COVID Counterpunch

The FDA’s Dangerous Shell Game

On Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the BioNTech Comirnaty vaccine, known up to this point as Pfizer-BioNTech.

A jubilant media wasted no time reporting that legal impediments to vaccine mandates would now be a thing of the past, and the President immediately urged private companies to mandate vaccines.

But there are aspects to the FDA approval that are confusing at the very least, deceptive at worst.

First, despite the licensure of the Comirnaty vaccine, the FDA acknowledges that “there is not sufficient approved vaccine available for distribution” (page 5, footnote 9). In other words, they licensed it, but you won’t be getting it anytime soon.

Secondly, the FDA explains that because there is an insufficient supply of Comirnaty, and a “significant amount” (page 12, AA) of Pfizer-BioNTech, they will extend the emergency use authorization (EUA) for Pfizer-BioNTech even though they’ve licensed Comirnaty.

According to the FDA, licensing Comirnaty and maintaining an EUA for Pfizer-BioNTech will make the products able to be used “interchangeably,” but they will be “legally distinct” (page 2, footnote 8).

“Legally distinct” is the most important term here, because there is a huge legal difference between products approved under an EUA compared with those licensed by the FDA.

EUA-approved COVID vaccines are considered experimental under U.S. law, and mandating an experimental product is not only a violation of the Nuremberg Code, but also the principles governing informed consent and the “option to accept or refuse” an experimental product outlined in 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III).

Because vaccines under EUA are not licensed by the FDA, vaccine manufacturers, distributors, providers, and government officials are completely immune from injury liability under the 2005 Public Readiness and Preparedness Act.

The only way an injured party can sue for harms caused by an EUA vaccine is if they are able to prove willful misconduct, and if the U.S. government has also brought an action against those responsible. No such lawsuit has yet succeeded.

On the other hand, FDA-licensed vaccines have no such liability shield, meaning that vaccine manufacturers, distributors, providers, and government officials can be sued for any injuries incurred.

Since it has been licensed by the FDA and is likely to be widely mandated, the Comirnaty vaccine has no liability shield. A product with that name on the label is subject to the same liability laws as other U.S. products.

This sounds fine until you remember that the FDA has already told us there is no available supply of Comirnaty.

The FDA has essentially created a “legal” mechanism for vaccine mandates that shields Pharma companies from liability while allowing Pfizer to unload its vaccine surplus under false legal pretenses.

With only the renamed Pfizer vaccine licensed, Americans will assume that vaccine mandates are lawful and that they have no choice but to comply, even though only the EUA-authorized vaccines will be available to them.

Americans can now be tricked into giving up their right to refuse an experimental product, and no one will have any liability for their injuries.

So what can we do?

If you are faced with a mandate for a vaccine, ask to see the bottle or packaging. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech”, “Moderna”, or “Johnson and Johnson” (marketed as “Janssen”), it’s an experimental product with an EUA, and under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), you have the right to refuse.

The FDA is playing a dangerous and deceptive game.

But we don’t have to play along.

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