The FDA did NOT grant full approval to the Pfizer

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August 26, 2021

By Carl Schwitzer

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.

There's just one problem.

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. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.

The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) 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 (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.

The mRNA gene therapy shots are still experimental. Mandating them is still wrong — by a wide variety of ethical standards.

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. The drug-manufacturers were granted immunity from liability for the drugs produced under the EUAs. The granting of the license re-applies the customary liability for injury and death caused by the product. Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the "approval," while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the unlicensed doses on the shelves and in the manufacturing pipeline that will be administered first. The licensed version will not arrive on shelves or be jabbed into arms for many months to come.

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. If only there were a word for intentionally saying things to the public that do not match reality...

COMIRNATY seems like an unusual name for anything, much less a cutting-edge-technology gene therapy. Out of idle curiosity, I ran the name through an anagram solver. For a result, it gave TIROMANCY, which is divination or prophecy by examining how curds form during the coagulation of cheese. How apropos. That's something I'm willing to try for forecasting the results of the next election!
By Carl Schwitzer

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.

There's just one problem.

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. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.

The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) 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 (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.

The mRNA gene therapy shots are still experimental. Mandating them is still wrong — by a wide variety of ethical standards.

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. The drug-manufacturers were granted immunity from liability for the drugs produced under the EUAs. The granting of the license re-applies the customary liability for injury and death caused by the product. Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the "approval," while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the unlicensed doses on the shelves and in the manufacturing pipeline that will be administered first. The licensed version will not arrive on shelves or be jabbed into arms for many months to come.

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. If only there were a word for intentionally saying things to the public that do not match reality...

COMIRNATY seems like an unusual name for anything, much less a cutting-edge-technology gene therapy. Out of idle curiosity, I ran the name through an anagram solver. For a result, it gave TIROMANCY, which is divination or prophecy by examining how curds form during the coagulation of cheese. How apropos. That's something I'm willing to try for forecasting the results of the next election!

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