3 ms·
> “They have not even filed an application with us yet”, Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday. Seems like Re
by Exmoor 6y ago
> “They have not even filed an application with us yet”, Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday.
Seems like Reuters is really reaching with this headline. "AstraZeneca Vaccine unlikely to be approved for European use until February" would be more accurate.
I have yet to see a primary source, but I keep seeing mentions that Oxford/AZ have apparently tweaked the time between the first and second shots which have dramatically improved the effectiveness. That may mean they need a little more time to get the exact data EU regulators want. UK is supposedly approving tomorrow.
I still haven't heard a peep about if they're even going to ask for US approval before their US trial reaches completion.
- mchusma 6y agoI had heard that the FDA rejected the outside the US data, stating it would not be sufficient for approval. They are supposed to be in constant communication with the regulators, so nobody is submitted EUA until its basically a sure thing.