Italian authorities discover 29M Oxford/AstraZeneca doses: La Stampa
politico.eu
politico.eu
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-...
- 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 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...
- 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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
The fact that EU is the only western entity that produces vaccines and where export is allowed makes it much more complicated.
And these guys shall now solve a problem for real despite having a track record of being unable to do so?
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 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.
https://www.politico.eu/article/breton-no-astrazeneca-jabs-e...
but this is still a guess at this point.
Did Moderna get more support from other companies/the government?
(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.)
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.
Must have been some contract...
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.
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.
Which makes the number found here really curios.
https://www.cnn.com/2021/03/04/europe/italy-astrazeneca-dose...
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...
Who is responsible for the approval? AFAIK the Brits have no problems with the Halix plant.
- 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 contract lists two factories in Britain, one in the Netherlands (Halix), one in Belgium. Another one in the United States is listed as a back-up supplier. Currently, only the plant in Belgium, run by Thermo Fisher Scientific, is producing shots for the EU.
The Commission has also started a procedure foreseen under the contract with AstraZeneca that could lead to legal action against the company.
The comment about COVAX is a general concern about EU export restrictions and not connected to the lots discovered.
https://www.nrc.nl/nieuws/2021/03/24/wie-krijgt-de-vaccins-u...
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'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.
Edit: nevermind, seems they didn’t even ask for approval.
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?
But the politics of it, absolutely.
are they not allowed to do that?
how long would a randomised controlled trial take?
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.
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.
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.
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.
There's absolutely no evidence at all supporting your allegations.
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
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.
https://www.niaid.nih.gov/news-events/niaid-statement-astraz...
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.
Yes, especially if you've never done vaccine production before!
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...
"[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...
- 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...
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...
Seems like a good call.
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.
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 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.
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.
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.
- 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.
And experience to date is that EMA has been more demanding than UK regulator.
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 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 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.
Good joke
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 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.