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John Atkison
@Duende
23 August, 04:00
In response Mr. Deeds to his Publication
Read Page 12 of Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021. Quoting...
X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:
• This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; ...
The Pfizer vaccine hasn't been approved. Approval was given for the COMIRNATY "variant" of the vaccine.
https://www.fda.gov/media/...
X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:
• This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; ...
The Pfizer vaccine hasn't been approved. Approval was given for the COMIRNATY "variant" of the vaccine.
https://www.fda.gov/media/...
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Mare Qay - WWG1WGA!
@Patriot63
23 August, 04:51
In response John Atkison to his Publication
so now they changed the name of it???
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BioNTech Manufacturing GmbH is Pfizer's European (German) partner and helps produce the original Pfizer-BioNTech COVID‑19 vaccine. BioNTech has now been approved to distribute under the EUA their COMIRNATY vaccine, which is the same as the original. Quoting from page 2 of the Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021 document...
"Pfizer-BioNTech COVID‑19 Vaccine 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 can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series."
Since the document has the word "approval" in it, approval being the BLA (biologics licensing application), everyone seems to be misreading that as if the vaccine has been given full FDA approval. It's not approved, only authorized.
"Pfizer-BioNTech COVID‑19 Vaccine 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 can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series."
Since the document has the word "approval" in it, approval being the BLA (biologics licensing application), everyone seems to be misreading that as if the vaccine has been given full FDA approval. It's not approved, only authorized.
05:10 PM - Aug 23, 2021
In response Mare Qay - WWG1WGA! to her Publication
Only people mentioned by Duende in this post can reply
Berry Good
@Berries4all
23 August, 08:03
In response John Atkison to his Publication
This is quite confusing. I read the document, but I don't get it. So "the vaccine" that everyone's been getting is still under EUA, but this new one, "Comirnaty" is fully approved? Is that right?
If so, what IS Comirnaty? Is it the same thing, or somehow different?
If so, what IS Comirnaty? Is it the same thing, or somehow different?
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John Atkison
@Duende
24 August, 11:46
In response Berry Good to his Publication
COMIRNATY is just another name for the Pfizer-BioNTech COVID-19 vaccine. Think of it as a brand name, for example, Plaquenil is a brand name for Hydroychloroquine. There is no "new" vaccine, just a re-branding of the Pfizer vaccine that Pfizer's German partner, BioNTech,will market.
What the FDA approved was the licensing application, the BLA (biologics licensing application), that will allow BioNTech to sell the newly branded, same old formula Pfizer-BioNTech vaccine under the existing EUA. The FDA also extended the EUA.
Linked below is the document explaining what the FDA did. Read the first paragraph on page 2, that's where the approval of the licensing application is located.
Next, read section Y that starts at the bottom of page 11 and continues on page 12. First bullet point is key. Pfizer-BioNTech COVID-19 vaccine is mentioned and as I mentioned before, the COMIRNATY vaccine is the Pfizer-BioNTech COVID-19 vaccine.
https://www.fda.gov/media/...
What the FDA approved was the licensing application, the BLA (biologics licensing application), that will allow BioNTech to sell the newly branded, same old formula Pfizer-BioNTech vaccine under the existing EUA. The FDA also extended the EUA.
Linked below is the document explaining what the FDA did. Read the first paragraph on page 2, that's where the approval of the licensing application is located.
Next, read section Y that starts at the bottom of page 11 and continues on page 12. First bullet point is key. Pfizer-BioNTech COVID-19 vaccine is mentioned and as I mentioned before, the COMIRNATY vaccine is the Pfizer-BioNTech COVID-19 vaccine.
https://www.fda.gov/media/...
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Mare Qay - WWG1WGA!
@Patriot63
23 August, 05:23
In response John Atkison to his Publication
interesting. I did read it but thanks for clarification
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