DRAFT Amicus Curiae Brief Cover
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Excerpt from the Draft Amicus Brief, regarding recent analysis of FDA documents.
By letter dated August 23, 2021 the FDA granted partial approval for future production of one of the injections (that of the Pfizer drug company).
Reading the actual letters that the FDA sent to Pfizer it is clear, in the sense that the term “FDA approval” is generally understood, there was no full FDA approval. All available COVID inoculations are still under EUA (Emergency Use Authorization). They are still experimental drugs clearly subject to Informed Consent and not subject to any “mandating” either by governmental agencies or private actors (such as employers and educational institutions) acting under color of law.
The Agency sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.[1]
The first letter approves Pfizer’s application for a license to label its COVID-19 drug with the brand name COMIRNATY. It also states the terms and requirements for nine additional clinical trials over five years, with yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis following administration of the Pfizer drug. The license to label and manufacture is not a full approval of the drug, still subject to years of clinical trials.
The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY.
The Agency commanded the manufacturer to continue to study the adverse events that are to be expected from this class of drugs, stating on Page 6,
“We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies: [Redacted.]”
Thus the COVID injections remain either subject to the Emergency Use Authorization, which is specifically conditioned upon respect for Informed Consent or, when produced under the new approval, will remain in an experimental state clearly subject to Informed Consent. The use of sanitary masks and certain medical tests remain under Emergency Use Authorization.
Background:
http://www.opensourcetruth.com/two-jab-cases-heading-to-scotus/
Sources:
BLA Approval: https://www.fda.gov/media/151710/download
EUA Extension: https://www.fda.gov/media/150386/download
Further information: http://www.opensourcetruth.com/two-jab-cases-heading-to-scotus/
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