Free Republic
Browse · Search
General/Chat
Topics · Post Article

To: freedumb2003

“The vaccine went through ALL the steps any and all vaccines go through.”
_________________________________________

You are mistaken.

“An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.

The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.”


28 posted on 03/25/2021 6:44:50 AM PDT by Cathi
[ Post Reply | Private Reply | To 8 | View Replies ]


To: Cathi; freedumb2003

Thanks for thoroughly explaining how these unproven agents have NOT passed the stringent testing, that typical vaccines do.

I’m surprised to see anyone claim this.

Even the most ardent promoters know they have not....thus, the EUA, as you have mentioned.


31 posted on 03/25/2021 6:50:24 AM PDT by Jane Long (America, Bless God....blessed be the Nation πŸ™πŸ»πŸ‡ΊπŸ‡Έ)
[ Post Reply | Private Reply | To 28 | View Replies ]

Free Republic
Browse · Search
General/Chat
Topics · Post Article


FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson