FDA Fiction — Fictional Approval of COVID-19 Vaccine

As many have correctly noticed, the FDA has not approved any of the COVID-19 vaccines. All currently used Covid-19 vaccines are still under Emergency Use Authorization (EUA). So, the obvious questions are:

  1. Has the FDA approved the BioNTech COMIRNATY vaccine, as alleged?
  2. Why would the FDA approve a vaccine not supplied to the US, instead of approving the equivalent formulation, manufactured and distributed by Pfizer[1], which has been injected in half of the US population, allegedly with enormous success?
  3. Finally, why has the FDA created an artificial legal distinction[2] between batches of the same product, manufactured at different plants?

The FDA Approval Letter in the question is dated by August 23 and is signed by two directors of CBER offices. One of those directors is Marion Gruber, PhD, who has announced her future resignation, due to the CDC’s attempts to force an approval of a COVID-19 vaccine.

The first thing that we notice in the letter is that it lacks the language “We have approved your BLA for <product description> effective <date>”, typically appearing at the beginning of such letters[3]. BLA stands for Biologics License Application. This letter does contain a few sentences authorizing BioNTech to manufacture a COVID-19 Vaccine and approving certain ways and undisclosed locations of manufacturing. It also approves labeling with the name COMIRNATY. This said, such form is used sometimes and is considered as an approval.

The next important fact is that the alleged Approval Letter actually prohibits distribution of the drug named in it:

“Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).”

This language is not unusual in such approval letters. A company receiving such an approval letter from FDA/CBER considers the drug approved and frequently issues a triumphant press release.

But this case is different. There is already a surplus of Pfizer’s product in the US[4], its manufacturing continues, and its EUA is re-issued on the same day. BioNTech has no intent to distribute COMIRNATY in the US, and probably has no right to do so under its agreement with Pfizer. Therefore, it is unlikely BioNTech would submit to CBER the requested samples and “protocols showing results of all applicable tests”. Pfizer and BioNtech have barely announced the alleged FDA approval in a joint press-release.

The “approval” is incomplete. Each side must take at least one more step to complete the process – BioNTech must ship samples and test results and CBER Director must send a notification of release after that. Neither party is interested in taking these last steps.

This answers our first question as to COMIRNATY being truly approved. No, it is not. The FDA approval letter is a fictitious document.

The answer to the first question resolves two others. They issued a fictitious approval letter because they do not want to bear the consequences of a real one. A real approval would be in violation of relevant rules and guidelines and would approve a vaccine which targets the extinct virus variant (or serotype), is harmful for most targeted recipients. Pfizer and the CBER wanted to put as much distance as possible between themselves and this approval.

The fictitious approval letter is only one part of the deception. The other part is the August 23 EUA, falsely claiming that the FDA has approved a formulation equivalent to Pfizer’s vaccine. Pfizer was then allowed to repeat this lie in its marketing materials. This EUA is signed by the FDA Chief Scientist Denise Hinton and promoted by the FDA acting commissioner Janet Woodcock.

Of course, such deception would be unimaginable without the support from Big Tech and Fake News. They claim or insinuate that the Pfizer vaccine is approved by the FDA, and silence those who oppose this lie.

This fictitious approval has been granted with hardly any evidence in its favor (“safety and efficacy findings … up to 6 months of follow-up“) and disregarding a lot of evidence against it. The science is out of the scope of this article, but the letter brazenly states: “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues…”. Clinicians and scientists outside Pfizer and BioNTech raised a lot of concerns and issues before the FDA. See, for example, the Citizen Petition (July 23, 2021) from Coalition Advocating for Adequately Licensed Medicines (CAALM). Also, read Does the FDA think these data justify the first full approval of a covid-19 vaccine? by Peter Doshi, a Senior Editor of the British Medical Journal.

BioNTech filed a BLA on May 18. The FDA announced granting it Priority Review on July 16. The alleged approval came six weeks later. What was the rush if the same vaccine was manufactured and distributed without restrictions under the EUA?

There are also lesser irregularities in the CBER letter. The letter is addressed to Amit Patel of BioNTech, but the address is that of Pfizer in New York. All other pages have headers with the name Elisa Harkins of Pfizer. Ms. Harkins was named on the EUAs. This is either a clever attempt to confuse readers, or sloppiness, suggesting that the letter was not proofread and was likely made in irregular ways. The manufacturing locations are redacted out, although BioNTech publishes the locations of its plants and invites journalists to tour them. Of notice, this letter was issued on August 23, when the public’s attention was on the Afghanistan disaster.

[1] Pfizer-BioNTech COVID19 Vaccine, per May 10 EUA Expansion

[2]The products are legally distinct with certain differences that do not impact safety or effectiveness”, per VACCINE INFORMATION FACT SHEET, rev. 2021-08-23

[3] Examples 1, 2, 3, 4.

[4]There remains, however, a significant amount of PfizerBioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization,” – the re-issued and updated EUA for Pfizer, dated by August 23.

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