3 ms·
So, does anyone know why Astra/Zeneca is not approved in the U.S.? Did they not try, or it's still ongoing, or did they have problems?
by rossdavidh 6y ago
So, does anyone know why Astra/Zeneca is not approved in the U.S.? Did they not try, or it's still ongoing, or did they have problems?
- sampo 6y agoMy understanding is, FDA requires data from trials run on US population. Trials from other countries are not sufficient alone. AstraZeneca is currently running a trial in the US.
- zain 6y agoThey haven’t submitted to the FDA for emergency use authorization yet because their trials aren’t done yet. Their trials started well after Pfizer/Moderna and are longer than J&J. They’re expected to apply in the next 3-4wks.
- pkaye 6y agoThe trial were delayed. I read just today that the results are being reviewed to see if sufficient for submittal to the FDA.