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Regulatory Watchcat''s Comments posted to the public docket re: Pfizer EUA

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04-Dec-2020 15:35

Julie Omohundro

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Julie Omohundro

05-Dec-2020 17:12

You would think. And yet FDA has made other vaccines available via expanded access. Perhaps "it depends." :)

Michael Wienholt

05-Dec-2020 08:43

Very well researched and articulated. Regarding expanded access, according to the FDA website:

Expanded access may be appropriate when all the following apply:

Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Patient enrollment in a clinical trial is not possible.
Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

A vaccine authorized for emergency use would not meet the first criterion since a vaccine is preventative.