General Discussion
In reply to the discussion: Father of five dies after texting fiancee: 'I should have gotten the damn vaccine' [View all]BumRushDaShow
(128,897 posts)The average vaccine's approval process usually takes a least 2 - 3 years.
The problem here is that because of the awful severity of COVID-19 and it being a global pandemic, a vaccine was actually authorized for "emergency use" (EUA) with about 6 months worth of data (although the various companies have been working on and off on these since SARS-CoV-1 in 2003).
So the general public is getting a "crash course" on the whole vaccine approval process.
And the approvals are not just looking at clinical data from the trials but other parts of the agency are looking at the manufacturing and testing processes to make sure that the product is both safe and effective, and is produced using rigorous manufacturing controls.
And we recently saw the reason why manufacturing needs to be looked at because look what happened with Emergent BioSolutions in Baltimore, which was supposed to help produce Janssen (J&J) and AstraZeneca vaccine (as a contract manufacturer) for both domestic and export use -
- https://www.baltimoresun.com/coronavirus/bs-hs-emergent-vaccine-halted-20210419-jebhmgem4jcidmo3pxptk7c46y-story.html
- https://www.cnbc.com/2021/05/19/employees-at-plant-that-ruined-millions-of-jj-covid-vaccine-doses-failed-to-shower-change-clothes.html
I did literally hear last night that Emergent has finally been given the go-ahead to resume making those vaccines - https://www.cnn.com/2021/07/29/health/fda-johnson-johnson-covid-vaccine-production/index.html