Questions from readers about EUA Countermeasures
Question from
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 statutory “non-investigational” nature of EUA products. Non-investigational status precludes the possibility of a clinical investigation (human trial).Sasha, I am not sure about #7. It depends when the vaccines were designated as "covered countermeasures." While there are general declarations in the Federal Register about types of products designated as covered countermeasures by the HHS Secretary, I suspect there are specific designations for specific products somewhere else. Otherwise you or I could claim we have a drug or vaccine against COVID, and it would obtain the "covered countermeasure" designation. HCQ would be a covered countermeasure, for instance.
If the vaccines were designated as CCs only when authorized, then they could have undergone clinical trials before then.
I am sorry, I didn’t see this question until now. I get a lot of notifications and simply do not see many questions or comments. It is a good question, asked by many people. Here is the answer:
Covid “vaccines” were designated as EUA countermeasures at the latest by October 22, 2020. In fact, I believe Pfizer switched to the EUA by July 2020, as they started mass commercial manufacturing of their vaccines in August 2020 (this would have been illegal under IND, but is legal for EUA). Here is the transcript from the FDA meeting on that date clearly saying so:
Doran Fink says Emergency Use Authorization is their regulatory pathway, and not the Expanded Access Use. The EUA exists ONLY under PREP Act, and ONLY as a countermeasure. Here is a powerpoint from the FDA lawyers discussing this.
How this works in practice:
You or I can claim we have a vaccine against obesity and claim that since obesity is a dangerous global pandemic, our vaccine should be designated as a EUA countermeasure. I am going to describe the entire regulatory pathway for having something designated as an EUA countermeasure. It consists of 2 steps:
Step 1: Xavier Becerra (or his successor) SAYS that there is a pandemic of obesity caused by a virus. He can also say there is a potential for pandemic of obesity caused by a virus - that is the minimum he needs to claim to declare a pandemic.
Step 2. Xavier (or his successor) SAYS our vaccine product is a countermeasure for this pandemic of obesity.
Step 0: DOD identifies obesity virus by scouring remote caves in Southeast Asia for bat and pangolin droppings, then designates this virus a national security threat after PCR-ing a handful of cases in the US. Robert Malone writes a 100 page book on “how to prepare for obesity virus pandemic” in 3 weeks. Boom. We are good to go!
The end. Product gets issued an EUA, and as long as Xavier or his successor can claim there is a potential for an obesity pandemic, we are good. The government will be buying and stockpiling our obesity vaccine in the Strategic National Stockpile and CDC will put it on the childhood schedule. Isn’t this great?
Ask me how to convince Xavier to say there is a pandemic of purple unicorns and my purple unicorn spray is a safe and effective EUA countermeasure, and the US government should purchase $10 billion worth of it. I think we all know how to make Xavier say so.
Additional questions from readers:
Why is the FDA issuing Emergency Use Authorizations for fully approved "vaccines"?
"On September 11, 2023, the Food and Drug Administration (FDA) approved the updated (2023–2024 Formula) COVID-19 mRNA vaccines by Moderna and Pfizer-BioNTech for persons aged ≥12 years and authorized these vaccines for persons aged 6 months–11 years under Emergency Use Authorization (EUA). On October 3, 2023, FDA authorized the updated COVID-19 vaccine by Novavax for use in persons aged ≥12 years under EUA."
This gets to the FDA saying that “approved” and EUA versions can co-exist. It is true that an investigational product, previously FDA approved using an investigational pathway (e.g. HCQ or IVM) can be used as a EUA countermeasure under declared emergency. However, any FDA approved product can be used off-label if a physician thinks it may be effective (because a full legal investigational approval process, conducted in compliance with FDCA had previously concluded that it is generally safe). That’s a physician’s discretion due to their medical training and licensing (not a lawyer’s discretion in case of Xavier Becerra).
However, an FDA-approved product can only exist if an investigational drug or device, has undergone a full set of prescribed pre-clinical and clinical testing and the manufacturer has complied with the cGxP while being subject to the IRB, informed consent and other requirements put on the investigational products by the FDCA. That has NEVER happened for covid injections.
What FDA is claiming -”full approval” for covid vaxxes - is an impossibility. It is the same impossibility as getting pregnant, having an abortion and several months later giving birth to the same baby. Not possible.
Getting pregnant = opening IND with the FDA by the manufacturer;
Having an abortion = switch to the EUA non-investigational status;
Claiming several months later the birth of a healthy full term baby = FDA issues BLA approval for covid vaxxes based on the clinical trials that switched to a non-investigational status and were never completed.
That’s why, the FDA’s “full approval” is a lie, a fig leaf. That’s why they keep issuing the EUAs while they claim they are “approved”. The FDA is certifying this fraud.
Art for today: Dragon, watercolor.
Sasha, you've got a mind like a steel trap. Wonderful. I find myself needing to appreciate the precision of your verbal scalpel, and at the same time, I need to zoom out. At the Macro level, what Ivan Illich called the expropriation of health, is the key issue. He observed in 1975 that the medical system had become the number one health threat, and it has only gotten worse since then. We are now dealing with the mass medicalization of public health. Public health is plumbing, clean air, work place safety, water treatment, seat belts even, but it is not, ever, totalitarian medical interventions without any regard for personal medical histories or preferences. Fluoridation is now on trial, and the vaccines should be next, all the vaccines. It is interesting to see Mike Yeadon now coming around to this the long way around, and observing that he will not go see a doctor, just to go see a doctor, for he correctly sees that doctors have just become pharma sales guys. It is a brilliant move, but it is a dead end, and if this mRNA fiasco is the place where it finally hits the wall, all I can say is better late then never. Our healthcare system is the biggest enabler of sickness that was ever invented, and it has become nothing less than the primary method of sucking the wealth out of nations. Truly a wolf in sheep's clothing. Health is one thing, that is lifestyle medicine in its truest forms (NOT under the auspices of the AMA, please), as we find it in the Yellow Emperor's classic on Medicine, or in Ayurveda, and we are only barely starting to find our way back to such concepts of what it takes to live a healthy life. No one whose immune system was not shot off in the war (or by the vaccines), and did not have multiple comorbidities, did have one iota to worry about whatever this Covid thing was.
My highschool chemistry teacher, God bless his heart, analyzed the medical profession as follows: The put a label on whatever you report, they prescribe a chemical they have no idea what it does, and if you don't come back, they declare it a success. Today, he would be put in jail for doubting the high priest of the AMA. US Pravda is the medical mafia.
Sasha, it never stops to amaze me how clear, concise and well written/structured your explanations are. So refreshing! How is it that you are the only one (almost) to contextualise everything (almost) so clearly and quickly (relatively) is kinda puzzling (or not)?
Thank you for your relentless clarity. It is so rare to meet someone who goes deep enough while being crystal clear & succinct! Amazing!