Report 14: Were We Lied to by the FDA?

What’s the difference between Pfizer’s FDA approved COMIRNATY and the emergency use authorized “vaccine?”

Only the law, not science, says the FDA.

Were we lied to by the U.S. Food and Drug Administration (FDA) and the media when they told us that, if we received the Pfizer “vaccine” after August 23, 2021, we, along with our children, would receive the FDA-approved COMIRNATY?  Unfortunately, the answer is a clear “yes,” and the FDA itself tells us so.

On August 23, 2021, the FDA issued two letters to Pfizer, Inc.  One letter was addressed to Pfizer at its office in Collegeville, Pennsylvania, and concerned the FDA’s extension of the emergency use authorization (EUA) of “Pfizer-BioNTech COVID-19 Vaccine,” i.e. the experimental mRNA gene therapy referred to in clinical trials (which are ongoing) as BNT162b2.

The other letter was addressed to both BioNTech Manufacturing GmbH (BNT) and to Pfizer, Inc., at an address in New York, New York, and concerned the FDA’s approval of Pfizer/BNT’s “COVID-19 Vaccine, mRNA.” This product was licensed, or “approved,” by the FDA to be made publicly available for injection into humans 16 years of age and older under the proprietary name COMIRNATY. 

We learn from the FDA’s August 23, 2021 letter regarding the EUA-authorization of “Pfizer-BioNTech COVID-19 Vaccine” that this “vaccine” was first granted EUA by the FDA on December 11, 2020. The FDA reissued the EUA an additional five times prior to August 23, 2021. The last EUA prior to that date was on August 12, 2021.  (EUA or approval letters from the FDA to Pfizer/BNT after August 23, 2021, typically pertain to “boosters.”)

On August 23, 2021, the FDA concluded that revisions to the August 12, 2021, EUA were “appropriate to protect the public health or safety.”  Tellingly, the revisions and the reissuance of the EUA coincided with the FDA’s approval of COMIRNATY, also on August 23, 2021. In the EUA letter, the FDA reissued:

“The August 12, 2021, letter of authorization in its entirety with revisions incorporated to clarify that 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 [emphasis added].”

“BLA” means “Biologics License Application.”  The “approved BLA” is an express reference to the FDA’s approval of COMIRNATY in the August 23, 2021, letter to both BioNTech and Pfizer.

What the FDA is saying is that, pursuant to the EUA of the “Pfizer-BioNTech COVID-19 Vaccine,” which does not have FDA approval, Pfizer is authorized to administer COMIRNATY for uses and purposes for which the FDA did not approve the use of COMIRNATY.  One could reasonably ask:  Is there any difference between these two products to warrant FDA approval of COMIRNATY?

What’s The Difference?  It’s The Law, Not Science and Medicine.

The FDA itself answers this question in the letter addressed only to Pfizer regarding the EUA-authorization of “Pfizer-BioNTech COVID-19 Vaccine.”  In that letter, the FDA makes clear that there is no scientific difference between the EUA-authorized “vaccine” and the approved COMIRNATY “vaccine.”  Rather, any difference is a matter of law, not science.  This is what lawyers call a legal fiction.

From that letter we learn that:

“Pfizer-BioNTech COVID-19 Vaccine [the EUA product] contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and [COMIRNATY] can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.” 

This quote ends with reference to footnote 8, which reads:

“The licensed vaccine [COMIRNATY] 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.”  ((https://www.armstrongeconomics.com/wp-content/uploads/2021/08/FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2.pdf, p. 2.)

There you have it. The FDA EUA-authorized product and the FDA-approved COMINARTY are scientifically identical and can be used, medically-speaking, interchangeably; but they are “legally distinct.” This legal distinction is based upon an alleged, and fraudulent, ongoing health emergency and the statutory law, rules and regulations applicable to the FDA when such an emergency – real, imagined or trumped-up – is declared to exist by the people and agencies in which the public is expected to dutifully repose trust and confidence.

Unconscionably, these so-called laws have been applied by the FDA to authorize use of COMIRNATY for children aged 12-15, when COMIRNATY has not been licensed/approved for that age group. Given that there is admittedly no scientific and medical difference between these two products, there is no rationale and defensible justification for the FDA to authorize the use of COMIRNATY when it has not approved the use of COMIRNATY for children aged 12-15. 

Why Have Concerns About Safety And Effectiveness For Children?  The FDA Isn’t Concerned.  Or is it?

In the FDA’s August 23, 2021, letter to Pfizer/BNT granting a license/approval for COMIRNATY in the USA, the FDA approved the manufacture of COMIRNATY to be administered to humans 16 years of age and older.  (The FDA set a number of conditions to this approval which have yet to be met and will take years to do so, if at all.)  However, Pfizer/BNT’s BLA (Biologics License Application) also sought a license to administer COMIRNATY to 12–15-year-old children, as well as to humans 16 years of age and older.  Notably, the FDA advised Pfizer/BTN that it had concerns about the pediatric use of COMIRNATY in children ages 12-15 because Pfizer had not fulfilled the pediatric study requirements for this age group.  In part, for that reason, as well as others, the FDA did not license/approve COMIRNATY for the 12-15 age group.  Instead, it required Pfizer/BNT to conduct a number of studies and set timetables to do so.  Many of the dates in the timetables do not expire until 2025, 2026 or 2027. Meanwhile, employing an expedient legal fiction, the FDA has authorized the use of the EUA product on children age 12-15 when it does not (and should not) approve the use of COMIRNATY for this age-group (or for any age group).  

Unsurprisingly, the FDA did find that Pfizer/BTN had fulfilled the pediatric study requirements for the 16-17 age group.  How much weight, if any, should the public put on the FDA’s finding?  Interestingly, regarding the 16 and older age group, the FDA stated:

“We did not refer your application to the Vaccines and Related Biological Products Advisory Commission because our review of the information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefitted from an advisory committee discussion.”  (https://www.fda.gov/media/151710/download), p. 2.)

No concerns.  Oh, really?  The clinical study design and trial results, as well as the safety, efficacy and medical necessity of the Pfizer products (not to mention the other “vaccines” for “COVID-19 disease”), have been reasonably and effectively challenged by many qualified medical and other experts, many of whom also question the FDA’s decision to bypass the Vaccines and Related Biological Products Advisory Commission.  It is reasonable to conclude that the FDA and Pfizer did not want such a review, as it would have shed light on and called into question, the FDA’s conclusion that these products are safe, effective and medically-necessary.

On a related note, after the FDA issued the August 23, 2021, letters many media outlets falsely claimed that the FDA had licensed and approved both Pfizer mRNA products.  To that end, these media sources intentionally and recklessly gave the impression to the public that everyone who received the Pfizer injection would be administered only the “approved” COMIRNATY.  That was not, and is not, true.  Consequently, in the opinion of this writer, any discussions about whether COMIRNATY is available and being administered in the United States are rendered moot and non-productive. What difference does it make when the only distinction between the two is artificial and expedient? The distinction is to be found only in the law and not the science.  Indeed, to again quote the FDA, “the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns.”

While the FDA expressed no concerns about administering COMIRNATY to humans 16 years of age and older, it expressed concerns about administering COMIRNATY to children aged 12-15. Yet, incredibly, inconsistently and dangerously, despite the EUA-authorized product and COMIRNATY being scientifically identical and interchangeable, the concerns the FDA had about administering COMIRNATY to children aged 12-15 were intentionally and reprehensively tossed to the way-side when the FDA gave EUA-authorization to Pfizer to administer COMIRNATY to children age 12-15 under the pretext of an alleged health emergency.  There’s that legal distinction, actually legal fiction, at work in real-life, with its severe and irreparable injurious and deadly consequences.

The so-called legal distinction, but without any scientific/medical difference, between the EUA-authorized product on the one hand, and the licensed/approved COMIRNATY on the other hand, must come as little or no consolation to parents whose children received COMIRNATY and to those who have been administered COMIRNATY and/or the EUA-authorized product and are suffering, or will suffer, adverse events as a direct result — regardless of their age.

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Mr. Looney is a civil trial and appellate attorney with 42 years of experience, concentrating on complex matters. Mr. Looney is licensed in New Mexico and practices in all its courts, as well as the United States District Court for the District of New Mexico, the Tenth Circuit Court of Appeals, the US Tax Court and the US Supreme Court. Mr. Looney served in the U.S. Army as an infantryman from 1970-1972, assigned to the 82nd Arbrn. Div.

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