Thursday, August 26, 2021

The FDA did NOT grant full approval to the Pfizer shots

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing.

The first one was a letter of BLA approval, and the second was a letter of EUA extension to COMIRNATY. The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots.

This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.

The EUA extension letter extends the term of the EUA for the current drug and authorizes the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter.

Dr. Meryl Nass, M.D. found the truths that the FDA buried in the blather of these letters and offers a theory about why it was done this way.

Of great concern, considering the factual content of the FDA EUA letters to Pfizer, is the breezy way the press release on the FDA website repeatedly uses the words "Approve" and "Approval" in reference to the Pfizer drug.

https://www.americanthinker.com/blog/2021/08/the_fda_did_not_grant_full_approval_to_the_pfizer_shots.html 

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