Is this the responsibility of AZ or the EU ,and why hasn’t the paperwork been submitted
Don’t believe CNN. The contracts signed by the UK with AZ(UK) on the back of the Licence Agreement signed between Oxford and AZ(UK) are materially different to that signed between AZ(EU/AB) and the EU.
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Yes, I’m curious about this too. The suggestions I’ve seen is that the factory hasn’t received EMA approval yet (its due this week apparently) because it was waiting on AZ to submit application for approval. If AZ intentionally delayed this then that is an issue as it would breach their BRE obligations (AZ is only obliged to deliver vaccines once it has approval). Will be interesting to know the truth behind this aspect.
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I think if it is an intentional delay then it shines a very bad light on AZ,could potentially suggest a UK involvement and explains some,but not all,of the EU’s behaviour.All speculation as only those closest to the situation know as of now.
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I’d be very surprised if it was intentional as what would be the point? Obviously, can’t rule anything out - but you’re right, it’s just speculation at this stage.
From what has been reported so far, the onus is on the company to submit. I do find it peculiar that the EU haven’t been publicly pressuring AZ to submit for approval though.
I imagine legally things might get murky if AZ sought EU approval for that plant but continued to fulfill its commitment to the UK only. So for them, it makes sense to keep the EU out of it to make things less difficult for them.
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Does AZ not need the plant to be approved anyway in order for it to export the vaccines? Isn’t this why there is this stockpile? It’s awaiting approval so it can be exported. Isn’t that why the UK hasn’t had any AZ vaccines from sites in the EU since the EU imposed the export authorisation process in late January?
Here:
https://twitter.com/tconnellyRTE/status/1374695000697622532
It is common to disagree about interpretation, but when that occurs you then don’t go public with numbers in direct antagonism to the regulatory board you are negotiating with.
People are still out there supporting AZ from the perspective of trying to uphold faith in the effectiveness of the vaccine, but there is almost no public support for their conduct in this specific situation. Almost universally from people familiar with the process the blame is being placed on AZ’s shoulders, and judging it as not just one of those things that happen, but a pretty inexplicable unforced error.
See Eric Topol as a fairly heavyweight example
https://www.awesomescreenshot.com/image/6783402?key=b11638a732d1647a24503cdd978d0a54
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It’s extremely frustrating. AZ are having enough problems from being unfairly maligned, they don’t need to give their detractors any further ammunition!
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Here are the numbers for The Netherlands, 
they seem to kickstart the vaccinations it’s the highest day total since 12-03-2021 although they start to vaccinate with AstraZeneca only from today on.
Vaccinations 23-03-2021: 44.040.
‘Only’ 331.767 vaccinations in 5 days (roughly 66.350 daily) to reach the ‘promise’ 400.000 for this week. 
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You know, somebody should do a breakdown of the number of times that false allegations have been directed towards AstraZeneca in the last few months. It all feels very deliberate.
I’ve just done a rough chronology from memory. Will add sources and precise dates when I have more time:
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AZ have advised that they will not deliver to the EU “promised” amount of vaccine doses in Q1.
False. Amount of doses and schedule were both estimates in the EU APA. No firm commitments or “promises”. -
AZ are required to supply EU from UK sites.
False. AZ is under an obligation to use BRE to supply Initial Europe Doses from EU sites. -
AZ is quasi-ineffective in over 65s and possibly over 60s too.
False. AZ has over 80% efficacy in over 65s. -
AZ only 8% effective for over 65s, Handelsblatt from German government source
False. -
Due to speed of MHRA approval, AZ vaccine is unsafe.
False. -
AZ causes bloodclots.
False. No evidence that AZ causes bloodclots. In fact, there is a reduced prevalance of bloodclots among those who have taken AZ than in the general population. Bloodclot reactions following AZ presented in equivalent numbers among those who had taken Pfizer and Moderna but AZ the only one suspended. -
Italian police raid AZ factory and discover AZ hiding 29 million doses, destined for export to the UK.
False. AZ in process of filling and bottling 29 million doses for distribution to the EU (16 million doses) and COVAX (13 million doses) as soon as approval given.
Other false claims include that the UK has an export ban (it doesn’t) or that the EU is exporting vaccines (it isn’t) or that the EU hasn’t blocked a single export (it has).
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Absolutely the primary measure is it’s ability to stop hospitalisation and death. But surely the secondary consideration is a vaccine’s ability to limit transmissibility, which in turn limits the likelihood of viral escape mutations that could reduce the effectiveness of present-day vaccines?
In terms of measuring it’s primary purpose, each of the approved vaccines are as effective as eachother. In terms of measuring their secondary purpose, which is their ability to limit transmission, especially transmission of mutations, on the evidence so far some are better at this than others.
As for when a vaccine trial takes place, I think the important thing to measure is the percentage of infection in the placebo group for each trial, as that gives a better indication of the prevalence of the virus within the trial than looking at country graphs, which don’t account for regional variations or a million other factors.
There were 162 cases of COVID infection observed in the Pfizer trial of 21,728 placebo participants. Therefore 0.75% of the placebo group were infected.
There were 195 instances of COVID infection in the placebo group of 19,691 participants in the J&J trial. Therefore 0.99% of the placebo group suffered infection.
They don’t appear to be massive differences on the face of it. The prevalence of the virus at the time of the trials appear to be relatively similar. At least I’m not seeing the differences in infection that could show the results of a trial? The affect of variants i’m sure would be a much bigger factor.
That Michigan mayor was a moron though, I think we all agree. A moron in possession of data he didn’t understand.
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It’s the responsibility of AZ that is more than clear!
To submit request for approval, yes. But has there been any avoidable delay on behalf of AZ in submitting this request? Has the EMA been sitting on the request longer than usual given it has been submitted?
Also, it’s probably relevant to point out that this plant (Halix) isn’t actually an AZ production facility but a subcontractor. Maybe the delay is with them?
I agree, AstraZeneca are in the wrong. They should not have released the interim result.
At the same time, once that mistake was made DSMB had a decision to make what a proportionate response is, and what will be the consequences.
A message of careful communication is undermined by someone obviously close to DSMB/NIAID leaking emails/memos to the Washington Post. I would argue equally or more unprofessional. Given sensationalist headlines it creates.
The statement could have simply read, efficacy is important and we look forward to AstraZenica releasing the final rather than the interim result later in the week. Whilst privately make their displeasure known.
That video above articulated (better than me) the limitations of efficacy calculations. We know the value is simply an estimate, not a true measure. One where single digit numbers of people alter the result by a few %. Where trial data, can differ from reality by 10 or 20%.
So the question becomes is it proportionate that they were seemingly happy with 75% (as reported in Washington post), to blow this up for AZ reporting the interim 79% ?
Poor scientific practice no doubt. Should get wrapped across the knuckles. But my perspective should not air dirty laundry in public. Over something meaningless for the public rather than scientific community (a level of accuracy implied, that does not match real world).
As Adrian Hill (Oxford Scientist who developed vaccine) his leaked email says. Its “extraordinary behaviour”, “Talk about efforts to maintain confidence in vaccines, what is going on ?!”
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I will try to respond later, Kopstar. Right now I am just in quickly.
Anyway, Angela Merkel is checking out what is available from Papa Bear due to the disastrous shortage:
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It’s difficult to know if Adrian is referring to NIAID or Astrazeneca. 
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