Pfizer Admits That “There Are No Approved COVID-19 Vaccines”

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The FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years old. The FDA announced on October 29, 2021:

 

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. 1


Emergency use authorization (EUA) is a distinct status. It is not the same as FDA approval. The fact sheet for the Pfizer-BioNTech COVID-19 Vaccine explains that it is the only COVID-19 vaccine that is authorized by the FDA for emergency use for children 5 through 11 years of age and that “there are no approved COVID-19 vaccines.” 2


The gravamen of the EUA standard is that the known and potential benefits of the COVID-19 vaccines, when used to prevent COVID-19, outweigh their known and potential risks. The COVID-19 vaccines have not been demonstrated to be safe or effective by the FDA. The COVID-19 vaccines are authorized for use and are being monitored for safety and effectiveness. But they are not approved. EUA vaccines are unapproved experimental vaccines.


You might think it is odd that Pfizer-BioNTech would say in its vaccine fact sheet that “there are no approved COVID-19 vaccines” 3 when the FDA has previously approved COMIRNATY (COVID-19 Vaccine, mRNA). But please notice that there are two vaccines discussed in the August FDA letter approving COMIRNATY. The two vaccines have two distinct legal identities. The only one that is available for use in the U.S. remains an unapproved vaccine under an EUA. The FDA pointed out in a footnote in the authorization letter that the two vaccines are not identical. “The products are legally distinct with certain differences that do not impact safety or effectiveness.” The two distinct vaccines are:

 

1) COMIRNATY (COVID-19 Vaccine, mRNA) and

 

2) Pfizer-BioNTech COVID-19 vaccine.


The Pfizer-BioNTech COVID-19 vaccine remains unapproved and under its original emergency use authorization (EUA). At the same time, the FDA has approved COMIRNATY (COVID-19 Vaccine, mRNA). 4


Vaccines can be authorized for use in an emergency by the FDA while undergoing experimental trials. Authorization for use in an emergency is not the same as approval. Such investigational vaccines are not approved by the FDA. COVID-19 vaccines are “investigational vaccines” authorized under an emergency use authorization (EUA). An investigational vaccine is, by definition, an experimental vaccine. Investigational vaccines being used under an EUA are “still in the testing and evaluation phase and are not licensed for use in the general public.” 5


The FDA states that “Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.” 6 The FDA further explains that “[t]he [approved] vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.” 7 But keep in mind that, while the two vaccines have the same formula, they are not identical. They have “certain differences,” which were not specified; and they are “legally distinct.”


Thus, we have two substantially similar vaccines, one being administered under an EUA and another under FDA approval. The problem is that the approved vaccine, COMIRNATY (COVID-19 Vaccine, mRNA), is now manufactured in Germany by Pfizer and BioNTech, a company that works in partnership with Pfizer. 8 A footnote in the letter states:

 

Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. 9


That means that it is not yet available in the U.S. Thus, all of the COVID-19 vaccines now being administered in the U.S. under the Pfizer-BioNTech partnership are being administered under the EUA. The effect of that is that the public thinks that they are getting an approved vaccine under the legal standards for an approved vaccine, but in reality, they are receiving an EUA vaccine that comes with all of the risks of an EUA vaccine.


The Pfizer-BioNTech statement in its fact sheet for its COVID-19 vaccine for children that “there are no approved COVID-19 vaccines” 10 was not a misstatement. Pfizer specifically mentioned COMIRNATY in the fact sheet. The statement seems to be an acknowledgment that the approval of COMIRNATY (COVID-19 Vaccine, mRNA) was a bait and switch scheme to trick the public. Ffizer admits, that for all practical purposes, in the United States, “there are no approved COVID-19 vaccines.” 11


The risks of an EUA vaccine are discussed in greater detail at: The FDA Approval of the Pfizer-BioNTech COVID-19 Vaccine Is Not What it Seems




Endnotes

1

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age, FDA, October 29, 2021, https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age.

2

Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-biontech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (Covid-19) for Use in Individuals 5 Through 11 Years of Age, October 29, 2021, https://www.fda.gov/media/153717/download.

3

Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-biontech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (Covid-19) for Use in Individuals 5 Through 11 Years of Age, October 29, 2021, https://www.fda.gov/media/153717/download.

4

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, August 23, 2021, https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine.

5

Investigational vaccine, https://www.cdc.gov/vaccines/terms/glossary.html (last visited on July 31, 2021).

6

FDA Approves First COVID-19 Vaccine, FDA, August 23, 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

7

FDA Approves First COVID-19 Vaccine, FDA, August 23, 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

8

COVID-19 Vaccine Explainer, 18 January 2021, https://www.who.int/publications/m/item/comirnaty-covid-19-mrna-vaccine. See also Comirnaty, Summary of Product Characteristics, https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf.

9

Denise M. Hinton, Chief Scientist, FDA, Letter to Pfizer Inc., Attention: Ms. Elisa Harkins, August 23, 2021, https://www.fda.gov/media/150386/download.

10

Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-biontech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (Covid-19) for Use in Individuals 5 Through 11 Years of Age, October 29, 2021, https://www.fda.gov/media/153717/download.

11

Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-biontech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (Covid-19) for Use in Individuals 5 Through 11 Years of Age, October 29, 2021, https://www.fda.gov/media/153717/download.


The FDA Approval of the Pfizer-BioNTech COVID-19 Vaccine Is Not What it Seems

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