This is the first part of a long interview with Sasha Latypova.
We discuss the Citizen Petition filed in early December 2025 by Children’s Health Defense asking the FDA to revoke the Biologics License Application approvals (BLAs) for Pfizer and Moderna Covid-19 shots.
Latypova wrote extensive parts of the petition and, in the second part of the interview, we will go over the petition in detail.
An Analogy
It’s all pretty confusing with these toxic mRNA Covid shots. At first they were under Emergency Use Authorization, then the FDA gave them BLA approval but continued to give the EUA shots for more than a year after BLA approval to most Americans. And what role does the PREP act play in all this?
To quickly understand the basic concept of the BLA approval game that the FDA has played, imagine the following: you wake up one morning to the news that the federal government declared sewage to be in compliance with the Safe Drinking Water Act (SDWA). And the EPA has confirmed that sewage complies with the agency’s established health-based standards for contaminants in public drinking water.
You turn on your faucet. And, sure enough, sewage comes flowing out of it.
If you decided to drink it, you wouldn’t be able to sue the government when you get sick because sewage has been declared a medical countermeasure under the protection of the PREP act, granting freedom of liability to all municipalities, waterworks etc. in the entire country.
This analogy only goes so far though: after all, before the government declared sewage to be compliant with the Safe Drinking Water Act, it didn’t put sewage under some kind of Emergency Use Authorization and it didn’t mandate you to drink it in order to keep your job.
PS: This analogy is only meant to highlight the difference in regulatory pathways between EUA authorized and BLA licensed biologics. That’s all. Because the BLA Covid shots are as toxic as the EUA shots. They served us sewage from the start.
From Emergency Use Authorization to BLA Approval
In December of 2020, the FDA issued Emergency Use Authorizations for both Pfizer’s and Moderna’s Covid-19 ‘vaccines.’
Under Emergency Use authorizations, products like drugs, biologics and devices are not required to comply with FDA’s safety regulations.
Only eight months later, in August of 2021, the FDA issued BLA approval for Pfizer’s Covid‑19 shots, followed by BLA approval for Moderna’s shots several months later, in January of 2022.
What is BLA Approval?
BLA stands for Biologics License Application. It’s the application that a biologics manufacturer submits to the FDA after clinical development.
In order to have the application approved by the FDA, the product must be compliant with the safety regulations, standards and controls of the Federal Drug Administration. By giving a biologic BLA approval, the FDA declares the product safe, pure and potent for its specific use.
The BLA licensed versions of the shots are not under Emergency Use Authorization, reason being that they have been declared to be in full compliance with FDA’s rules and regulations. There was therefore no reason to have them emergency use authorized.
The BLA approved version of Pfizer’s shots is called Comirnaty. For Moderna, the BLA approved version is called Spikevax.
What is the Difference between the EUA Versions and the BLA Versions of the Covid-19 Shots?
In terms of product, they are the same: same mRNA, same lipid nanoparticles, same everything.
In terms of liability protection for manufacturers and others who transport, market and administer the products, they are also the same: Both are covered under the PREP’s act liability shield until December 2029. A drug, device or biologic can be fully FDA approved or licensed and still be covered as medical countermeasure under the PREP act.
But, as described above, in terms of regulatory status, they are two different animals. One is exempt from the usual FDA regulations, the other one has to comply.
Did Americans Receive the BLA Versions of the Shots after BLA Approval?
No, they did not.
They continued, for the most part, to receive the EUA versions.
Why was it that Americans were injected with the EUA versions until around the beginning of 2023, about 18 months after the BLA approval was issued? Was it even legal to inject them with EUA products after BLA approved shots had become available? Indeed it was.
EUAs Remained in Place after BLA Approval
And the reason it was legal was that when the mRNA shots received BLA approval, the EUA authorizations remained in place for the original Pfizer and Moderna shots.
In fact, the EUA for the shots were only removed in late August of 2025, just 5 months ago.
Which means that the EUA that was issued in December of 2020 for the Pfizer and Moderna Covid-19 shots was in place for almost 5 years.
Isn’t it curious that the EUAs were not revoked from products that were not compliant with FDA rules when the same products became available in a fully FDA compliant version?
That makes no sense, does it? And wasn’t that a very risky thing to do? Wouldn’t there be an outcry if people noticed?
But people didn’t really understand the game that was being played and no wonder, because it was all enormously confusing back in August of 2021.
Outside of the circle of perpetrators, nobody had yet quite grasped what was happening. EUA was confused with EAU and nobody really understood the significance of the Emergency Use Authorization for a while. Government/media propaganda, disinformation and extensive censorship assured that people were confused and disorientated.
Latypova told me that it is not entirely clear why the EUA shots were used for so long after BLA approved shots became available. Was Pfizer paranoid about potential legal or liability issues despite being protected by the PREP Act? Was it to use up the huge number of already purchased EUA shots before ordering the BLA versions?
Or was it because the EUA version was, from an all around cover-your-ass point of view, the better one because of its extraordinary EUA status?
FDA Fraudulently Gave BLA Approval to Pfizer’s and Moderna’s Covid-19 Shots
As already pointed out, in terms of toxicity there is no difference between the shots since the version with FDA’s seal of approval is exactly the same as the EUA version.
But, again, it does make a difference in regulatory and legal terms since EUA is a non-investigational pathway that is exempt from FDA rules and regulations.
BLA licensed biologics, on the other hand, are on the investigational pathway and must be in compliance with FDA safety rules, regulations and practices. At least that’s the theory.
The EUA Covid shots obviously had never complied or ever tried to comply with any of FDA’s regulations because they were exempt from them under Emergency Use Authorization.
So, you would think that in order to get the coveted BLA approval from the FDA, Pfizer and Moderna would have been asked by the FDA to go back to square one and start the many year long trek on the investigational pathway that might have eventually led to BLA approval.
But that’s not what happened. The FDA didn’t require Pfizer and Moderna to undergo the tests, clinical trials, manufacturing compliance standards, none of it. Instead, the FDA simply handed BLA approval out to them with the full knowledge that these products were not in compliance with any of their safety regulations. Sewage as water.
We know this now, years later, thanks to people like Sasha Latypova, Mary Holland, Aaron Siri and Brian Hooker. Back when it happened in 2021 and early 2022, there was tremendous confusion, including among experts, about what was happening with this BLA approval. It took years and many lawsuits to get the data from the FDA, Pfizer, Moderna and others to get to the bottom of the fraud.
CHD’s Citizen Petition
CHD’s citizen petition is just the first step to force FDA to remove the fraudulent BLA approval from the Covid-19 shots and revert them back to the status of EUA authorized products.
But, wait, that EUA no longer exists! It was removed in August 2025. Well, then these toxic shots that have caused so much carnage will finally have to be removed from the market, right?
Unless HSS secretary RFK decides to put them back under EUA - which is hard to imagine.
CHAPTERS
0:00:05 CHD’s Citizen Petition To Revoke Pfizer And Moderna BLAs
0:05:07 Public Response And Record Comment Numbers
0:11:06 What Are Biologics? Basic FDA Categories
0:15:18 From Traditional Biologics To mRNA “Biologics”
0:21:52 NDA vs BLA And Biologics Carve‑outs
0:27:49 Biologics, Vaccines, And Industry Incentives
0:31:19 Growth Of Biologic Drugs And Vaccine Focus
0:31:41 EUA Timeline And 2021 BLA Approvals
0:33:45 Comirnaty Rollout In US vs Europe And Relabeling Claims
0:36:15 Confusion Among Public And Doctors About EUA vs BLA
0:37:28 FOIA Delays And EUA vs EAU Confusion
0:39:40 EUA As Countermeasure Outside Normal FDA Rules
0:43:42 Sewage vs Drinking Water Analogy For EUA vs BLA
RESOURCES
Sasha Latypova Breaking: Citizen Petition to the FDA filed by Children’s Health Defense with my input.
