How is a vaccine that is only approved for emergency use being mass distributed to younger and younger people as if it is really a general use therapy?
Has the phrase "emergency use authorization" lost its meaning, or was it really the proverbial camel's nose under the tent, intended to get the vaccine into the mainstream by any means necessary, and then treating it as if it had full FDA approval even though it does not?
Wasn't the "emergency use authorization" intended to get the vaccine into the most susceptible and at-risk people who were most likely to contract the virus based on what we knew at the time last December? Haven't recent studies shown that the decline in new cases is now trending more rapidly downward?
Can we honestly now say that we've exited the "emergency" period that started in December when the vaccine was first being rolled out? If so, then shouldn't we rethink the mass distribution of a vaccine that was only authorized for emergency use, and maybe slow down the rush to inject our children with it if the emergency period is behind us?
-PJ
Emergency Use Authorization is one of two emergency access mechanisms to provide new medicines to the public under specific circumstances. It’s not new. The guidelines for it are not new. The process for issuing EUAs is not new. Dozens of new medicines receive an Emergency Use Authorization each and every year; many of them cancer treatments. This is just the first time most people are seeing this designation and few in the general public have any idea what it means at this point.
There are also four expedited pathways for new medicine development: Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. More information about each of them is here: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
A more complete overview of all the programs, including the emergency access mechanisms is here: https://www.fda.gov/media/101333/download
You’ll notice the date on it is April 2016, which is the last revision. This is a routinely used process and just one of many. People seem to think that “FDA approval” is the only way new medicines become available and that it takes a decade. None of that is correct and it never has been.
One distinction that follows from “approved” vs. “emergency authorization” is which federal program applies to those who have claims.
I don’t believe there is a precedent for an emergency authorized treatment that was meant to apply to approximately 100% of the population.