Shell Game? There remains no FDA approved COVID vaccine in the United States
Is Pfizer is using children as legal human shields to get full authorization?
I fact checked the fact checkers and couldn’t believe what I found. Despite the corporate press, Big Pharma, and the federal government telling us otherwise, it is absolutely true that there is no FDA approved COVID-19 vaccine available in the United States today. And there are no plans to make one available any time soon.
I know it’s hard to believe, but it’s 100% true. And this reality hints at an incredible scandal within both Big Pharma and the U.S. Public Health bureaucracy.
On August 23, the FDA granted full approval for a COVID-19 vaccine to Pfizer-BioNtech for a specific product sold under the brand name Comirnaty. The landmark moment — the “full approval” endorsement from the FDA — was heralded by the Biden Administration and countless states, and quickly leveraged to coerce millions into taking the shots. This product, Comirnaty, was fully authorized for the “prevention of COVID-19 disease in individuals 16 years of age and older.”
Yet Comirnaty itself has never made its way into the United States. The fully-approved version is nowhere to be found within our borders.
A separate product, which remains under emergency use authorization (EUA), is the only “Pfizer shot” available in the United States.
Early on, Pfizer and its government allies seemed to have a reasonable explanation for this issue. They claimed that Comirnaty was not yet available because the EUA shots were still lining the shelves, and claimed that the FDA-approved version would be available to all soon.
Now, it’s been over 4 months since full approval, and Comirnaty is still not being distributed.
The FDA has recognized Comirnaty as a “legally distinct” product with “certain differences,” but claims it does not impact safety or effectiveness of the shots. “Fact checkers” leverage the latter point of safety and efficacy to claim that people are still getting access to ingredients akin to the fully approved product.
But here’s the issue: they have yet to explain why people still can’t get Comirnaty, now 128 days after full approval.
And if it is the case that the two products are the exact same thing, the FDA has not explained why they only approved a distinct product named Comirnaty, and not the injection currently being sold under the EUA label. Why won’t the FDA approve the EUA product?
The CDC continues to confirm that Comirnaty is “not orderable at this time.” Moreover, the CDC currently states that “Pfizer does not plan to produce any product with these NDCs (National Drug Codes) and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.”
Now, back to the trillion dollar EUA question.
Is Pfizer refusing to make the fully authorized version available, while continuing to sell an EUA product because doing so could open up Pfizer and BioNTech to legal liability issues?
Pfizer and an HHS spokesperson talked to The Washington Post in a previous “fact check,” and claimed that there’s no additional legal immunity benefits between the EUA product and Comirnaty. However, these entities have never explained why Pfizer and the federal government would go through the trouble of recognizing two legally distinct products.
An EUA fully protects the drugmaker and grants zero legal recourse to the patient. This surefire protection measure was bolstered by the PREP act and other measures implemented to shield COVID companies from liability.
Now, here’s where it all gets very nefarious.
Due to a law passed during the Reagan Administration, in order for drug makers to be granted more robust legal liability protection for their vaccines, they must first secure full approval for the children’s version of their shot. Steve Kirsch has explained this at length last month on his Substack. Additionally, Robert Kennedy Jr mentioned it on a recent podcast with Mikhaila Peterson. I looked into these claims extensively, and they appear accurate. The National Childhood Vaccine Injury Act (NCVIA), which was passed into law in 1986, provides a legal liability shield to drug manufacturers if they receive full authorization for all ages.
Is Pfizer seeking approval for children so that it can protect itself from lawsuits? The company is working with regulators, even clandestinely altering vaccine ingredients (a process that should require them to get full approval for an entirely separate product), in a seeming bid to clear the path to legal indemnity.
Surely, there’s also a monetary incentive in play, but maybe there’s another reason why Pfizer, Moderna, and others are working relentlessly to authorize their products for children, who face near-zero risk from COVID-19, but continue to showcase alarming side effects from the vaccine. A vaccine on the children’s schedule provides a definitive, government-incentivized liability boost.
If Comirnaty becomes available for all ages, that means Pfizer receives an extensive, additional layer of protection.
Is Big Pharma using children as legal human shields for their products?
There is currently no fully authorized COVID-19 vaccine available in the United States today, and this reality has been attacked relentlessly by the corporate press. "Fact checkers" at Newsweek, USA Today, Reuters the Associated Press, and elsewhere peddled false information to cover up this absolute fact.
If you run a Google search on this issue, you will find the aforementioned “fact checks” as evidence that Comirnaty is available, when it is most certainly not available. Nobody in the United States is receiving the legally distinct, fully authorized shot. Is it because that shot makes Big Pharma and corrupt regulators more legally vulnerable than they want to be?
[This piece has been updated to reflect that both Pfizer and the federal government claim that Comirnaty has the same legal protections as the EUA product.
However, there remains no compelling explanation for why there are two distinct products, and why one is being delivered under EUA, and the fully authorized version is not available.]
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