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Date Posted: Wednesday, April26, 07:47:am
Author: a Bigger bullyfoot
Subject: Re: mayor bullyfoot...
In reply to: Insecurity 's message, "Re: mayor bullyfoot..." on Tuesday, April25, 10:52:pm

Follow the "psy-ence"...

April 18, 2023
Linda Wastila
Coalition Advocating for Adequately Labeled Medicines (CAALM)
220 Arch Street
Baltimore, MD 21201
Sent via email to: lsimoniw@rx.umaryland.edu
RE: Citizen Petition (Docket Number: FDA-2023-P-0360)
"Dear CAALM:
This letter responds to the citizen petition (the Petition) dated January 31, 2023 that you (Petitioner) submitted to the Food and Drug Administration (FDA, the Agency, we) requesting that FDA “require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine, and Moderna COVID-19 Vaccine (collectively, ‘Pfizer and Moderna COVID-19 vaccines’) amend current product labeling”1 “for all authorized or approved indications and populations”2 to: ..."

"It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission. A vaccine can meet the licensure standard if the vaccine’s benefits of protecting against disease outweigh the vaccine’s risks for the licensed use. There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.48 Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission. To that end, there is no requirement that the clinical trials supporting a vaccine’s licensure or authorization be designed to determine whether the vaccine prevents infection of a pathogen or transmission of that pathogen to others. In addition, with respect to the discussion of clinical studies in prescription drug labeling, FDA’s regulations require that the clinical studies ..."

https://s3.documentcloud.org/documents/23786932/fda-letter-on-covid-19-vaccine-labeling.pdf (page eleven, last paragrapgh)
https://www.documentcloud.org/documents/23786932-fda-letter-on-covid-19-vaccine-labeling (same document, different format)

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