Anonymous ID: fa7c58 April 29, 2021, 4:09 a.m. No.13539915   🗄️.is 🔗kun   >>9917 >>9945

U.S. FDA explicitly states that everyone has THE OPTION TO ACCEPT OR REFUSE THE [EMERGENCY USE AUTHORIZATION] VACCINE

 

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

 

Emergency Use Authorization for Vaccines Explained

 

What is an Emergency Use Authorization (EUA)?

 

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. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

 

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA. …

 

How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?

 

FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website. …