Coronavirus

[1andrew1]

Originally Posted by Damien

I guess we'll find out.

It's extraordinarily aggressive. A few posts ago I suggested that, so long as our supplies are not impacted, the U.K. Government has little reason to get involved but if the EU are going after a British/Swedish company to this extent out of spite or to cover their own failings then we might have too.

Maybe AstraZeneca have screwed up something here but raiding their offices seems extreme.

Minor point of accuracy - AstraZeneca's offices are not being raided, it's a Belgium contractor's factory that manufacturere the vaccine that is being raided.

In other news, Germany is recommending over-65s are not given the AstraZeneca vaccine.
https://www.theguardian.com/world/li...0847b489d2b7d7

[jfman]

Originally Posted by nomadking

The UK funded the development at Oxford.

Yes, but that’s a leap from the EU getting vaccines “courtesy of the UK”. They get vaccines (or don’t in this case) because they pony up to a pharmaceutical company.

Originally Posted by 1andrew1

Minor point of accuracy - AstraZeneca's offices are not being raided, it's a Belgium contractor's factory that manufacturere the vaccine that is being raided.

In other news, Germany is recommending over-65s are not given the AstraZeneca vaccine.

Germany's decision regarding the AZ vaccine is perverse, given how far behind they have got with vaccinating their population. It's true that older patients are under-represented in the trial data; this is because the trials were done by Oxford University, which operates to an academic ethical research policy that states you don't give trial drugs to older people until its safety and efficacy is proven among younger, fitter test subjects. This resulted in fewer older trial participants than might have been the case had AstraZeneca handled the process themselves from start to finish. However, there is no data to suggest its efficacy drops off so dramatically that it ought not to be used in older patients. This looks like another incidence of vaccine nationalism to me - bigging up the reputation of the Pfizer-Biontech vaccine that is at least part-German.

[nomadking]

Originally Posted by jfman

Yes, but that’s a leap from the EU getting vaccines “courtesy of the UK”. They get vaccines (or don’t in this case) because they pony up to a pharmaceutical company.

If the UK hadn't funded it, it might not have been available or certainly not at this stage.

---------- Post added at 14:46 ---------- Previous post was at 14:46 ----------

I wonder what the legal basis for the raid was meant to be. They're throwing one enormous hissy fit.
Perhaps this is why.
Link

Germany is likely to face a shortage of coronavirus vaccines until at least April, the country's health minister has warned.
"We will still have at least 10 tough weeks with a shortage," Jens Spahn wrote on Twitter.
...
It took workers there just days to construct a huge vaccination centre. Inside there are widely spaced chairs, pot plants and rows of private cubicles where doses can be administered.
But, owing to recent supply and production issues, there are no vaccines. The centre - where staff could administer up to 1,200 doses a day - is still empty.

[jfman]

Originally Posted by nomadking

If the UK hadn't funded it, it might not have been available or certainly not at this stage.

---------- Post added at 14:46 ---------- Previous post was at 14:46 ----------

I wonder what the legal basis for the raid was meant to be. They're throwing one enormous hissy fit.
Perhaps this is why.
Link

Someone else may have funded it? Who knows what would have happened. But the EU, if they get any, get it because they pay money for a product just like any customer/supplier transaction in the marketplace.

[1andrew1]

This is the announcement of the AstraZeneca deal with Europe:
https://www.astrazeneca.com/media-ce...no-profit.html

Here is the redacted Curevac contract which is in the public domain. Probably the closest we can get to at this stage as to what the AstraZeneca one will have looked like.
https://ec.europa.eu/info/sites/info...greement_0.pdf

Originally Posted by 1andrew1

This is the announcement of the AstraZeneca deal with Europe:
https://www.astrazeneca.com/media-ce...no-profit.html

Here is the redacted Curevac contract which is in the public domain. Probably the closest we can get to at this stage as to what the AstraZeneca one will have looked like.
https://ec.europa.eu/info/sites/info...greement_0.pdf

Paragraph I appears to be key.

The development, production, advance sale and supply of the Product as per this APA require significant investments by the contractor to increase the speed of vaccine research and development and clinical trials and the preparation of the at-scale production capacity along the entire production value chain in the EU required for a rapid deployment of the millions of doses of the Product. The Commission as well as the participating Member States are willing to contribute to financing of those investments in the form of up-front payments.

If there's an equivalent clause in the AstraZeneca contract, then that is what Pascal Soirot is referring to when he insists that it is development of capacity within the EU, that has occurred since the AZ/EU contract was signed, and funded with money from the EU, that is to be used to supply the EU. These newer facilities are the ones that are still having the bugs worked out of them and are therefore not going to allow AZ to deliver as much vaccine to the EU as the EU wants.

The EU yesterday tried to insist it has a stake in the UK facilities because its money helped to develop them. AstraZeneca appears to refute this. It will be interesting to see if the EU continues to press that point, because it will get very political very quickly if the EU and the UK governments have to argue in public over whether the plants in Oxford, Keele and Wrexham were tooled up with British or European money.

*If* Paragraph I is taken to mean that AZ undertook to develop facilities with EU money only after it signed a contract with the EU, and if EU funding was indeed only spent on new facilities in Belgium and elsewhere in the EU (and, notably, *not* on further developing facilities within the UK) then paragraph L holes the EU case below the waterline:

The participating Member States acknowledge that, in light of the uncertainties both with respect to the development of the Product and the accelerated establishment of sufficient manufacturing capacities, the delivery dates set out in this APA are the contractor's current best estimates only and subject to change. Due to possible delays in the authorisation, production and release of the Product, no Product or only reduced volumes of the Product may be available at the estimated delivery dates set out in this APA. In the case of delays to the anticipated availability of the Product, the contractor aims to allocate the doses of the Product fairly across the demand of doses, which the contractor has or will contractually commit to towards its present and future customers, as such doses become available.

It's there in black and white. This is a contract committing the manufacturer to 'best estimates only and subject to change.' If AstraZeneca has this same basic agreement then the EU hasn't got a leg to stand on, unless it can prove that its development money has been spent in the UK. Perhaps this is why they've been raiding facilities today. They need a paper trail.

Of course, whether they will find one is highly debatable. AstraZeneca's press release last June announcing the deal with the EU was quite explicit about its strategy for developing complete supply chains in each major territory where it signs a deal:

Pascal Soriot, Chief Executive Officer, said: “This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval. With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly. I would like to thank the governments of Germany, France, Italy and the Netherlands for their commitment and swift response.”

So when Soirot gave that interview to La Repubblica this week insisting that AstraZeneca developed facilities within the EU in order to supply vaccine to the EU, he wasn't retconning company strategy. This is what they said they were doing, nearly 7 months ago.

I really think the EU is sunk here.

[Pierre]

It's fascinating, this is a bigger deal that it really should be because what is actually happening is that the EU are losing face big time and that is their concern much more over and above that actual roll out of the vaccine.

In the sky news article I just read it does state

Sky News understands that AstraZeneca has agreed to publish its supply contract with the EU.

So obviously AZ are a bit pissed of at being badmouthed by the EU and are going to defend themselves.

And if it is a similar contract as the posted above, the EU are going to lose more face.

They should really focus their efforts in supporting the AZ facilities in the EU to get up to speed rather than being envious at what may be happening in a 3rd country!

[jonbxx]

David Allen Green has had a bit of a dive into the language used by AZ and the EU to see if we can understand where the issue in which is interesting - https://davidallengreen.com/2021/01/...ply-agreement/

My gut feeling? AZ sales signed up to something that manufacturing couldn't deliver either through enthusiasm or poor information. Buyers know that the demand will potentially outstrip supply and will do their damnedest to get clauses into contracts to secure their supplies. See it all the time in my industry - a jewellers eyepiece needed to go through those contracts and a wide view is needed to see what impact each contract will have on all the other ones you have on the go.

What's somewhat worse for the EU than their unified vaccine strategy going mammaries perpendicular is that the UK's is going swimmingly. The EU doesn't have any role, based in treaty, for this sort of action, and the last time there was a need for extra-treaty intervention (the financial crisis and Greek implosion) it took a lot of haggling and summitry to bring it about. This time of course the EU was smarting over Brexit and latched on to the vaccine procurement programme as a means of demonstrating the power of European unity. They have achieved the exact opposite.

---------- Post added at 16:56 ---------- Previous post was at 16:46 ----------

Originally Posted by jonbxx

David Allen Green has had a bit of a dive into the language used by AZ and the EU to see if we can understand where the issue in which is interesting - https://davidallengreen.com/2021/01/...ply-agreement/

My gut feeling? AZ sales signed up to something that manufacturing couldn't deliver either through enthusiasm or poor information. Buyers know that the demand will potentially outstrip supply and will do their damnedest to get clauses into contracts to secure their supplies. See it all the time in my industry - a jewellers eyepiece needed to go through those contracts and a wide view is needed to see what impact each contract will have on all the other ones you have on the go.

I think it's very unlikely that the contract in this case was worked up by sales reps working in isolation from the manufacturing arm of the business (though I have been mired in those sorts of situations often enough). Given the gravity of the situation, this has got to have gone to the very top, where there are board members with oversight of the relevant parts of the business and the ability to answer questions as to the feasibility of what's being demanded.

In D A Green's analysis it still comes back to whether or not AstraZeneca's existing capacity in the UK can be regarded as part of the capacity from which it is obliged to deliver product to the EU. One comment from the EU that he seems to have missed is their attempt to claim that EU development funds have been used in the UK. This suggests to me that the EU thinks it can only claim a share of UK product on the basis that they helped fund its manufacture - i.e. the poduct's mere existence as part of AstraZeneca's capacity to supply is not enough.

[Pierre]

Originally Posted by Chris

In D A Green's analysis it still comes back to whether or not AstraZeneca's existing capacity in the UK can be regarded as part of the capacity from which it is obliged to deliver product to the EU. One comment from the EU that he seems to have missed is their attempt to claim that EU development funds have been used in the UK. This suggests to me that the EU thinks it can only claim a share of UK product on the basis that they helped fund its manufacture - i.e. the poduct's mere existence as part of AstraZeneca's capacity to supply is not enough.

This is key.

Was EU money used only to set up & develop the facilities in the EU only. If so then there is no argument or claim to be had from the EU.

IF AZ did use UK & EU money to set up production in the UK, EU could claim a % of the output based on a % of funding.

This will rattle on for a while, lawyers will be licking their lips, but it won't get resolved quickly and I would hope that at the speed we're going we'll have all had our shots from one of the many vaccines in the pipeline by the time it's resolved.

Originally Posted by Pierre

This is key.

Was EU money used only to set up & develop the facilities in the EU only. If so then there is no argument or claim to be had from the EU.

IF AZ did use UK & EU money to set up production in the UK, EU could claim a % of the output based on a % of funding.

This will rattle on for a while, lawyers will be licking their lips, but it won't get resolved quickly and I would hope that at the speed we're going we'll have all had our shots from one of the many vaccines in the pipeline by the time it's resolved.

Pascal Soirot's interview to La Repubblica insisted that EU funds were only used in the EU. This is consistent with AstraZeneca's press release announcing the deal last June, in which it thanked those member states that had assisted with the establishment of facilities within the EU. Obviously that press release was made many months before this all blew up and can't be dismissed as obfuscation. Then, and now, AstraZeneca's position is that EU development assistance has only benefited its EU operations. And as the EU itself seems to believe that where its money was spent is the key to all this, sooner or later they're going to have to slink off and accept they screwed up.

[nomadking]

Originally Posted by 1andrew1

This is the announcement of the AstraZeneca deal with Europe:
https://www.astrazeneca.com/media-ce...no-profit.html

Here is the redacted Curevac contract which is in the public domain. Probably the closest we can get to at this stage as to what the AstraZeneca one will have looked like.
https://ec.europa.eu/info/sites/info...greement_0.pdf

Technically the agreement wasn't with the EU, but with certain EU countries. It was before the EU wide arrangement.
Elements of the EU supply chain were already in place, so can't have been EU funded.

With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly.

Cobra Biologics has been producing pharaceuticals for more than 20 years. It has two facilities on Keele University’s Science and Innovation Park making the vaccine in a partnership with the global pharmaceutical giant.

That site has been there for more than 20 years, so the EU cannot claim "ownership".
Other sites involved also were built before Covid surfaced.

Oxbox was originally built to solely service the Group’s growing demand for lentiviral vectors in the fast growing cell and gene therapy market where it is a leading global specialist working with multiple partners including Novartis, BMS and Sanofi. The Oxbox facility was completed at the end of 2019 with the Group expecting to have one or potentially two of the manufacturing suites approved during 2020. In April 2020 the Group joined the Oxford Vaccine Consortium and shortly afterwards signed the first of two agreements with AstraZeneca for COVID-19 vaccine production. By October 2020, the Group had four manufacturing suites approved by the MHRA, three of which were contracted by AstraZeneca and are currently producing bulk vaccine at 1000L scale.

Ian McCubbin, the manufacturing lead for the UK's Vaccine Taskforce said that the “vast majority” of the Oxford/AstraZeneca vaccine will be manufactured in the UK.
AstraZeneca also has some plants in Europe, with sites in Germany and the Netherlands producing the jab - these were the first to be rolled out in the UK.

The Belgian plant that was raided was opened in 2018, so again the EU cannot claim "ownership".


The Curevac agreement defines "reasonable best efforts" and that one factor is "yield of product". It also refers to "estimated delivery schedule", implying delivery dates are not to be set in stone.

Originally Posted by nomadking

Technically the agreement wasn't with the EU, but with certain EU countries. It was before the EU wide arrangement.
Elements of the EU supply chain were already in place, so can't have been EU funded.
That site has been there for more than 20 years, so the EU cannot claim "ownership".
Other sites involved also were built before Covid surfaced.

The Belgian plant that was raided was opened in 2018, so again the EU cannot claim "ownership".


The Curevac agreement defines "reasonable best efforts" and that one factor is "yield of product". It also refers to "estimated delivery schedule", implying delivery dates are not to be set in stone.

https://www.business-live.co.uk/ente...llion-18005904

Keele University Science Park-based Cobra Biologics and the Karolinksa Instituet - a world-leading medical university in Sweden - have teamed up in an attempt to develop a vaccine to COVID-19.

The organisations, which are part of the OPENCORONA consortium, have been awarded the emergency funding by Horizon 2020 for research and development and a phase one clinical trial testing of a DNA vaccine against coronavirus.

The aim of the project is to manufacture a DNA vaccine, which will be delivered to patient muscle to generate a viral antigen on which the immune system then reacts.

https://f.hubspotusercontent30.net/h...-Biologics.pdf

If that’s the basis on which the EU is claiming to have funded AstraZeneca’s production infrastructure in the UK, that is an extremely tenuous pretext indeed.