Here are two articles from Children's Health Defense about the FDA's approval of licensure for the Pfizer Covid-19 vaccine on August 23, 2021.
Article 1 from 8/24/21:
2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
The FDA approved licensure of the Pfizer Comirnaty vaccine, but this vaccine under this brand name is not yet available in the US. At the same time the FDA extended Emergency Use Authorization for the Pfizer BioNTech vaccine, which is the one currently available in the US.
Article 2 from 9/7/21:
Children’s Health Defense Sues FDA Over Approval of Pfizer Comirnaty Vaccine
The lawsuit, filed Aug. 31, 2021 alleges the FDA violated federal law when the agency simultaneously licensed Pfizer’s Comirnaty COVID vaccine and extended Emergency Use Authorization for the Pfizer-BioNTech vaccine.
Here is the actual FDA Letter to Pfizer, an excerpt from page 2, and footnote #8 on p. 2:
According to the lawsuit, the FDA violated federal law when it simultaneously licensed Pfizer’s “Comirnaty” vaccine and extended Pfizer’s EUA for its vaccine that has the “same formulation” and that “can be used interchangeably,” according to the FDA.
The law on “authorization for medical products for use in emergencies” requires the EUA designation be used only when “there is no adequate, approved and available alternative to the product for diagnosing, preventing or treating such disease or condition.”
The lawsuit alleges once the FDA approved and licensed Pfizer’s Comirnaty vaccine, there was no further basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine that Pfizer acknowledges has the “same formulation” and is “interchangeable.”
The updated PFIZER FACT SHEET states the differences clearly:
