Two days ago, the US mass media was awash with the news that the Pfizer vaccine for COVID-19 has been FDA approved. This means the military, government agencies, and private companies can now mandate the Pfizer vaccine.
In reality, there is a big difference. What is approved is another brand of the Pfizer COVID-19 vaccine called Comirnaty. The following are snippets from the FDA approval letter. (emphasis added)
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.
Only the Comirnaty is fully approved. The Pfizer Biontech is still under EUA.
The contents of the Comirnaty and the Pfizer Biontech vaccine are similar and can be used interchangeably.
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns.
The products are legally distinct with certain differences that do not impact safety or effectiveness.
Notice the words legally distinct? It means that since Comirnaty is approved, Comirnaty does not shield Pfizer from lawsuits from adverse reactions since the FDA now approves it.
However, the COVID-19 vaccine with the Pfizer Biontech label is still under Emergency Use Authorization. They are under the 2005 Public Readiness and Preparedness Act. This means, if someone suffers a severe adverse reaction or even death after Pfizer COVID-19 vaccination, they cannot sue Pfizer.
Here is a tip from Children’s Health Defense,
Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product.
If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.
If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.
India Rejected Comirnaty in February 2021
Comirnaty has been around since February 2021. In fact, India’s COVID-19 Subject Expert Committee (SEC) recommended against its authorization.
After reviewing data presented by Pfizer at an SEC meeting on 3 February, the committee did not recommend that an EUA be granted, citing serious adverse events including anaphylaxis and palsy as well as the companies’ lack of safety and immunogenicity studies in the Indian population.
It gets crazier every day.
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