The FDA – Pfizer Fiasco

There has been a great deal of confusion, misrepresentation and outright lying about the current status of the mRNA vaccines. Here is the official status from the official documents. In the following analysis, emphasis in quotations is mine.

The Moderna mRNA-1273 Vaccine

In a letter^[1] to Carlota Vinals of Moderna TX, Inc., dated August 12, 2021, Denise M. Hinton, Chief Scientist, Food and Drug Administration, authorized the continuance of the Emergency Use Authorization (EUA) for the Moderna mRNA-1273 vaccine.

I am authorizing the emergency use of Moderna COVID-19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization.

FDA letter^[1]

The Pfizer-BioNTech Vaccine BNT162b2

In a letter[2] to Elisa Harkins of Pfizer Inc., dated August 23, 2021, Hinton reissued the EUA for the Pfizer-BioNTech BNT162b2 vaccine which had been issued a continuance in a letter on August 12 (letter mat not be available).

FDA reissued the letter of authorization on: December 23, 2020,3 February 25, 2021,4 May 10, 2021, 5 June 25, 2021,6 and August 12, 2021.

FDA letter^[2]

In the same letter, Hinton notes that the FDA “approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine“. Note that Pfizer did not apply for and was not granted this approval.

The BioNTech Vaccine, Comirnaty

In a letter^[3] to BioNTech but Amit Patel of Pfizer (the relationship is not identified), dated August 23, 2021, Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, and Marion F. Gruber, Director, Office of Vaccines Research and Review issued a licence

under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.

Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, … [for use] in individuals 16 years of age and older.

FDA letter^[3]

The phrase “interstate commerce” is used for products receiving full use authorization.

Hinton notes that:

COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.

FDA letter^[2]

In its application, BioNTech apparently applied for full pediatric use. The FDA deferred on this aspect of use:

We are deferring submission of your pediatric studies for ages younger than 16 years for this application because this product is ready for approval for use in individuals 16 years of age and older, and the pediatric studies for younger ages have not been completed.

FDA letter^[3]

The letter outlines three separate studies for three age ranges 12-15 years, 6 months – <12 years and < 6 months. A Final Report Submission is expected by October 31, 2024. So they do not have approval for using Comirnaty on persons under 16 years.

Returning to Hinton’s letter of the 23rd, at the same time as they granted approval for the use of Comirnaty for individuals 16 years of age and older, they extended the EUA to authorize the use of Comirnaty for the 12 – 15 year age range (Note: the Pfizer EUA had been extended to cover this age range in a letter of May 10^[5]):

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.

FDA letter^[2]

On August 23, FDA released this statement:

COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

FDA^[4]

Summary

The existing Pfizer-BioNTech Vaccine BNT162b2 covered by successive EUAs is the same product as the fully approved BioNTech (Pfizer) Comirnaty vaccine. The differences will be different packaging and marketing strategies, and significantly, different liability coverage at present. The Comirnaty vaccine is not licensed for use against 12-15-yearolds but can and will be used on this group under the existing BNT162b2 EUA.

Although Comirnaty is not currently available, the delay is primarily administrative: packaging, instructional use materials and legal issues.

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What follows is an interview with Dr. Chris Martenson who deciphers the FDA moves in the context of the use of the vaccines and their effects. He describes data inadequacies of the Pfizer disclosures. He also discusses adverse effects such as female fertility issues in depth. As well he touches on other themes that we have written of recently such as the need to form communities of support.

Discussion

The Pfizer and Moderna phase III trials were constructed as double-blind studies in which neither the participants nor the experimenters know who is receiving the vaccine and who is receiving a placebo – the control group. This procedure is utilized to prevent bias in research results.

In January of 2021, the companies offered the vaccine to the control group participants^[6]. This has invalidated the phase three studies, although the trials continue. The results, however, will not be meaningful in terms of assessing long-term adverse effects.

In the past, the FDA required completed phase III studies for any new product to be marketed and probably still does, except for these vaccines. That there will be no valid phase III studies should prevent the vaccines from ever being approved for general use. But in this era where medicine is politicized, approval will go ahead without any longitudinal studies, and this for experimental products that are a technology never used before for their current application.

The FDA should lose all credibility for their bizarre decision.

References

1. Hinton DM. FDA Letter to Moderna. FDA. August 12, 2021. PDF.
2. Hinton DM. FDA Final Letter to Pfizer. FDA. August 23, 2021. PDF.
3. Malarkey MA and Gruber MF. FDA Liscencing Letter to BioNTech. FDA. August 23, 2021. PDF.
4. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. FDA. August 23, 2021.
5. Hinton DM. FDA Letter to Pfizer. FDA. May 10, 2021. PDF.
6. Harris R. Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized. NPR. February 19, 20215:0.

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