The FDA’s Emergency Use Authorization for the vaccines was based on clinical trials and manufacturing processes conducted with no binding legal standards, no legally proscribed safety oversight or regulation, and no legal redress from the manufacturer for potential harms. (This last point is being challenged in multiple court cases, so far to no avail.)
In keeping with the declaration of war, it was a military framework that was used for acquiring the aspirational products that became known as Covid mRNA vaccines.
Actually, it is unclear from the wording of the OTA whether the "Prototype" applies to the mRNA Covid vaccine, the mRNA platform for manufacturing the vaccine, the actual manufacturing of 100 million vaccines, or all of the above.
The two regulations applied to the authorization of the Pfizer mRNA Covid vaccines were EUA and its partner, the PREP Act, which grants legal immunity from prosecution to anyone who has anything to do with the vaccines, unless they commit outright fraud.
For this reason, EUA products do not require the type of legal safety oversight that is applied in civilian contexts by the FDA. And without adherence to legal safety standards in clinical trials and manufacturing, there is no way of knowing whether the products, in this case the Covid mRNA vaccines, are actually safe.
That's what the "Safe and effective" claim for the BioNTech/Pfizer Covid mRNA vaccines was based on in December 2020, when millions of people - including children and pregnant women - were mandated to take the injections.
Trying to charge pharmaceutical companies with wrongdoing related to Covid vaccines has failed, because the EUA + PREP combo means they were not required to apply any legal/regulatory standards to their clinical studies or manufacturing processes.
https://brownstone.org/articles/covid-mrna-vaccines-required-no-safety-oversight/
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