3 ms·
Without inside knowledge the best sense I can make of this is: - EMA has tougher approvals process than others (guessing but seems plausible). - Halix plant m
by klelatti 6y ago
Without inside knowledge the best sense I can make of this is:
- EMA has tougher approvals process than others (guessing but seems plausible).
- Halix plant meets others (UK) standards but not EMA standards yet.
- So AZ hasn't yet applied for approval with EMA yet.
- So Halix sourced vaccines can't be used in EU but can be elsewhere.
Cue outrage when AZ try to export these vaccines.
Obviously doesn't reflect well on someone but without detailed knowledge of standards / approvals process hard to say who.
- the_mitsuhiko 6y agoThe EMA already issued a statement that they can process the approval of the plant within days. AZ has not applied for approval yet and does not seem to be in a hurry to do so.
- klelatti 6y agoWhich doesn't contradict my speculation at all. If AZ think it won't get approval yet then they won't apply - to do so and fail would be another PR disaster. And experience to date is that EMA has been more demanding than UK regulator.
- the_mitsuhiko 6y agoI'm not saying it contracts your speculation necessarily. All I'm saying is that right now AZ is in a comfortable situation where they don't get any negative consequences of not applying for approval.
- klelatti 6y agoExcept that AZ is getting continual pressure from the EU to ship more vaccines to them - not comfortable at all. I'm certain if they could they would. The missing info is why the Halix plant isn't approved for EU but OK for elsewhere. Because the EMA rules are unreasonably onerous or because AZ has messed up.