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The preamble for the FDA for many decades was: “The importance to the American Public of safe and effective vaccines cannot be understated.”
Over the previous century drug laws for vaccines became more and more stringent, until the US government and DoD was found guilty of violating US law and treating US troops as “guinea pigs.” In 2003 the government suffered injunctions for using their DoD patented anthrax vaccine in an investigational and unapproved manner, illegally, without our troop’s prior consent.
Beginning in 1906 with the Pure Food and Drugs Act, followed by the establishment of the Federal Food Drug and Cosmetic Act in 1938, the addition of the Kefauver-Harris amendment efficacy requirements in 1962, and finally the transfer of vaccine regulation to the FDA in 1972, every step in the historic regulatory record sought to provide increasing proof of safety and effectiveness for vaccines offered to the American public.
The ever-increasing stringency of vaccine regulation changed, was adulterated, in 2005 with the first-ever application of the Emergency Use Authorization (EUA) for the DoD’s anthrax vaccine. The DoD’s workaround to the injunction was to offer the anthrax vaccine on a strictly voluntary basis, which was documented in the Federal Register. Was it acceptable to create a new, lower standard for vaccines? Yes, according to our Congress, but with the express proviso that the government follow the law.
The Federal Register entry could not be clearer. There would be “no penalty,” and no loss of benefits or entitlements, no job loss, and no punishments for declining administration of an investigational unapproved EUA medical product. This was the precedent application of the very first use of an EUA, because the law does not allow mandates of EUA products.
The US government created EUA law to provide a new “lower level of evidence,” “may be effective,” and “reasonable to believe” standard for vaccines provided to the American public in times of a public health emergency. But both Title 10 law, section 1107a, and laws for all citizens under Title 21, section 360bbb-3, made clear everyone had the prior consent right and “option to accept or refuse” the administration of these new, lesser known benefit vs. risk EUA products.
If it was not concerning that the US government diluted the laws pertaining to vaccines, it should be concerning that they then broke that law when announcing COVID vaccine mandates for large employers, federal employees, and contractors considering the only available products were indeed EUAs. The government added to the gargantuan fraud by re-issuing EUAs for COVID vaccine at the same time they “approved” an unavailable vaccine. Ultimately, all mandates were either declared illegal by the Supreme Court, and other Federal courts, or were ultimately rescinded by the President.
Though the government initially made the argument that mandates and “consequences” were permissible according to a Department of Justice memo, the illiterate attempt to deceive the American people defied the express context of 21 CFR 50.25 and the 2005 Federal Register precedent for anthrax vaccine. Those federal regulations and precedents clearly prove “consequences” are strictly medical in nature and that the administration of investigational unapproved medical products are strictly voluntary.
It’s vitally important Americans understand that mandates were patently illegal, both for our troops and all citizens. The core law and precedent supported the voluntary nature of EUA COVID countermeasure and vaccine programs. The government willfully ignored and violated the law and encouraged subordinate state, local and private entities to do the same.
Once our citizens and Congress digest the enormity of the fraud perpetuated, we must strive to return to the preamble of the FDA and insist on proven safe and effective vaccines for our country. Dilution of laws, while permitted, cannot coexist with a simultaneous abrogation of established medical rights upheld by the same laws. Rather than ‘moving beyond’ the COVID vaccine mandates, our government should be correcting the damage inflicted on our people.
It’s ‘reasonable to believe’ that returning to the original, unadulterated FDA standard of proven safe and effective vaccines would be healthy for our government public health officials. Reflecting on the history of vaccine regulation and resurveying the lowering of standards also ‘may be effective’ in restoring the public’s trust.