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Italian authorities discover 29M Oxford/AstraZeneca doses: La Stampa

62 points by reddotX 6y ago

rsynnott 6y ago
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).
- zpeti 6y ago
  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.
  - te_chris 6y ago
    It’s not authorised in the US and the federal regulators keep raising their eyebrows at the data.
    - kmlx 6y ago
      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?
      - dtf 6y ago
        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.
        kmlx 6y ago
        interesting thanks. how long would a randomised controlled trial take?
        dtf 6y ago
        The AstraZeneca US phase 3 trial took about 7 months. https://clinicaltrials.gov/ct2/show/NCT04516746 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.
      - levosmetalo 6y ago
        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.
        kmlx 6y ago
        > 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.
        levosmetalo 6y ago
        and those authorities approved it because it's good and effective, or because it's the only one available on the market?
      - tinus_hn 6y ago
        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.
  - rsynnott 6y ago
    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.
    - varispeed 6y ago
      Aren't the issues created by over-regulation and bureaucrats throwing their spanners everywhere to cover their own incompetence?
      - Denvercoder9 6y ago
        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.
        varispeed 6y ago
        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?
        Denvercoder9 6y ago
        Hanlon's razor. Never attribute to malice what can be explained by incompetence. There's absolutely no evidence at all supporting your allegations.
        varispeed 6y ago
        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.
  - micdr0p 6y ago
    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-astrazeneca-vaccine https://www.niaid.nih.gov/news-events/niaid-statement-astraz...
  - kmlx 6y ago
    just last week AZN told the UK gov to not expect large quantities due to manufacturing issues in their UK plants.
- brnt 6y ago
  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?
  - markus92 6y ago
    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.
    - krona 6y ago
      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.
      - markus92 6y ago
        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.
    - sampo 6y ago
      > 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.
      - yread 6y ago
        > 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!
- kmlx 6y ago
  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-78ba-4fba-b18e-23c07e313331 https://www.google.co.uk/amp/s/amp.ft.com/content/657b123a-7...
  - ImprovedSilence 6y ago
    I heard merck is partnered with J&J to help make their vaccine.
    - kmlx 6y ago
      yes, after the Biden admin made a push. otherwise i don't think they would have gotten involved imo.
  - dtf 6y ago
    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-hollywood-movie-how-uk-struck-deal-to-guarantee-vaccine-supply-12204044 https://news.sky.com/story/covid-19-rejected-contracts-and-a...
    - 6y ago
- byroot 6y ago
  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. [1] https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b686 https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b...
- snowwolf 6y ago
  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-it-alone-how-the-uk-got-ahead-in-the-covid-vaccine-race https://www.theguardian.com/society/2021/jan/29/we-had-to-go...
  - klelatti 6y ago
    If it was all in the US then none would have been exported to either UK or EU? Seems like a good call.
    - snowwolf 6y ago
      Definitely. The EU had the same opportunity with BioNTech which was funded by Germany. But they allowed a partnership with Pfizer and now the US gets most of that production.
airhead969 6y ago
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-doses-australia-intl/index.html https://www.cnn.com/2021/03/04/europe/italy-astrazeneca-dose...
- SiempreViernes 6y ago
  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.
  - airhead969 6y ago
    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.)
    - SiempreViernes 6y ago
      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...
tpush 6y ago
> 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]. [0] https://www.reuters.com/article/us-health-coronavirus-eu-uk-idUSKBN2BD0RZ https://www.reuters.com/article/us-health-coronavirus-eu-uk-...
- tda 6y ago
  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
  - klelatti 6y ago
    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?
    - SiempreViernes 6y ago
      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-exported-from-netherlands-after-eu-export-controls/ https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
      - 6y ago
the-dude 6y ago
> 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.
- rsynnott 6y ago
  AZ has to apply to the EMA to have it approved. It seems they haven't done this. The whole thing is pretty odd.
  - the-dude 6y ago
    If they are using the facility for the UK, it seems pretty straightforward and logical to not seek approval.
    - rsynnott 6y ago
      The plant is listed as a supplier in the contract with the EU.
bradfa 6y ago
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?
- markus92 6y ago
  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.
  - bradfa 6y ago
    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.
    - arkitaip 6y ago
      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.
      - nemo44x 6y ago
        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.
hengheng 6y ago
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.
- bitexploder 6y ago
  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.
  - varispeed 6y ago
    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?
    - bitexploder 6y ago
      I think it would only apply if you tried to give it to a human other than yourself.
      - brianwawok 6y ago
        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?
      - varispeed 6y ago
        So they were completely fine to manufacture them as long as they were not given to people and countries like UK would accept those.
throwaway4good 6y ago
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/c474f9e1-8807-4e57-9c79-6f4af145b686 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.
- deleted 6y ago
  [deleted]
- sschueller 6y ago
  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.
- ORioN63 6y ago
  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?
  - dathinab 6y ago
    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.
speexmex 6y ago
This vaccine saga is turning into a James Bond movie. I'm loving it :)
dathinab 6y ago
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.
- reddotX 6y ago
  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 https://www.reuters.com/article/idUSKBN2BF141
  - dathinab 6y ago
    The fact that they list the helix plant in the contract but don't seek regulatory approval but still produce vaccines is quite questionable.
collaborative 6y ago
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...
- breakfastduck 6y ago
  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.
  - collaborative 6y ago
    "There's nothing shady or underhanded going on." Good joke
    - breakfastduck 6y ago
      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
  - rsynnott 6y ago
    > 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.
    - breakfastduck 6y ago
      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.
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 ago
  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.
  - klelatti 6y ago
    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.
    - the_mitsuhiko 6y ago
      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.
      - klelatti 6y ago
        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.
itoocode 6y ago
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)
- Denvercoder9 6y ago
  > 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.
627467 6y ago
It seems that AZ vaccine is revealing to be as controversial and politicized as Sputnik V.
polytely 6y ago
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-uit-de-dutch-mystery-factory-a4036989 https://www.nrc.nl/nieuws/2021/03/24/wie-krijgt-de-vaccins-u...
- SiempreViernes 6y ago
  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
krona 6y ago
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.
- SiempreViernes 6y ago
  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.
- jadavies 6y ago
  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.
- kmlx 6y ago
  yes, this was confirmed by both the EU and AZN.

62 points by reddotX 6y ago

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).

zpeti 6y ago
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.
- te_chris 6y ago
  It’s not authorised in the US and the federal regulators keep raising their eyebrows at the data.
  - kmlx 6y ago
    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?
    - dtf 6y ago
      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.
      - kmlx 6y ago
        interesting thanks. how long would a randomised controlled trial take?
        dtf 6y ago
        The AstraZeneca US phase 3 trial took about 7 months. https://clinicaltrials.gov/ct2/show/NCT04516746 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.
    - levosmetalo 6y ago
      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.
      - kmlx 6y ago
        > 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.
        levosmetalo 6y ago
        and those authorities approved it because it's good and effective, or because it's the only one available on the market?
    - tinus_hn 6y ago
      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.
- rsynnott 6y ago
  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.
  - varispeed 6y ago
    Aren't the issues created by over-regulation and bureaucrats throwing their spanners everywhere to cover their own incompetence?
    - Denvercoder9 6y ago
      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.
      - varispeed 6y ago
        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?
        Denvercoder9 6y ago
        Hanlon's razor. Never attribute to malice what can be explained by incompetence. There's absolutely no evidence at all supporting your allegations.
        varispeed 6y ago
        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.
- micdr0p 6y ago
  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-astrazeneca-vaccine https://www.niaid.nih.gov/news-events/niaid-statement-astraz...
- kmlx 6y ago
  just last week AZN told the UK gov to not expect large quantities due to manufacturing issues in their UK plants.
brnt 6y ago
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?
- markus92 6y ago
  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.
  - krona 6y ago
    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.
    - markus92 6y ago
      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.
  - sampo 6y ago
    > 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.
    - yread 6y ago
      > 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!
kmlx 6y ago
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-78ba-4fba-b18e-23c07e313331 https://www.google.co.uk/amp/s/amp.ft.com/content/657b123a-7...
- ImprovedSilence 6y ago
  I heard merck is partnered with J&J to help make their vaccine.
  - kmlx 6y ago
    yes, after the Biden admin made a push. otherwise i don't think they would have gotten involved imo.
- dtf 6y ago
  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-hollywood-movie-how-uk-struck-deal-to-guarantee-vaccine-supply-12204044 https://news.sky.com/story/covid-19-rejected-contracts-and-a...
  - 6y ago
byroot 6y ago
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. [1] https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b686 https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b...
snowwolf 6y ago
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-it-alone-how-the-uk-got-ahead-in-the-covid-vaccine-race https://www.theguardian.com/society/2021/jan/29/we-had-to-go...
- klelatti 6y ago
  If it was all in the US then none would have been exported to either UK or EU? Seems like a good call.
  - snowwolf 6y ago
    Definitely. The EU had the same opportunity with BioNTech which was funded by Germany. But they allowed a partnership with Pfizer and now the US gets most of that production.

airhead969 6y ago

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-doses-australia-intl/index.html https://www.cnn.com/2021/03/04/europe/italy-astrazeneca-dose...

SiempreViernes 6y ago
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.
- airhead969 6y ago
  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.)
  - SiempreViernes 6y ago
    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...

tpush 6y ago

> 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]. [0] https://www.reuters.com/article/us-health-coronavirus-eu-uk-idUSKBN2BD0RZ https://www.reuters.com/article/us-health-coronavirus-eu-uk-...

tda 6y ago
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
- klelatti 6y ago
  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?
  - SiempreViernes 6y ago
    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-exported-from-netherlands-after-eu-export-controls/ https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
    - 6y ago

the-dude 6y ago

> 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.

rsynnott 6y ago
AZ has to apply to the EMA to have it approved. It seems they haven't done this. The whole thing is pretty odd.
- the-dude 6y ago
  If they are using the facility for the UK, it seems pretty straightforward and logical to not seek approval.
  - rsynnott 6y ago
    The plant is listed as a supplier in the contract with the EU.

bradfa 6y ago

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?

markus92 6y ago
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.
- bradfa 6y ago
  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.
  - arkitaip 6y ago
    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.
    - nemo44x 6y ago
      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.

hengheng 6y ago

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.

bitexploder 6y ago
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.
- varispeed 6y ago
  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?
  - bitexploder 6y ago
    I think it would only apply if you tried to give it to a human other than yourself.
    - brianwawok 6y ago
      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?
    - varispeed 6y ago
      So they were completely fine to manufacture them as long as they were not given to people and countries like UK would accept those.

throwaway4good 6y ago

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/c474f9e1-8807-4e57-9c79-6f4af145b686 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.

deleted 6y ago
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sschueller 6y ago
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.
ORioN63 6y ago
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?
- dathinab 6y ago
  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.

speexmex 6y ago

This vaccine saga is turning into a James Bond movie. I'm loving it :)

dathinab 6y ago

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.

reddotX 6y ago
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 https://www.reuters.com/article/idUSKBN2BF141
- dathinab 6y ago
  The fact that they list the helix plant in the contract but don't seek regulatory approval but still produce vaccines is quite questionable.

collaborative 6y ago

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...

breakfastduck 6y ago
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.
- collaborative 6y ago
  "There's nothing shady or underhanded going on." Good joke
  - breakfastduck 6y ago
    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
- rsynnott 6y ago
  > 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.
  - breakfastduck 6y ago
    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.

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 ago
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.
- klelatti 6y ago
  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.
  - the_mitsuhiko 6y ago
    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.
    - klelatti 6y ago
      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.

itoocode 6y ago

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)

Denvercoder9 6y ago
> 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.

627467 6y ago

It seems that AZ vaccine is revealing to be as controversial and politicized as Sputnik V.

polytely 6y ago

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-uit-de-dutch-mystery-factory-a4036989 https://www.nrc.nl/nieuws/2021/03/24/wie-krijgt-de-vaccins-u...

SiempreViernes 6y ago
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

krona 6y ago

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.

SiempreViernes 6y ago
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.
jadavies 6y ago
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.
kmlx 6y ago
yes, this was confirmed by both the EU and AZN.