At the 161st FDA VRPBAC meeting on October 22, 2020 Dr Doran Fink expained why the regulatory pathway for the COVID-19 vaccines should follow the “regulatory standard” of EUA and not EAU.
The differences between expanded access use and Emergency Use Authorization are that expanded access use is done — or is carried out under FDA’s investigational new drug regulations. So among many other things, those regulations require use of an institutional review board and also obtaining informed consent from recipients of the investigational vaccine according to regulations for clinical investigations — research use of investigational vaccines. And so operationally speaking, an expanded access protocol would add some complexity, and that is why Emergency Use Authorization is being considered primarily as the mechanism for addressing the public health emergency that has been declared. Dr Fink, [from pg 203]
Dr Fink went on to work for Moderna!
“The FDA officials clearly explained here that the reason they went with EUA is specifically NOT to follow any investigational drug rules or cGxP, and NOT to provide informed consent” completely legal while under a declared Public Health Emergency (PHE)! [1]
So how did the mRNA products that were not subject to investigational drug standards (IND) (becasue the followed the EUA regulatory pathway) be able to obtain FDA approval for Biologics License Application (BLA), namely Pfizer on Aug. 23, 2021 and Moderna on Jan. 31, 2022?