> According to the newspaper, the doses likely come from AstraZeneca's Halix plant in the Netherlands, which hasn't yet been approved for EU production.
As of two days ago AstraZeneca hadn't sought approval for the plant [0].
And I've heard insinuations that they are not in a hurry to apply, cause they can hide behind the lack of approval for their lack of European deliveries, and in the meantime export vaccines at a premium to the UK. Not sure if any of this is true, but it would be quite a thing. Hope they just get nationalized
So the EU hasn't allowed any of the doses manufactured at the Netherlands plant to be used but the plant was producing doses on schedule with the previously stated goals, and even possibly met the first quarter goals, and now AstraZeneca is somehow in trouble for this?
It seems like this should simply motivate the EU review of the Netherlands plant to speed up, so that all these doses can be used as soon as possible if they're safe and effective. What am I misunderstanding here?
AZ hasn't submitted the paperwork yet and doesn't seem to be in a rush doing that. EMA has said they can do the approval within 3 days or so after receiving the paperwork.
Another comment indicates that AstraZeneca didn't apply for approval for the Netherlands plant until very very recently. OK, so pointing blame at them seems fair then.
AZ is not applying for approval and the EU cannot (apparently) force them to apply for it. Since the EU has (so far) had unrestricted export of vaccines AZ does not have much of a hurry to change the status quo.
Discover as in finding out they where there. The plant that made them had not applied for, and so had not received, permission to supply the EU. Since they were officially not fit for use in the EU, it's perfectly plausible that AZ did not report their existence to the EC.
From the article and comments in this thread it seems that:
- The AstraZeneca didn't sought approval of the Halix plant, approval seems to be a fast process.
- They seem to be meant for export.
Which makes me wonder if maybe all of the Halix plant production is meant for export (speculation 1) and if maybe they intentionally didn't seek approval of the plant because of reasons like this making all vaccines produced there "not valid for consumption in EU" and (maybe, speculation 2) "not neccessary to be listed when reporting to the EU" and (maybe, speculation 3) "not affected by any export controls because they are not valid vaccines".
Be aware that I think speculation 1 is likely but 2 and 3 get increasingly less likely. It can be as simple as saving a buck by avoiding regulative control on a plant which isn't meant to produce for the countries doing the regulation anyway.
only one of the five vaccine-production plants listed in the EU contract with AstraZeneca was delivering vaccines to the EU.
The contract lists two factories in Britain, one in the Netherlands (Halix), one in Belgium. Another one in the United States is listed as a back-up supplier. Currently, only the plant in Belgium, run by Thermo Fisher Scientific, is producing shots for the EU.
The Commission has also started a procedure foreseen under the contract with AstraZeneca that could lead to legal action against the company.
The FT and Telegraph are reporting from sources in the EU and UK that these doses were due to be sent to European and developing countries under the COVAX programme.
The FT makes no such claim, they state that the lots were destined for AZ distribution site in Belgium and that the local company has no further knowledge.
The comment about COVAX is a general concern about EU export restrictions and not connected to the lots discovered.
The BBC is reporting that both UK and Italian governments say that the doses were destined for Belgium. I haven't got a direct link, it's in the BBC's rolling updates.
It mentions that the UK apparently haven't authorized this site either, that production started in October and first batches finished in December, and finally that AZ recently wanted to export "study materials" but then withdrew the applications when they got closer questions
I have saved up a lot of anger for headlines like this one.
I'll give all the incompetent politicians pass, all the knee-jerk lockdown regulations that were badly made, all errors in prioritizing and assigning vaccines, all the games between nations about who got to be first. All pales in insignificance to hoarding vaccine and waiting, instead of putting it into people's arm's ASAP.
They were apparently producing these in secret against regulations. They were waiting for the EU to approve them. I don’t think it’s quite all on AZ in this case. They were in defiance of regulations to even make those doses.
Edit: nevermind, seems they didn’t even ask for approval.
I think in years to come, the story of the AstraZeneca vaccine is going to make for some fascinating documentaries. The whole thing has been a series of weird problems from start to finish (starting with AZ being chosen as the partner in the first place, arguably).
According to "Le Canard Enchainé" [0] this is because:
- They agreed not to make profits on the vaccines for the first year or so (that was imposed by Oxford)[1]
- There's no penalty for not reaching the delivery targets in their contract with the EU.
So since they have no financial incentives in delivering more, they simply subcontracted the production, and are not making much effort in solving the various production issues.
[0] A famous, print only, French political news-paper, which is generally considered quite reliable.
A lot of their problems seem to come down to the fact that they aren't experienced in vaccines so have made multiple missteps along the way because of that on the procedural side of things.
Their choice as partner for the Oxford vaccine was purely political. Merck were originally the preferred choice (and they have a lot of vaccine experience) and a deal was almost done, but the UK vetoed it because all production would be in the US and they wouldn't offer the guarantees the UK had gotten from Oxford as part of their funding of the Vaccine development.
i think it’s due to the fact AZN isn’t a traditional vaccine producer.
what’s most striking to me is the complete silence (till recently) of the big 3 vaccine manufacturers: gsk, merck and sanofi. no vaccines from the biggest producers?
AstraZeneca vaccine document shows limit of no-profit pledge
Company has right under contract to declare pandemic over by July 2021
AstraZeneca, which has promised not to profit from its Covid-19 vaccine “during the pandemic”, has the right to declare an end to the pandemic as soon as July 2021, according to an agreement with a manufacturer.
AstraZeneca consistently makes more than $3B in net income every year, $5B last year.
EU paid 1.78€ per dose. Even if AstraZeneca loses money on every dose, let's say it costs them 20% more to produce, that's only some ~65M€ loss on the EU order. The hypothetical loss is a rounding error to their bottom line, while the damage already incurred to the brand image and goodwill is colossal.
The article in the NY times regarding what the NIH said yesterday seems very odd. Even Dr. Fauci was not happy with it as seems quite unusually for procedural errors to be made public in such a way.
Wouldn't AstraZeneca be still required to deliver the orders at the price that it was agreed?
IIRC, most of the EU, has already ordered enough vaccines for the whole population.
The fact that you've pointed out, still doesn't still well with me though. If most developed countries will already have been vaccinated, are they trying to take the profit from developing economies instead?
The 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.
Political issues are not new in Europe. Having lived in France, I thought the question on the vaccine was due to strict high quality standards in healthcare. But the problems with Oxford/AstraZeneca seems to be a political puzzle (May be I am wrong)
I thought it was wrong for the EU to take such a paranoid view of the way the UK was getting its vaccines. Seems they were on to something after all. At this point it wouldn't surprise me that the UK had secretly siphoned AZ's EU production since day 1. But who knows...
The contracts clearly state the UK is first in line. There's nothing shady or underhanded going on. AZ is just honoring it's most important contract first.
[+] [-] tpush|5 years ago|reply
As of two days ago AstraZeneca hadn't sought approval for the plant [0].
[0] https://www.reuters.com/article/us-health-coronavirus-eu-uk-...
[+] [-] tda|5 years ago|reply
[+] [-] bradfa|5 years ago|reply
It seems like this should simply motivate the EU review of the Netherlands plant to speed up, so that all these doses can be used as soon as possible if they're safe and effective. What am I misunderstanding here?
[+] [-] markus92|5 years ago|reply
[+] [-] bradfa|5 years ago|reply
[+] [-] the_duke|5 years ago|reply
Which makes the number found here really curios.
[+] [-] the_mitsuhiko|5 years ago|reply
[+] [-] airhead969|5 years ago|reply
https://www.cnn.com/2021/03/04/europe/italy-astrazeneca-dose...
[+] [-] SiempreViernes|5 years ago|reply
[+] [-] the-dude|5 years ago|reply
Who is responsible for the approval? AFAIK the Brits have no problems with the Halix plant.
[+] [-] rsynnott|5 years ago|reply
[+] [-] dathinab|5 years ago|reply
- The AstraZeneca didn't sought approval of the Halix plant, approval seems to be a fast process.
- They seem to be meant for export.
Which makes me wonder if maybe all of the Halix plant production is meant for export (speculation 1) and if maybe they intentionally didn't seek approval of the plant because of reasons like this making all vaccines produced there "not valid for consumption in EU" and (maybe, speculation 2) "not neccessary to be listed when reporting to the EU" and (maybe, speculation 3) "not affected by any export controls because they are not valid vaccines".
Be aware that I think speculation 1 is likely but 2 and 3 get increasingly less likely. It can be as simple as saving a buck by avoiding regulative control on a plant which isn't meant to produce for the countries doing the regulation anyway.
[+] [-] reddotX|5 years ago|reply
The contract lists two factories in Britain, one in the Netherlands (Halix), one in Belgium. Another one in the United States is listed as a back-up supplier. Currently, only the plant in Belgium, run by Thermo Fisher Scientific, is producing shots for the EU.
The Commission has also started a procedure foreseen under the contract with AstraZeneca that could lead to legal action against the company.
https://www.reuters.com/article/idUSKBN2BF141
[+] [-] krona|5 years ago|reply
[+] [-] SiempreViernes|5 years ago|reply
The comment about COVAX is a general concern about EU export restrictions and not connected to the lots discovered.
[+] [-] jadavies|5 years ago|reply
[+] [-] kmlx|5 years ago|reply
[+] [-] polytely|5 years ago|reply
https://www.nrc.nl/nieuws/2021/03/24/wie-krijgt-de-vaccins-u...
[+] [-] SiempreViernes|5 years ago|reply
It mentions that the UK apparently haven't authorized this site either, that production started in October and first batches finished in December, and finally that AZ recently wanted to export "study materials" but then withdrew the applications when they got closer questions
[+] [-] hengheng|5 years ago|reply
I'll give all the incompetent politicians pass, all the knee-jerk lockdown regulations that were badly made, all errors in prioritizing and assigning vaccines, all the games between nations about who got to be first. All pales in insignificance to hoarding vaccine and waiting, instead of putting it into people's arm's ASAP.
[+] [-] bitexploder|5 years ago|reply
Edit: nevermind, seems they didn’t even ask for approval.
[+] [-] rsynnott|5 years ago|reply
[+] [-] byroot|5 years ago|reply
[0] A famous, print only, French political news-paper, which is generally considered quite reliable.
[1] https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b...
[+] [-] zpeti|5 years ago|reply
But the politics of it, absolutely.
[+] [-] snowwolf|5 years ago|reply
Their choice as partner for the Oxford vaccine was purely political. Merck were originally the preferred choice (and they have a lot of vaccine experience) and a deal was almost done, but the UK vetoed it because all production would be in the US and they wouldn't offer the guarantees the UK had gotten from Oxford as part of their funding of the Vaccine development.
https://www.theguardian.com/society/2021/jan/29/we-had-to-go...
[+] [-] kmlx|5 years ago|reply
what’s most striking to me is the complete silence (till recently) of the big 3 vaccine manufacturers: gsk, merck and sanofi. no vaccines from the biggest producers?
an interesting article that i found about this strange situation: https://www.google.co.uk/amp/s/amp.ft.com/content/657b123a-7...
[+] [-] brnt|5 years ago|reply
[+] [-] throwaway4good|5 years ago|reply
AZ has the option of raising the price by this summer.
Now they wouldn't, would they, just stock pile the stuff until summer?
https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b...
AstraZeneca vaccine document shows limit of no-profit pledge
Company has right under contract to declare pandemic over by July 2021
AstraZeneca, which has promised not to profit from its Covid-19 vaccine “during the pandemic”, has the right to declare an end to the pandemic as soon as July 2021, according to an agreement with a manufacturer.
[+] [-] throwawayzRUU6f|5 years ago|reply
EU paid 1.78€ per dose. Even if AstraZeneca loses money on every dose, let's say it costs them 20% more to produce, that's only some ~65M€ loss on the EU order. The hypothetical loss is a rounding error to their bottom line, while the damage already incurred to the brand image and goodwill is colossal.
[+] [-] dathinab|5 years ago|reply
[+] [-] sschueller|5 years ago|reply
[+] [-] unknown|5 years ago|reply
[deleted]
[+] [-] ORioN63|5 years ago|reply
IIRC, most of the EU, has already ordered enough vaccines for the whole population.
The fact that you've pointed out, still doesn't still well with me though. If most developed countries will already have been vaccinated, are they trying to take the profit from developing economies instead?
[+] [-] klelatti|5 years ago|reply
- 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|5 years ago|reply
[+] [-] itoocode|5 years ago|reply
[+] [-] Denvercoder9|5 years ago|reply
The root cause of the problems seem to be that AstraZeneca has sold more doses than they are able to produce, and that causes the political problems.
[+] [-] 627467|5 years ago|reply
[+] [-] collaborative|5 years ago|reply
[+] [-] breakfastduck|5 years ago|reply
The contracts clearly state the UK is first in line. There's nothing shady or underhanded going on. AZ is just honoring it's most important contract first.
[+] [-] speexmex|5 years ago|reply