Manufacturing Process Validation and Extreme Lot‑to‑Lot Variability
1:05:30 Petition’s Legal Conclusion on FDA Violations
