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To: semimojo; Safrguns
"...and there’s no provision that revokes the EUA when alternatives emerge.

Not true, when "approved" alternatives are available.

Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 142 KB) (21 USC 360bbb-3)

Moderna's "Criteria for Issuance of Authorization" -

I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

...

C. There is no adequate, approved, and available alternative to the emergency use of Moderna COVID-19 Vaccine to prevent COVID-19.

Jannsen's "Criteria for Issuance of Authorization" -

I have concluded that the emergency use of the Janssen COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

...

3. There is no adequate, approved, and available alternative to the emergency use of the Janssen COVID‑19 Vaccine to prevent COVID-19.

Emergency Use Authorization of Medical Products and Related Authorities - "FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1)) no longer exist (See "C" for Maderna & "3" for Janssen above), the criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect the public health or safety."

19 posted on 08/27/2021 3:19:30 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: rxsid
“FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1))…”

Exactly. The FDA can withdraw the EUA if they choose to but nothing automatically revokes it when a new drug is approved.

23 posted on 08/27/2021 3:40:18 PM PDT by semimojo
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To: rxsid

Thanks for that... so FDA DOES have means to revoke EUA.

They still have not even talked about it.

Nor have they talked about issuing approval for other manufacturers like they did for Pfizer.

I am of the belief that Pfizer’s “vaccine” is itself STILL UNDER EUA.

This sham of an approval was just to take the political pressure off of themselves.

It’s only intended usage was for public consumption of yet another lie... so we would VOLUNTARILY submit to an EXPERIMENTAL drug.


31 posted on 08/27/2021 4:07:13 PM PDT by Safrguns
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