Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

Sure, but if Canada had a pending decision on a vaccine and didn’t want to export inventory until then would anyone blame them?

And decisions to invest in R&D and production facilities has consequences. Canada is finally getting on the ball to build a vaccine factory that will be ready in 2024. Maybe.



The US has no pending decision on AZ; AZ hasn’t applied for any kind of approval in the US, and officials have indicated that they hope AZ doesn't.


“The company's early April timeline has passed, but a spokesman on Wednesday said the company is still "progressing submission to the FDA."

https://www.fiercepharma.com/pharma/astrazeneca-still-plans-...

Likely not much demand but a positive FDA decision can boost confidence in other markets.


From your own sourcd, emphasis added:

“but AstraZeneca is still planning to apply for emergency use authorization of its shot in the U.S.”

planning to = has not


That’s because you don’t apply until you have your whole data package. There is no “apply as step 1” it’s “you submit your application when it’s complete”.

https://www.fda.gov/media/97321/download#page13


My point is the US doesn’t have a “pending decision” on AstraZeneca, the US has the potential (uncertain for many reasons) that they might apply at some time in the future.

Of course, AZ also lost its production capacity even if it was going to be approved, since it was dependent on the troubled Emergent facility which has been taken over but J&J and dedicated exclusively tonthe J&J vaccine, and has not located new production facilities.


Pending in the sense they told the FDA they will be filing for approval and are just waiting on data.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: