Italian authorities discover 29M Oxford/AstraZeneca doses: La Stampa(politico.eu)
politico.eu
Italian authorities discover 29M Oxford/AstraZeneca doses: La Stampa
https://www.politico.eu/article/italian-authorities-discover-29m-oxford-astrazeneca-vaccine-doses-la-stampa/
142 comments
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
This makes no sense:
- How are they hiding if they are getting criticised anyway (including here).
- UK is getting AZ vaccines at very low price like everyone else.
More likely they haven't applied because Halix plant doesn't meet EMA standards. So either EMA standards are unreasonable (as others are happy) or AZ (or a contractor) have messed something up.
And nationalized by who - they are Anglo / Swedish - so 50% UK / 50% EU?
- How are they hiding if they are getting criticised anyway (including here).
- UK is getting AZ vaccines at very low price like everyone else.
More likely they haven't applied because Halix plant doesn't meet EMA standards. So either EMA standards are unreasonable (as others are happy) or AZ (or a contractor) have messed something up.
And nationalized by who - they are Anglo / Swedish - so 50% UK / 50% EU?
The fact that they have 30 Million finished doses stored means they think they could sell them, there is little reason to store product you can't use and even less reason to put vaccine substance you think is of poor quality trough the bottling and packaging process.
The Halix site could reportedly make 5-6 million doses per month in January, so someone is evidently content with not even trying to get approval for the plant.
https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
The Halix site could reportedly make 5-6 million doses per month in January, so someone is evidently content with not even trying to get approval for the plant.
https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
So we can choose between:
- A conspiracy on the part of AZ and many of it EU employees (in a part Swedish company with a French national CEO) to deny EU citizens vaccines. They're doing this by refusing to seek approval for Halix.
- There is another reason why they haven't sought approval from EMA. I'd suggest the most likely is that they believe that they wouldn't get approval. Given the issues we've seen so far with manufacturing and regulation during the pandemic this seems to me to be very likely.
In the meantime what are they supposed to do with the vaccines they have already produced (which presumably wouldn't get EMA approval as they were made in a plant that wasn't approved) and which other countries have approved and which will save lives when they are used?
I'm not saying either side is in the right - just that a conspiracy seems the least likely underlying cause.
- A conspiracy on the part of AZ and many of it EU employees (in a part Swedish company with a French national CEO) to deny EU citizens vaccines. They're doing this by refusing to seek approval for Halix.
- There is another reason why they haven't sought approval from EMA. I'd suggest the most likely is that they believe that they wouldn't get approval. Given the issues we've seen so far with manufacturing and regulation during the pandemic this seems to me to be very likely.
In the meantime what are they supposed to do with the vaccines they have already produced (which presumably wouldn't get EMA approval as they were made in a plant that wasn't approved) and which other countries have approved and which will save lives when they are used?
I'm not saying either side is in the right - just that a conspiracy seems the least likely underlying cause.
Uh, are you aware that AZ is massively short of its commitments to deliver doses due to manufacturing problems? They are something like 70 million doses short, so it is public knowledge that they have to choose which deliveries to honour first.
The particular plant started operating in October 2020, at which point things are far enough along that there is no practical reason for why an application can't be started.
The particular plant started operating in October 2020, at which point things are far enough along that there is no practical reason for why an application can't be started.
> due to manufacturing problems.
Precisely, which is why I think a manufacturing issue is the most likely reason why they haven't applied for EMA authorisation yet. EU regulators can be and have been very picky.
If you want to buy into the theory that they are choosing to favour the UK and other countries at the expense of the EU then fine. There may be on contractual reason why they feel they have to do that but some sort of conspiracy seems far fetched at this stage.
Precisely, which is why I think a manufacturing issue is the most likely reason why they haven't applied for EMA authorisation yet. EU regulators can be and have been very picky.
If you want to buy into the theory that they are choosing to favour the UK and other countries at the expense of the EU then fine. There may be on contractual reason why they feel they have to do that but some sort of conspiracy seems far fetched at this stage.
would make a bit of sense, but isn't it more fun to think of BigFarma as a bunch of conspiring, greedy MBA's with no morals that will do anything for a profit?
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?
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.
Reportedly that site could make up to 6 million doses per month at the start of March, so they've been chugging for a good while without applying if they aloe supplied those 29 Million doses.
https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
Being an outsider to the EU (I'm in the US) it seems like there's a *LOT* more drama around vaccine manufacturing and distribution in Europe than in many other places.
The EU's the only major manufacturer that allows (until very recently) unrestrained export, which is always going to cause more controversy. Most EU production is exported. AZ is particularly messy because it's dramatically underproducing relative to its own projections, and because there was a lot of messiness about the contracts.
We are talking about 27 countries with vastly different governments and cultures, of course there's bound to be drama when dealing with a pandemic as difficult as covid-19 for the first time. But I'll say it's been disappointing seeing how tribal some countries have become when push comes to shove.
Isn’t one of the main purposes and legitimizers of any government that it protects its citizens? I’m sort of shocked that the EU is allowing export outside the EU during the initial rollout.
It sort of looks from the outside that Brexit was done just in time as the UK government is now saving more UK lives than they would otherwise. If I were an EU member I would be extremely critical of the current regime and truly question how they are legit when the EU is far behind the rest of the developed world in this.
It’s not fair to EU citizens that pay into the pot of mostly unelected representation.
It sort of looks from the outside that Brexit was done just in time as the UK government is now saving more UK lives than they would otherwise. If I were an EU member I would be extremely critical of the current regime and truly question how they are legit when the EU is far behind the rest of the developed world in this.
It’s not fair to EU citizens that pay into the pot of mostly unelected representation.
> I’m sort of shocked that the EU is allowing export outside the EU during the initial rollout.
What can we say? Once upon a time there was a belief that the world could come together and solve it problems if there just was some good will among the countries of the world.
This spirit still survives in the EU leadership that have spent so much time working for that on the European scale, so they simply have too much faith in international collaboration.
What can we say? Once upon a time there was a belief that the world could come together and solve it problems if there just was some good will among the countries of the world.
This spirit still survives in the EU leadership that have spent so much time working for that on the European scale, so they simply have too much faith in international collaboration.
nemo44x(1)
> I’m sort of shocked that the EU is allowing export outside the EU during the initial rollout.
So, if everyone had brought in export bans, then it's likely that wouldn't have been the end of it; trade restrictions on precursors and equipment and those little glass bottles (these were seriously a problem for vaccine manufacture at one point) would have followed, and world production would have ground to a halt. No country/bloc except possibly China can make a vaccine in large quantities single-handed.
The EU's mistake was in being the only big producer not to ban or heavily restrict export; being the last one to do it would be very dangerous and more likely to cause escalation. That's still a concern for current proposed EU export restrictions.
So, if everyone had brought in export bans, then it's likely that wouldn't have been the end of it; trade restrictions on precursors and equipment and those little glass bottles (these were seriously a problem for vaccine manufacture at one point) would have followed, and world production would have ground to a halt. No country/bloc except possibly China can make a vaccine in large quantities single-handed.
The EU's mistake was in being the only big producer not to ban or heavily restrict export; being the last one to do it would be very dangerous and more likely to cause escalation. That's still a concern for current proposed EU export restrictions.
[deleted]
[deleted]
Of course, in the USA exporting vaccines to other countries is simply not allowed, and if they want to sell, they need to sell it to the US government. The same applies to UK.
The fact that EU is the only western entity that produces vaccines and where export is allowed makes it much more complicated.
The fact that EU is the only western entity that produces vaccines and where export is allowed makes it much more complicated.
Honestly it makes it look needlessly complicated and putting their own people last. If I were an EU citizen, I’d be hyper critical of the regime as it stands today. This is fair.
There's a lot of scepticism with regards to vaccines, which, in the current situation, the European Commission and national governments are keen not to encourage. There are also a couple of unfortunate incidents in recent memory which exacerbate the situation.
https://en.wikipedia.org/wiki/Pandemrix
https://en.wikipedia.org/wiki/Pandemrix
Err, the national governments and the European Commission are very much encouraging the skepticism especially in regards to AZ.
Saying it's not effective for older people, temporarily banning it, saying it's not for younger people etc. At this point a lot of average people are skeptical not because they are anti-vaxx but because of the mixed messages from the governments.
Saying it's not effective for older people, temporarily banning it, saying it's not for younger people etc. At this point a lot of average people are skeptical not because they are anti-vaxx but because of the mixed messages from the governments.
You really don't want to be on the wrong side of history for this.
Delay 2 weeks to double check some reaction numbers vs rush and possibly cause thousands of deaths?
I think it's good they were willing to put on brakes if not sure, and good they resumed when science told them it was fine.
Delay 2 weeks to double check some reaction numbers vs rush and possibly cause thousands of deaths?
I think it's good they were willing to put on brakes if not sure, and good they resumed when science told them it was fine.
I think it's good they were willing to put on brakes if not sure, and good they resumed when science told them it was fine.
Except that's not the order that things went. They put on the brakes after 'science' told them it was fine to continue, and then resumed based on no new (public) scientific information.
Even if their intentions are good, the timing and communication around the whole things looks and feels chaotic and arbitrary and does not make people feel confident that they have any idea what they are doing.
Except that's not the order that things went. They put on the brakes after 'science' told them it was fine to continue, and then resumed based on no new (public) scientific information.
Even if their intentions are good, the timing and communication around the whole things looks and feels chaotic and arbitrary and does not make people feel confident that they have any idea what they are doing.
'Science told them it was fine' before they pumped the breaks, too. You can excuse anything based on caution but both before and after the fact the expected value of the decision was that it will cost lives.
Temporary bans were decided by state members, not the EU.
> Saying it's not effective for older people
Nobody said that; they said that the trial showed no statistically useful evidence that it was effective for older people (which was true, at least for the original trial). Given limited supplies of AZ it arguably made more sense to use the more plentiful Pfizer vaccine for groups it was known to work on, and use the rarer AZ vaccine for groups it was known to work on.
This was informed by the limited supply; if AZ had been the main vaccine available decisions were different. As it is, restricting AZ to under 65s didn't meaningfully slow rollouts in countries that did it.
Nobody said that; they said that the trial showed no statistically useful evidence that it was effective for older people (which was true, at least for the original trial). Given limited supplies of AZ it arguably made more sense to use the more plentiful Pfizer vaccine for groups it was known to work on, and use the rarer AZ vaccine for groups it was known to work on.
This was informed by the limited supply; if AZ had been the main vaccine available decisions were different. As it is, restricting AZ to under 65s didn't meaningfully slow rollouts in countries that did it.
After Brexit, the COVID crisis was seen by the EU commission as well as the new EU president as a way to prove the value of the EU.
As a consequence, the EU imposed that the commission would lead the vaccine acquisition negociation. The plan was simple: prevent countries from talking to the labs, get a good deal on the vaccines because you represent a huge market, and then use that victory to justify the EU existence/need after the Brexit blow.
Of course that plan did not materialize, the EU "great deal" that was announced by an overly confident Ursula von der Leyen was just smoke and mirrors, and now that the reality is hitting, the EU tries to do everything in it's power - as an aferthought - to do some damage control. And it's not pretty.
As a consequence, the EU imposed that the commission would lead the vaccine acquisition negociation. The plan was simple: prevent countries from talking to the labs, get a good deal on the vaccines because you represent a huge market, and then use that victory to justify the EU existence/need after the Brexit blow.
Of course that plan did not materialize, the EU "great deal" that was announced by an overly confident Ursula von der Leyen was just smoke and mirrors, and now that the reality is hitting, the EU tries to do everything in it's power - as an aferthought - to do some damage control. And it's not pretty.
I think this has been a massive victory for Boris Johnson. Very much an “I told you so” moment the Conservative Party can relish.
I hope the EU gets it together and maybe other developed countries can help them after some time. It’s sad to see my friends there headed into another lockdown when everyone else is planning parties and trips for this summer and just getting back to life.
I hope the EU gets it together and maybe other developed countries can help them after some time. It’s sad to see my friends there headed into another lockdown when everyone else is planning parties and trips for this summer and just getting back to life.
Sorry to say but tbh... the EU is viewed as a scrap yard where you dump politicians you can't afford to have around anymore in the national parliaments.
And these guys shall now solve a problem for real despite having a track record of being unable to do so?
And these guys shall now solve a problem for real despite having a track record of being unable to do so?
There's a difference between the parliament, from which elected members come from European list and the executive body where commissioner places are really hard to get.
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.
If AZ until recently thought they were going to be shipping those doses to the UK, and the UK has approved that, then it's hard to fault AZ for not applying to have the plant approved in a jurisdiction that it wasn't intended to be used for anyway.
Well, their delivery contracts to the EU also mention this exact plant so they really had no reason to think they could ship all its production to the UK...
Fair enough
there could be some reasons behind this. no one knows why thou...
Given the quantity of doses stored, it seems likely AZ has been having them make doses that (likely) pass their own QA for some time so they should be in shape to receive approval for a comparable amount of time.
To me one likely explanation for this is that AZ was holding off on applying to the EU in the hope that they could make these doses "in secret" and sell them outside the EU.
Another, more mundane one, is that their back office is just a total shitshow with so much panic going on that somebody just didn't file it.
To me one likely explanation for this is that AZ was holding off on applying to the EU in the hope that they could make these doses "in secret" and sell them outside the EU.
Another, more mundane one, is that their back office is just a total shitshow with so much panic going on that somebody just didn't file it.
Does anyone have any insights as to why it seems like AZ has mismanaged everything from the start?
There's plenty of blame to go around.
The EU started negotiating later and signed a contract with fewer remedies than the UK (https://www.politico.eu/article/the-key-differences-between-...). It's not at all surprising that AZ is focusing their efforts on the UK.
The EU started negotiating later and signed a contract with fewer remedies than the UK (https://www.politico.eu/article/the-key-differences-between-...). It's not at all surprising that AZ is focusing their efforts on the UK.
Right, the contract with the EU alone explains why they fail to meet their commitments, have trouble with the manufacturing plant, screw up the dosing in the trials, and don't promptly provide proper paperwork to authorities during at basically all stages of the process.
Must have been some contract...
Must have been some contract...
the only guess going around is that they're not a traditional vaccine manufacturer. as such, they don't have the expertise for this kind of a roll out.
but this is still a guess at this point.
but this is still a guess at this point.
I was wondering that, but they seem to be a more mature company than Moderna, and have more experience with bringing out products in general.
Did Moderna get more support from other companies/the government?
Did Moderna get more support from other companies/the government?
Moderna got 955 million for investment of their vaccine back in May, and an additional 1.53 billion back in August for the purchase of 100 million doses which has also further been increased to 300 million doses now: https://www.cnbc.com/2020/08/14/the-us-has-already-invested-...
And I guess the unstated conclusion is that they wisely spent a chunk of that money on hiring people with a long history of FDA compliance, regulatory guidelines, international export regulations, and product management?
(I suppose my point is that I would have expected such teething problems from a young company like Moderna, but they seem to have done everything right.)
(I suppose my point is that I would have expected such teething problems from a young company like Moderna, but they seem to have done everything right.)
Yes, that money came from the US government program literally codenamed "Operation Warp Speed" which was set up as a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics: https://en.wikipedia.org/wiki/Operation_Warp_Speed
Besides conspiracy speculations, it could be as simple as that in their planing they want to export 100% of Halix plains production and as such have no reason to seek regulatory improvement of the plant.
but how can they export it since the EU requires export approval since January?
They can't but they probably try to argue that since it's not "not a valid vaccine" in the EU it's "not affected by export controls".
Through I think that isn't going anywhere outside of bureaucracy, it's still a valid export controlled vaccine just not produced in a valid way.
But then if the pandemic would have been mostly over by now they would probably have gotten away with it.
Through I think that isn't going anywhere outside of bureaucracy, it's still a valid export controlled vaccine just not produced in a valid way.
But then if the pandemic would have been mostly over by now they would probably have gotten away with it.
As mentioned by others, they haven't requested approval, and are currently 30 million doses short of their first quarter obligations.
Which makes the number found here really curios.
Which makes the number found here really curios.
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.
Did they really "discover" them or impound them for domestic use? There was another story about Italy disallowing export of AZ vaccines to .au.
https://www.cnn.com/2021/03/04/europe/italy-astrazeneca-dose...
https://www.cnn.com/2021/03/04/europe/italy-astrazeneca-dose...
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.
Interesting. So they couldn't use them yet in the EU. Then the export matter would possibly be separate? (There are millions of AZ vaccines in Ohio and Maryland waiting to become the 4th approved vaccine in the US, but are stuck in FDA EUA paperwork.)
Yes, but they couldn't use them yet in the EU by their own choice.
And given how much was stocked up, the plant itself has been making QA approved product for a while, so they were evidently not in a rush to get that approval either...
And given how much was stocked up, the plant itself has been making QA approved product for a while, so they were evidently not in a rush to get that approval either...
> the doses likely come from AstraZeneca's Halix plant in the Netherlands, which hasn't yet been approved for EU production.
Who is responsible for the approval? AFAIK the Brits have no problems with the Halix plant.
Who is responsible for the approval? AFAIK the Brits have no problems with the Halix plant.
AZ has to apply to the EMA to have it approved. It seems they haven't done this. The whole thing is pretty odd.
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.
- 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.
https://www.reuters.com/article/idUSKBN2BF141
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
The fact that they list the helix plant in the contract but don't seek regulatory approval but still produce vaccines is quite questionable.
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 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.
yes, this was confirmed by both the EU and AZN.
This article from Dutch newspaper NRC about the missing Halix vaccines and the tensions between the UK and EU is a fun read for more background info:
https://www.nrc.nl/nieuws/2021/03/24/wie-krijgt-de-vaccins-u...
https://www.nrc.nl/nieuws/2021/03/24/wie-krijgt-de-vaccins-u...
Very good article, even machine translated.
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
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.
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.
Edit: nevermind, seems they didn’t even ask for approval.
It doesn't sound like that, no. It seems those doses were legal for use in the UK, which had already approved that plant. It seems these were bound for exports, so not clear why the Italians have them.
Are vaccines a controlled substance? If I wanted to create a vaccine in my spare bedroom, would I have to seek bureaucrat to approve my bio shenanigans?
I think it would only apply if you tried to give it to a human other than yourself.
So they were completely fine to manufacture them as long as they were not given to people and countries like UK would accept those.
In most of the US until very recently you couldn't grow pot for yourself.
So mix some random chemicals and inject yourself = legal
Mix random chemicals that happen to be a controlled substance and inject yourself = illegal?
What happens if you accidentally rediscover a controlled substance?
So mix some random chemicals and inject yourself = legal
Mix random chemicals that happen to be a controlled substance and inject yourself = illegal?
What happens if you accidentally rediscover a controlled substance?
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:
[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...
- 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.
[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...
Seems to be working just fine in the UK, US, India, Hungary, so I don't think any of the issues are to do with Astrazeneca.
But the politics of it, absolutely.
But the politics of it, absolutely.
AZ has had severe production issues. AZ's working in the UK because they're getting most of the production, but they've delivered only a small fraction of what they said they would in the EU. They've also had _two_ botched trials now, leading to delays in approval (a couple of months for the EU, nearly six months for the US). And now this.
Aren't the issues created by over-regulation and bureaucrats throwing their spanners everywhere to cover their own incompetence?
Eh? No. Where did you get that? AZ's production shortfall isn't just an EU thing; it's general. The other manufacturers have no such issues; Pfizer-Biontec has actually been able to exceed promised production.
Pfizer seems to have a history of corruption - https://iclg.com/cdr/competition-and-business-crime/pfizer-p...
Keep in mind that AZ vaccine is not for profit so bureaucrats do not have many ways to make money from it and in their interest is pushing more expensive ones. This way you can explain the wave of fake news about blood clots and individual countries stopping vaccinations with AZ and scaring the public.
Keep in mind that AZ vaccine is not for profit so bureaucrats do not have many ways to make money from it and in their interest is pushing more expensive ones. This way you can explain the wave of fake news about blood clots and individual countries stopping vaccinations with AZ and scaring the public.
There's no evidence supporting that claim, and there have been no such problems with the Pfizer, Moderna and Johnson vaccins which had to comply with the same regulations.
These other vaccines are produced for profit so there is money to be made under the table for bureaucrats, whereas AZ does not have this potential. If bureaucrats can stamp out this vaccine they can make more money pushing the others.
Have you not seen the fake news about blood clots and other scare mongering to make people want to use other vaccines?
> there is money to be made under the table for bureaucrats
Corruption is by far not as bad here as in other places. See this [0] if you want to get an overview.
[0] https://en.wikipedia.org/wiki/Corruption_Perceptions_Index
Corruption is by far not as bad here as in other places. See this [0] if you want to get an overview.
[0] https://en.wikipedia.org/wiki/Corruption_Perceptions_Index
First world countries have just figured out that brown paper envelopes are gauche. Instead, you arrange a no-show job as a board member or consultant for a member of the politician's immediate family. All nice and squeaky clean!
This is just a report that collates the so called experts opinions and has no reflection in reality. I could create such report myself.
Hanlon's razor. Never attribute to malice what can be explained by incompetence.
There's absolutely no evidence at all supporting your allegations.
There's absolutely no evidence at all supporting your allegations.
Would that be a coincidence then that only vaccine made not for profit has such problems? Strange news coming? Allegations?
I think this may be both incompetence and corruption. We'll see - I hope this will be properly investigated including the bureaucrats involved in the decisions and their financial affairs.
just last week AZN told the UK gov to not expect large quantities due to manufacturing issues in their UK plants.
It’s not authorised in the US and the federal regulators keep raising their eyebrows at the data.
this is something i don’t get: if it works all around the world why aren’t the federal regulators simply fast tracking its approval?
are they not allowed to do that?
are they not allowed to do that?
Observational studies are a lower standard of evidence than randomised controlled trials. Countries with higher levels of vaccine skepticism (eg the US) seem to be erring on the side of doing things by the book. The UK, by comparison, enjoys a high degree of trust in its healthcare system and can afford to be a little more gung-ho.
interesting thanks.
how long would a randomised controlled trial take?
how long would a randomised controlled trial take?
The AstraZeneca US phase 3 trial took about 7 months.
https://clinicaltrials.gov/ct2/show/NCT04516746
In this case, US regulators took issue with the company's press release, rather than the results of the trial itself.
https://clinicaltrials.gov/ct2/show/NCT04516746
In this case, US regulators took issue with the company's press release, rather than the results of the trial itself.
Who says AZ works around the world? It's the vaccine of the last resort, people will get it only if they can't get anything else because it's still better than nothing, at least for now.
And "better than nothing" is just temporary because AZ is very to completely ineffective against all virus mutations that are currently spreading.
If Russian and Chinese Sputnik and Sinovac vaccines were approved in the EU, we could save so many lives, but politics will rather try to force AZ than accept that they failed.
And "better than nothing" is just temporary because AZ is very to completely ineffective against all virus mutations that are currently spreading.
If Russian and Chinese Sputnik and Sinovac vaccines were approved in the EU, we could save so many lives, but politics will rather try to force AZ than accept that they failed.
> Who says AZ works around the world?
all the authorities that have approved it? all the people that got it? we're talking tens of millions of people and authorities across the planet.
all the authorities that have approved it? all the people that got it? we're talking tens of millions of people and authorities across the planet.
and those authorities approved it because it's good and effective, or because it's the only one available on the market?
Because normally they can get away with a drawn out process that takes years, and if in one country some medication is curing cancer and in another country is not approved, nobody bats an eyelid.
It’s a big bunch of fiefdoms that all want to do their own checks and it is a political minefield. Witness the ridiculous situation with the vaccination shutdown last week. Has nothing to do with science, everything with public image and politics.
And it’s setting themselves up to fail as well because in this situation if a manufacturer has contracts with countries A and B and A pays more, they’ll just focus on approval for country A and delay approval for country B, so it’s perfectly defensible to only deliver to country A and not the country who isn’t going to use it anyway.
Unfortunately this is all smoke and mirrors that goes way over the head of the general public so there’s no backlash for failing.
It’s a big bunch of fiefdoms that all want to do their own checks and it is a political minefield. Witness the ridiculous situation with the vaccination shutdown last week. Has nothing to do with science, everything with public image and politics.
And it’s setting themselves up to fail as well because in this situation if a manufacturer has contracts with countries A and B and A pays more, they’ll just focus on approval for country A and delay approval for country B, so it’s perfectly defensible to only deliver to country A and not the country who isn’t going to use it anyway.
Unfortunately this is all smoke and mirrors that goes way over the head of the general public so there’s no backlash for failing.
The AZ shot hasn't been approved in the US yet. They also released a study there where they're suspected of cherry-picking data to make it look good
https://www.niaid.nih.gov/news-events/niaid-statement-astraz...
https://www.niaid.nih.gov/news-events/niaid-statement-astraz...
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.
https://www.theguardian.com/society/2021/jan/29/we-had-to-go...
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...
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?
an interesting article that i found about this strange situation: https://www.google.co.uk/amp/s/amp.ft.com/content/657b123a-7...
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...
Merck was the Oxford team's first choice of manufacturer. But the UK health minister overruled and told them they needed to use a British manufacturer. [1]
"[T]he Oxford-AstraZeneca vaccine was very nearly the Oxford-Merck vaccine - and under the terms of the agreement with the American pharmaceutical giant, there were no guarantees of supply.
The episode played out against the backdrop of the first phase of the pandemic. During March and April 2020, the University of Oxford negotiated a deal which would allow Merck to manufacture and distribute the vaccine it was in the process of developing.
The arrangement made sense. Unlike British-Swedish AstraZeneca, Merck had experience in making vaccines. Its senior executives had links to Oxford scientist and government adviser Sir John Bell.
Yet when the contract reached Matt Hancock's desk, the former adviser said, the health secretary refused to approve it, because it didn't include provisions specifically committing to supply the UK first."
[1] https://news.sky.com/story/covid-19-rejected-contracts-and-a...
"[T]he Oxford-AstraZeneca vaccine was very nearly the Oxford-Merck vaccine - and under the terms of the agreement with the American pharmaceutical giant, there were no guarantees of supply.
The episode played out against the backdrop of the first phase of the pandemic. During March and April 2020, the University of Oxford negotiated a deal which would allow Merck to manufacture and distribute the vaccine it was in the process of developing.
The arrangement made sense. Unlike British-Swedish AstraZeneca, Merck had experience in making vaccines. Its senior executives had links to Oxford scientist and government adviser Sir John Bell.
Yet when the contract reached Matt Hancock's desk, the former adviser said, the health secretary refused to approve it, because it didn't include provisions specifically committing to supply the UK first."
[1] https://news.sky.com/story/covid-19-rejected-contracts-and-a...
then why not use gsk?
Not sure ... but didn't GSK partner with Sanofi on a vaccine that didn't work out? Sorry, I can't read your FT link :)
they partenerd with Sanofi, but that vaccine failed. so they moved to providing an "“adjuvant” — an ingredient that can be added to vaccines to boost immune response — to several vaccine makers"
I heard merck is partnered with J&J to help make their vaccine.
yes, after the Biden admin made a push. otherwise i don't think they would have gotten involved imo.
I've not been following AZ more closely than knowing why vaccinations in my country are delayed. What are the weird problems and events you speak of?
Overselling their production capacity by a lot, for one. The major protocol violations in their trials and the weird way they are handling it, are another.
There was no production capacity 12 months ago. EU suppliers failed to upgrade and improve yields sufficiently in time. The UK/US started expanding right at the start of the pandemic, so effectively had a 6-8 month head start.
Easy to say but not necessarily true. Let's look at the Halix factory, which is the main point of contention in the EU/UK dispute. The Dutch government (thus, EU) already offered them a major contract in March/April '20, for precisely this purpose. They already had started expanding in Feb '20 as part of their production for the AZ trial, so they declined.
> Overselling their production capacity by a lot, for one.
They grow live virus in live cell cultures. Scaling bioreactors from 50 liter test reactors to 1000 or 2000 liter production size reactors can be tricky. Even when everything goes well, bioreactors can have 3-fold differences in yield.
I would assume either AZ quoted the ideal production capacity. Or maybe AZ quoted a range, and EU politicians took the maximum of the range and believed that would be achievable.
They grow live virus in live cell cultures. Scaling bioreactors from 50 liter test reactors to 1000 or 2000 liter production size reactors can be tricky. Even when everything goes well, bioreactors can have 3-fold differences in yield.
I would assume either AZ quoted the ideal production capacity. Or maybe AZ quoted a range, and EU politicians took the maximum of the range and believed that would be achievable.
> Scaling bioreactors from 50 liter test reactors to 1000 or 2000 liter production size reactors can be tricky
Yes, especially if you've never done vaccine production before!
Yes, especially if you've never done vaccine production before!
There is something weird going on with the AZ vaccine. One of things is that it is being sold at cost price at the moment.
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.
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.
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.
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.
I highly doubt that "right under contract to declare pandemic over by July 2021" is legally valid.
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.
[deleted]
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?
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?
It's likely that even if the pandemic is over vaccination still will need to be done for years to come (to prevent a new pan-/epidemic).
It's also likely that people on all sides of the contract thought that it will be more or less over at that point in time and the clause exists solely to prevent governments from just never declaring the pandemic from being over.
I also doubt that a clause like that is actually legal, tbh.
But hey maybe I'm just to optimistic.
It's also likely that people on all sides of the contract thought that it will be more or less over at that point in time and the clause exists solely to prevent governments from just never declaring the pandemic from being over.
I also doubt that a clause like that is actually legal, tbh.
But hey maybe I'm just to optimistic.
> Wouldn't AstraZeneca be still required to deliver the orders at the price that it was agreed?
Well, yes, but presumably if they take long enough then EU vaccination will be done and the contract will just be cancelled. The EU has ordered enough to dose something like 800 million people, so if manufacturers are amenable at least some contracts _will_ be terminated early down the line.
Well, yes, but presumably if they take long enough then EU vaccination will be done and the contract will just be cancelled. The EU has ordered enough to dose something like 800 million people, so if manufacturers are amenable at least some contracts _will_ be terminated early down the line.
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.
- 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 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.
Which 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.
And experience to date is that EMA has been more demanding than UK regulator.
I'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.
Except 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.
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.
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)
> But the problems with Oxford/AstraZeneca seems to be a political puzzle
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.
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.
It seems that AZ vaccine is revealing to be as controversial and politicized as Sputnik V.
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...
This is a load of nonsense.
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.
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.
> 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.
The UK's contract does, the EU's contract does not. In general, "I've decided another contract is more important, so I get to break yours without penalty" isn't a particularly credible defense if you're sued for breach of contract.
The UK's contract does, the EU's contract does not. In general, "I've decided another contract is more important, so I get to break yours without penalty" isn't a particularly credible defense if you're sued for breach of contract.
That isn't the defense though, they're making a pragmatic decision based on which contract is going to cause them the most harm if not fulfilled, which is the UKs.
"There's nothing shady or underhanded going on."
Good joke
Good joke
The contract says UK gets first dibs and AZ can be punished if they fail to supply the UK to the exact detail of the contract.
The EU contract says AZ will try their hardest.
Thats the reality. The EU wrote a shocking contract and are paying the price.
The EU propaganda machine is in full force rn
The EU contract says AZ will try their hardest.
Thats the reality. The EU wrote a shocking contract and are paying the price.
The EU propaganda machine is in full force rn
This vaccine saga is turning into a James Bond movie. I'm loving it :)
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-...