FDA extends EUA

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Well-known member
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing 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.

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Well-known member
approved and not approved
if you get the EUA (not approved) you can't sue ,
but you can't get the approved one.

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Well-known member
Children's Health Defense
Tue, September 7, 2021, 8:23 AM·2 min read

Washington, DC, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Last week, Children’s Health Defense (CHD) filed suit in Tennessee federal court against the U.S. Food and Drug Administration (FDA) and its acting director Janet Woodcock for their deceptive, rushed licensure of Pfizer’s Comirnaty vaccine. CHD argues that the licensure was a classic “bait and switch,” allowing Pfizer, the Administration, the military and employers to exhort people to take “licensed” vaccines when in fact the vaccines available continue to be the Pfizer-BioNTech Emergency Use Authorization (EUA) vaccines.

The lawsuit alleges that the FDA’s actions are arbitrary and capricious. Under federal law, if the FDA licenses a product for the same precise purpose as an existing emergency use authorization product, it must withdraw the EUA. Yet here, the FDA is allowing Pfizer to have “interchangeable” vaccines, Comirnaty and Pfizer-BioNTech, on the market at the same time for the same indication of people aged 16 and up, while suggesting that the vaccines are “legally distinct.” CHD asserts that the FDA has violated the law.
 
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