July 15, 2023

Adulteration of Vaccine Safety and Efficacy

July 15, 2023
5 Comments

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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.

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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.

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Johnny Dangereaux

How about we eliminate the FDA NIH CDC and all those that screwed us all over?
We don't need "reform" we need an enema!

R.Baker

May I first say that I find it very refreshing to find a publication in Colorado once again that doesn't write every word from somewhere waaaaaay away out in left field? I had honestly given up on being able to read about CO- based issues without a liberal bias, and just last week cancelled my Tribe subscription. Ever since the Denver Post took the helm, it has been trying to export the crazy Denver mindset to Greeley and environs, and lost ever more subscribers as a result.
As to your assertion that returning to the old policies by the FDA might restore faith in th e institution once more, I have to tell you that I believe that you're being unrealistically optimistic. Many of us,including and perhaps e specially those of us with backgrounds in medical care professions were growing suspicious of the FDA and their recommendations long before the planet tipped off of its axis and became unrecognizable. Too many of our real-world experiences were just not corresponding with the official expectations / projected outcomes, for one. Any questions or attempts to re-examine the methodologies or results were met with resistance. That's not the scientific way. Then, with the succession of lies they told us regarding the pandemic, the eagerness with which they embraced their enhanced abilities to assert control and the hesitancy to release it again; The insistence that no voice of dissent or argument be allowed, nor meaningful discussion of alternative therapies or treatments; Acting as if every human in the country was not as smart as they, and could not make devisions for themselves any longer but must be treated like willful children; Treating our medical professionsls and researchers as if all of their education and experiences were so much garbage and threatening their licensure and livelihoods when/if they dared to do what their logic advised them to in order to save their people; The unapologetic attitudes after so many lies and so much destruction; And of course, the recent admissions by upper management types that the pharmaceutical companies have never done any of the safety studies required by law prior to requesting certifications for vaccines now permanently mandated into our childrens' bodies for the foreseeable future; And failure to meet many to most of their responsibilities required under the vaccine immunity agreement they've been using as cover for decades... I don't think anyone who's been paying attention will ever find them trustworthy again. I personally don't even know anyone who'd be willing to give them a chance. And as they're a part of the upcoming WHO-UN attempt to seize worldwide control over all governments through an unspecified future "catastrophic event", defined by themselves of course and without any oversight or recourse if (or should I say," when") they abuse the ability, I don't believe that the FDA even deserves to continue receiving federal funding any longer. I'll mention here that I get most of my information regarding this issue from scientific white papers. There are an infinite number being published all of the time,as researchers are always publishing their data and conclusions, or peer-reviewing some other colleague's work There's so very much information if you just look,. Perhaps the best solution would be to simply de-charter the whole FDA agency and create it anew, but with much stricter checks and restraints upon the 'new' agency,in order that such cavalier treatment of human lives & medical sovereignty cannot ever be attempted again.

Jim Zietlow

The point of this article is to discuss the key laws broken used to implement mandating these illegal injections. Only if the actions and key organizations are identified and challenged is there a chance for change. Otherwise history is likely to reoccur.

B Seidem

Vaccines do not work. A virus has never been seen. Read "Virus Mania", 2020 and get the unvarnished truth. Will never trust gov, health agencies, or doctors again. $$$$$$$ are their god. All that is left is the guillotine.

Sargent Pepper

The pharma phuckers experimented on us with bio weapons with the assistance of gov. Just like they did to their own soldiers 2003. And it’s been going on longer than that. I would say get another Nuremburg trial, but apparently the first one never stuck and some of the worst perpetrators never stood accused.
Complaint.pdf

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