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FDA approves Comirnaty COVID-19 Vaccine

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There is a rumor going around that the approval is for the name change. After looking at the Approval Letter from the FDA’s Comirnaty and Pfizer-BioNTech COVID-19 Vaccine page, it does appear to be the licensing letter for the inoculation.  This is apparent in the terms used, which are different from those in an Emergency Use Authorization.  Compare the language used in the approval letter with those issued with the EUAs.  It looks like there are still some final details that are being worked out; otherwise, it appears that the Comirnaty inoculation is now fully approved for sale.  As of yet, the Comirnaty jab is not available in the US.  The Comirnaty/Pfizer-BioNTech Fact Sheet for Healthcare Providers Administering Vaccine clearly states that pre-authorization Pfizer-BioNTech vaccine and the Comirnaty vaccine are equivalent.  However, a recent judicial ruling claims that there is no legal equivalency, and they are not interchangeable.

  • Food & Drug Administration
    October 20, 2021. “Fact Sheet for Healthcare Providers Administering Vaccine [Pfizer-BioNTech].” US Food & Drug Administration. https://www.fda.gov/media/144413/download.
    Food & Drug Administration.
    This document has instructions for healthcare providers who are administering the vaccines.

However, another letter from August 23, 2021, admits that there are differences between the Pfizer-BioNTech vaccine and the Comirnaty vaccine, though they are not spelled out.

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.

The FDA is saying that the products are legally distinct.  They are not the same.  A case can be made that if the recipient did not receive a jab that did came out of a vial with a Comirnaty label, they did not receive the approved vaccine.

The Approval Letter ends thus:

POST APPROVAL FEEDBACK MEETING

New biological products qualify for a post approval feedback meeting. Such meetings are used to discuss the quality of the application and to evaluate the communication process during drug development and marketing application review. The purpose is to learn from successful aspects of the review process and to identify areas that could benefit from improvement. If you would like to have such a meeting with us, please contact the Regulatory Project Manager for this application.

So, if we have concerns, we have been invited to share them.

Meanwhile, the trials have NOT been completed.  Furthermore, the trial has already been unblinded and is thus no longer a randomized control trial.  The Phase III trial is not scheduled for completion until May 2, 2023.  In other words, Comirnaty was approved prior to completion of required trials.

Page 14 of CCCA report: Pfizer did not follow established protocols

I believe that Dr. Jane Ruby in the interview below has properly assessed the situation.  In discussing the proposed Comirnaty package insert, she said:

This document is so paltry, I have to tell you, in my estimation, the FDA itself has violated its own federal [regulations].  In that situation, to me, this is an illegal approval, and the FDA is committing crimes.

— Dr. Jane Ruby

Compare the proposed Comirnaty package insert to inserts for other products, and the differences in quality of content become obvious.

Dr. Ruby then goes on to list some 20 alleged crimes that were committed just in the package insert.

Dr. Ruby offers a ray of hope: 50% of those inoculated received a placebo.

The ingredients list is due on September 7.

They had to ignore a whole lot to approve the inoculation.  This is not about health.

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