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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/...
04:00 PM - Aug 23, 2021
In response Mr. Deeds to his Publication
Only people mentioned by Duende in this post can reply
Shannon Harding
@Believer101
23 August, 10:28
In response John Atkison to his Publication
They are spreading the lie that the vax has been fully FDA approved! It's been reported as such on all the fake news stations.
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John Atkison
@Duende
24 August, 11:57
In response Shannon Harding to his Publication
Yeah, I know.
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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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John Atkison
@Duende
23 August, 05:10
In response Mare Qay - WWG1WGA! to her Publication
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.
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