It looks like you're using an Ad Blocker.
Please white-list or disable AboveTopSecret.com in your ad-blocking tool.
Thank you.
Some features of ATS will be disabled while you continue to use an ad-blocker.
Source (FDA.gov) - Emergency Use Authorization for Vaccines Explained
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.
Source (FDA.gov) - Coronavirus (COVID-19) | Drugs
What is the difference between FDA approved drugs and drugs authorized under an emergency use authorization (EUA)?
...SNIP for brevity only...
"Emergency use authorization is NOT the same as FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA will consider whether a sponsor is working towards seeking FDA approval when evaluating the continued appropriateness of the EUA. "