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EU sues AstraZeneca over breach of Covid-19 vaccine supply contract
- cmrdporcupine 6y agoHad this vaccine over the weekend (in Canada) and given the supply concerns and all the drama around it I really wonder if I'll be able to get my second dose of it (scheduled for August at this point). I kind of wonder if my second dose will end up being Pfizer. Aside: While I am glad I took it, the side effects were brutal for my wife and I; fever, chills, nausea, agitation. Lasted about 36 hours. Not everyone gets this, but most of my friends who took it last week did, it's just anecdotal but it seems higher than the 1 in 10 statistic they're throwing around. I'm hoping that this strong immune system response correlates with future resistance to COVID.
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- lampe3 6y agoI got Moderna last week. And then I directly got the appointment for my second dose. As far as I know usually this is how it works here in Germany. Also In some EU countries they stopped AZ completely. I think there will be enough AZ left ... sadly.
- jfk13 6y agoPurely anecdotal, obviously, but I had my first dose of AZ about a month ago. Didn't notice any particular side effects. (I hope this doesn't mean it was less effective!) Remains to be seen how my system will deal with the second dose (scheduled for early June)....
- 908B64B197 6y ago> I really wonder if I'll be able to get my second dose of it (scheduled for August at this point) That's a long time to get the second dose. What explains such a long delay? The CDC recommends 4 weeks between doses [0]. [0] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/second-shot.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/second-sh...
- cmrdporcupine 6y agoThat's the gap in Canada because of supply constraints.
- shawabawa3 6y agoThat's for Pfizer/moderna vaccines. Astra zenica recommend 3 months between 1st and 2nd dose
- 908B64B197 6y agoThat makes sense.
- smnrchrds 6y agoCanada allows up to a 4 month gap between first and second doses, so they can give as many people their first dose as possible. In theory, it will allow Canada to achieve herd immunity earlier than it would otherwise. In practice, I guess we have to wait and see. https://www.theglobeandmail.com/opinion/editorials/article-how-a-four-month-gap-between-shots-could-end-canadas-pandemic-two/ https://www.theglobeandmail.com/opinion/editorials/article-h...
- 908B64B197 6y agoEven for the Pfizer and Moderna?
- cmrdporcupine 6y agoYes.
- youngtaff 6y agoThis study of 370,000+ participants suggests both AZ and Pfizer seem to produce good protection after a single dose https://www.ox.ac.uk/news/2021-04-23-significant-reductions-covid-19-infections-found-after-single-dose-oxford https://www.ox.ac.uk/news/2021-04-23-significant-reductions-...
- argvargc 6y agoIt seems for younger persons, the severity of adverse reactions to the vaccines may be worse than the would-be experience of naturally fighting off the virus itself.
- cmrdporcupine 6y agoJudging from the people I know who've had COVID, it's different symptoms and not at all as severe. Also I'm not that young (mid 40s) The adverse reaction to the vaccine was 24-36 hours of my life and now I'm fine. My friend who had COVID spent two weeks miserable up and down like a see-saw and then had long term foggy brain issues. Her husband had to go to the hospital to get oxygen.
- argvargc 6y agoSorry to hear about your friend - I don't mean to minimise the effects of serious cases. I'm referring to the proportion of cases which are asymptomatic or mild. In some seroprevalence studies asymptomatic reach up to 80%, though it can also be very low. Certainly some younger people seem to have a very bad time with COVID, but that's definitely not universal, suggesting controllable-factors may play a role in their difficulty fighting it off versus their peers, who seem at times to be capable of doing so without issue (rather than this being interpreted as intrinsic to the virus itself, a somewhat greater leap). To take one example - Vitamin D deficiency. This is nearly universal in many modern societies but has a great degree of variance of the deficiency and this is also regional (so, illuminating a possible cause of difference in seroprevalence/asymptomatic studies). Unequivocally, Vit D deficiency is known to be greatly immune-compromising and this increases with degree, being one of the basic building blocks of the human immune system. (It's lead to some questioning if this has been a viral pandemic so much as immune-deficiency pandemic. Which seems a reasonable proposition if indeed there do exist a large percentage of people whom have immune systems apparently capable of easily fighting off COVID.) A good summary of present COVID-19 Vit-D research: https://vitamind4all.org/letter.html https://vitamind4all.org/letter.html
- GekkePrutser 6y agoI'm surprised they still bother. I think with all the concerns surrounding it it's better to just agree to cancel the contracts and move to better vaccines. The mRNA ones in particular seem to work a lot better with less issues. Or perhaps this is the goal of the lawsuit? I would assume AstraZeneca would object to cancelling the contract even though they're not delivering on schedule. Perhaps they're planning to use this as leverage.
- cmrdporcupine 6y agoThe mRNA vaccines are much more expensive both in procurement and in handling, requiring more stringent refrigeration. AZ was supposed to be the "long tail" vaccine that could be produced for $2-$5 a dose and stored in regular refrigeration. It has great promise, hopefully the supply issues can be worked out.
- GekkePrutser 6y agoThe extreme refrigeration requirement for Pfizer was dropped: https://arstechnica.com/science/2021/02/pfizer-vaccine-rollout-might-get-a-lot-easier-ultra-cold-storage-not-required/ https://arstechnica.com/science/2021/02/pfizer-vaccine-rollo... But yes they are more expensive. Still, I'd gladly pay that for a better vaccine even if I had to pay it myself.
- the-dude 6y agoWhat makes the other vaccines better than the AZ one?
- cavisne 6y agoIt's amazing how much more successful the strategy in the US for vaccines was (even against rich countries). I assumed the rest of the world was following a Warp Speed style approach (multiple candidates, ramping manufacturing pre approval). Did the rest of the world simply bet that vaccines would be coming 12 months later?
- fsh 6y agoI would guess that the size of the pharmaceutical industry relative to the population is the main factor.
- cmrdporcupine 6y agoThe US restricted exports to the rest of the world. And most of the rest of the world has no production. They left their continental allies / neighbours high and dry and relying on Europe for exports, and Europe trying to behave nicely and share. The full bore of the US's pharma manufacturing industry was dedicated 100% to its own population. So yeah. Successful. After 30 years of continental economic integration, free trade agreements, and abandonment of local economic planning, selling off of Canadian pharma manufacturing, Reagan and Mulroney singing "Irish Eyes Are Smiling", etc. Canada could not rely on the US to buy exports of vaccines.
- PoignardAzur 6y agoHence the saying, "Never go into a well if all you have is american rope." I'm really hoping Europe doesn't forget that now that Biden is in office.
- cmrdporcupine 6y agoYeah I'm hoping Canada maintains some memory here, too. Biden kept in place Trump's vaccine export restrictions. But Trudeau and Biden have a better personal relationship, so we've gotten a bit of charity dusting from them. 1.5M (like... a week's supply) AZ that they couldn't use and was expiring, from a factory that it turned out had quality control issues... Hooray!
- libertine 6y agoThis is the only logical outcome - a sad one, but still. A lot of people paint AstraZeneca endeavor as something altruistic, and that such action of suing them would prevent other companies from doing this type of deal in the future... Regarding the altruism: in my eyes, this is a private company that got enough public funding (upfront) to expand their production capacity, and diluted that in the cost of vaccines sold. So they're selling vaccines at "cost", yet that production expansion is factored in that cost. Not to mention they got privileged access to publicly funded IP. Also, no one pressed them to sell it at cost, they could have sold for profit and pay/raise funding for production expansion, I doubt any country would complain about that. Regarding the "no company would do this type of deal again": good! We don't need companies that get free expansion and IP with the promises of delivery, just to find out they won't deliver. And the problem is not even the "not delivering", but being elusive about it. In fact, elusive about everything - from contracts they signed knowing they'd be overlapped and would compromise the deliveries of each other, to try move stock out to fulfill other contracts, to their apparent lack of action and communication to try to improve production yields, with no transparency at all. I mean, the CEO hasn't been seen in EU territory for a long, long time, and they literally ghosted the EU comission. In contrast, Pfizer CEO has been all over the place, reassuring they are trying their best to deliver and improve production. We were aware that production problems could, and most likely would, occur, but we weren't expecting how this company tried to deal with it. It sure as hell doesn't look like AZ did any "best reasonable effort", but that's for the court to decide.
- krona 6y agoThere were entirely separate supply chains. The one for the EU failed because the EU demanded it was in the EU (because 'solidarity') and the yields weren't sufficient. Then the EU demanded doses to be supplied from other supply chains because 'the contract blah blah' even though the EU has no legal leg to stand on; the commission is looking for a scapegoat and it thinks it has found one.
- libertine 6y agoFrom my understanding, they weren't entirely separate supply chains, since the contracts featured plants in the UK, just like the UK had plants in EU to fulfill their contract. You're saying yields weren't sufficient when some plants weren't even submitted for EMA approval until late March 2021, that's few weeks ago. And looks like it was submitted after the EU pressured them to, or let's say, when it came to light. Which was quite convenient because such vaccines wouldn't be subject to export controls. If they have no legal leg, why are they sueing? To show the world they lost a case lol... if they are suing they feel like they have a clear case.
- dageshi 6y agoThe only company operating at cost to provide vaccines ends up being the whipping boy, no charitable deed goes unpunished eh.
- maxerickson 6y agoDelivering at a low, agreed upon price is a better deed than not delivering on a lower, agreed upon price. These vaccines are all worth much more per dose than they are being sold for, comparing $5 to $10 and not to the value delivered makes it seem like $10 is a high cost, and it isn't.
- Mvandenbergh 6y agoPrediction based on a discussion I had with an experienced contract litigator based in Belgium (this will be under Belgian law): It's hard to predict how any court proceeding goes but the European Commission will probably lose this. Why? Considering how badly behind they are on their deliveries? Simply, the best available efforts structure of the contract gives them an extremely high bar to clear to succeed in this action. The fundamental problem AZ has had is that their yields from their bioreactors has been lower than anticipated and they haven't been able to increase them as fast as they had hoped. Yields of biologicals is essentially a black art as much as a science, batches can vary by orders of magnitude even in well characterised and mature processes (i.e. not this one). It's very much not like small molecule chemistry where it's all much more deterministic. From the litigation point of view then, if AZ shows that based on their own experts in production, they had made reasonable efforts to size the production facilities correctly in order to meet their agreed delivery schedule, it becomes almost impossible to show that they had not made "best reasonable efforts". This is why most contracts are not structured like that. Normally all that risk sits with the producer and they just have to develop a sufficiently good understanding of their process and how its yield can vary to hold enough inventory at intermediate and end-stages to buffer variations. In this case though, there was no choice, since there was no time to characterise a scaled up production process. They had to guess on the needed bioreactor capacity. If the EC wants to win this, they will have to show that this estimation was not just empirically wrong (obviously it was) but that it was sufficiently badly estimated procedurally that it constituted breach of the contract. This is also why claims about the UK somehow having a better contract are much too simple. The UK's contract was also best available efforts and in-fact the UK's order is by some measure even more delayed than the EU order (was originally 30m doses by September... 2020 and 100m by end of 2020). What is true is that months before the sales contracts were finalised, the UK had spent quite a lot of money through the University of Oxford on starting production scale-up in factories in the UK. Those factories had production contracts either with Oxford Biomedica or with the UK government some of which may have been novated across to AZ when they were selected as production partner. However the EU also spent quite a lot of money before finalising its purchase contracts including some on scale-up. Without a really in-depth understanding of what was spent where, and when, it is impossible to determine exactly how all these agreements relate to each other but anyone who wants to talk to you about the date that "the contract" was signed either doesn't know what they're talking about or is lying to you because there is no singular contract, this is a sequence of complicated agreements for research, scale-up, and production which is capped off in each case by a formal advanced purchase agreement. I think it is worth incidentally considering how incredibly lucky we've collectively been on the vaccine front. Essentially because of how well Moderna and particularly BionTech/Pfizer's vaccines have performed, people now seem to think that we were collectively owed vaccines of this quality and quantity by the universe and that AZ is somehow uniquely incompetent at not delivering something so simple. The reality is that some of the world's most experienced vaccine producers, Merck and the collaboration of Sanofi/GSK complete failed to produce working vaccines. Merck's recombinant rVSV vector performed poorly during trials, Sanofi messed up their dosing and is having to redo trials. CureVac still hasn't released P3 data, NovaVax has but hasn't got regulatory approval yet, J&J filed for approval relatively late and has also had a pretty significant production problem (albeit not a factory under their control). Instead of looking at AZ's production problems as some unbelievable outlier event, it makes more sense to recognise it as one particular event within a continuum of possible events in a very difficult context.