Vaccine Approval 101

Here’s a tutorial on the usual process for vaccine development, testing and approval, for folks tracking the new coronavirus (COVID-19).  In brief: it will take a while and very large clinical trials to get a coronavirus vaccine approved at FDA. But preapproval testing is likely to happen on the ground where the coronavirus is spreading, and there is a potential for expanded access (to the unapproved vaccine) in the meantime.

Continue reading “Vaccine Approval 101”

Emergency Use Authorizations

Here’s a quick tutorial on the “emergency use authorization” (EUA) process at FDA, for folks following the coronavirus.  This explains in a little more detail the information that Dr. Gottlieb posted in a Twitter thread earlier today. 

Continue reading “Emergency Use Authorizations”