Re:Operation Warp Speed: A new model for industrial policy
by wolverine876 on Sunday January 30, 2022 @11:56PM
(#30144642)
Yes, more simply: The FDA isn't staffed by idiots. They were very aware of the situation and need.
Re:Operation Warp Speed: A new model for industrial policy
by refurb on Monday January 31, 2022 @12:36AM
(#30144926)
The vaccines were NOT approved by Fast Track or Breakthrough Therapy pathways.
The vaccines were approved through Emergency Use Authorization. Since no Covid vaccine had ever been produced before, the manufacturers and FDA had to come to an agreement on trial design, data needs and minimum thresholds.
That’s what OWS helped facilitate.
Re:Operation Warp Speed: A new model for industrial policy
by wolverine876 on Monday January 31, 2022 @02:20PM
(#30152791)
Why would the FDA need OWS to help them? How do you know OWS helped, and didn't hinder or wasn't completely irrelevant?
Re:Operation Warp Speed: A new model for industrial policy
by wbl on Monday January 31, 2022 @06:18AM
(#30146821)
Uh, is this the same FDA that can't get the CDC committee to meet on the same day? That delayed COVID trials by waiting for more followup unnecessarily? That has taken just as long to approve each vaccine rather than going faster as they get more practice?
It is so unrelated to Covid that FDA’s description of the fast track program hasn’t even been updated since 2018. https://www.fda.gov/patients/fast-track-breakthrough-therapy...