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FDA fast track designation has been around long before Covid-19 and any vaccine would have received that designation regardless of operation warp speed. It is
by cowsandmilk 5y ago
FDA fast track designation has been around long before Covid-19 and any vaccine would have received that designation regardless of operation warp speed.
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-accelerated-approval-priority-review/fast-track https://www.fda.gov/patients/fast-track-breakthrough-therapy...
- wolverine876 5y agoYes, more simply: The FDA isn't staffed by idiots. They were very aware of the situation and need.
- refurb 5y agoThe 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.
- wolverine876 5y agoWhy would the FDA need OWS to help them? How do you know OWS helped, and didn't hinder or wasn't completely irrelevant?
- wbl 5y agoUh, 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?