undefined | Better HN

0 pointsceejayoz4y ago0 comments

Vaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.

0 comments

vlovich1234y ago

You've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved).

Said another way, what was the extra steps that needed to happen between EUA & full approval?

j / k navigate · click thread line to collapse

0 pointsceejayoz4y ago0 comments

0 comments

vlovich1234y ago

Said another way, what was the extra steps that needed to happen between EUA & full approval?

j / k navigate · click thread line to collapse