Vaccine Progress, Approval, and Deployment

[35B]

And do we believe that EU countries (and come to think of it, any other countries with vaccine production facilities) haven't inserted "nationalistic" clauses in their contracts ? It's notable that Pfizer has also had production problems, yet these don't seem to have attracted so much political attention.

Arguably the whole point of having on-shore production is to have some element of supply chain assurance, and this situation hasn't been been caused by the UK not pulling its weight, these are the continents facilities that aren't up to speed.

Yes, we should assist our neighbours - particularly once our vulnerable have been vaccinated -(which would be assisted by not persisting with a stupid lockdown strategy) however we should resist any narrative that we have taken an unduly nationalistic position. Afterall, was Germany being nationalistic last year when it had all of the testing capacity ?

The EU were slow to place orders, and are being slow to approve usage. They're comparing poorly to other places with their electorates, and need to find a way to look like they're doing something. That means they're throwing their weight around.

There are various extracts of the contract circulating online, and like any large commercial contract I've ever seen, the extracts make little sense in isolation and are correspondingly hard to interpret. The little I've seen suggests that the balance is in favour of AZ, but that in reality the EU and AZ have a choice of either getting into a fight where both will lose, or starting to act like grown ups to see how the situation can be improved.

 

[hwl]

The EU has a contract with Astra-Zeneca, which they believe gives a binding commitment to provide a certain level of output, with the output coming from a number of named factories including those in the UK. Astra-Zeneca claims that the commitment is a best-effort commitment. AZ are currently using the entire UK output to meet their contract with the UK government because they believe that this commitment is more binding. The EU believe this is not what was agreed.

If the contract dispute goes the EU's way rather than AZ's, then AZ would have to start providing supplies from the UK, which the UK may decide to prevent. The immediate downside of that is that the EU would probably block supplies for second injections of Pfizer.

More importantly thought, our vaccination efforts are running far ahead of most of the world, and we have pointlessly tied ending lockdown to vaccinating a lot of not-especially-vulnerable people. It will be a very bad look if we start restraining international trade in order to support the rollout to our not-very-vulnerable, whilst condemning European pensioners to "dying on a ventilator, hun".

It's not just the EU, who we urgently need to have some more negotiations with if we are going to avoid destroying our export industries. It's the rest of the world who will see us as basically an international pariah state.

Having read the document I do wonder if the senior EU people kicking up a fuss have:
a) read the document
b) legal training
c) a good grasp of the English language

WHEREAS, to combat the current COVID-19 global pandemic (the “COVID Pandemic”), AstraZeneca has partnered with Oxford University to rapidly clinically evaluate and scale-up global manufacturing of the Vaccine.
WHEREAS, AstraZeneca has accelerated its manufacturing scale-up concurrently with its conduct of global clinical trials to ensure the broadest possible availability of the Vaccine, as quickly as possible.
WHEREAS, as part of that scale-up, AstraZeneca has committed to use its Best Reasonable Efforts (as defined below) to build capacity to manufacture 300 million Doses of the Vaccine, at no profit and no loss to AstraZeneca, at the total cost currently estimated to be Euros for distribution within the EU (the “Initial Europe Doses”), with an option for the Commission, acting on behalf of the Participating Member States, to order an additional 100 million Doses (the “Optional Doses”).
WHEREAS, AstraZeneca will supply the Initial Europe Doses to the Participating Member States according to the terms of this Agreement.

If it is at no profit or loss to AZ and you pay a low price then you have prioritised getting it ASAP. (Oops)

5. Manufacture and supply.

5.1 Iniital Europe Doses. AstraZenaca shall uses use Best Reasonable Efforts to manufacture the Initial Europe Doses within the EU for distribution, and to deliver to distribution hubs...

The only reference in it to "Binding" is the final allocation between country who want to take up their quota (or not).

8.3 Allocation.
(a) No later than following the Effective Date, the Commission shall deliver to AstraZeneca a final and binding written allocation of Initial Europe Doses between the Participating Member States (the “Binding Allocation”), which Initial Europe Doses must equal 300 million. The number of
Initial Europe Doses set forth in the Binding Allocation shall be the total number of Initial Europe Doses that each Participating Member State is required to purchase pursuant to this Agreement.

 

[yorksrob]

The EU were slow to place orders, and are being slow to approve usage. They're comparing poorly to other places with their electorates, and need to find a way to look like they're doing something. That means they're throwing their weight around.

There are various extracts of the contract circulating online, and like any large commercial contract I've ever seen, the extracts make little sense in isolation and are correspondingly hard to interpret. The little I've seen suggests that the balance is in favour of AZ, but that in reality the EU and AZ have a choice of either getting into a fight where both will lose, or starting to act like grown ups to see how the situation can be improved.

Perhaps it would be better for them to go to court so that the whole affair can be scrutinised.

 

[Simon11]

I believe that the UK should continue with its current policy to focus on our vulnerable first, considering that we have a really bad death rate.

Once we have achieved this, we should definitely reduce our vaccination levels if required and redistribute some vaccines to countries which are currently facing high death rates and lacking vaccinations. Note that I agree that we should support countries with high levels of deaths but rather give them broadly to the EU or Africa, lets make the best use of these to reduce death rates and hospitalisations and focus on specific countries.

 

[HSTEd]

J&J vaccines results are in.

Only ~66% effective in preventing infection, but for first four weeks 85% reduction in hospitalisation/death, and beyond that protection against hospitalisation is complete.

 

[Yew]

J&J vaccines results are in.

Only ~66% effective in preventing infection, but for first four weeks 85% reduction in hospitalisation/death, and beyond that protection against hospitalisation is complete.

That'll do!

 

[YorkshireBear]

J&J vaccines results are in.

Only ~66% effective in preventing infection, but for first four weeks 85% reduction in hospitalisation/death, and beyond that protection against hospitalisation is complete.

It will do. Isn't that a similar level to AZ?

It's clearly now production not can we come up with vaccines that will hold the job up now.

 

[Chester1]

It will do. Isn't that a similar level to AZ?

It's clearly now production not can we come up with vaccines that will hold the job up now.

Slightly worse than AZ but still good news. Its hospitalisations and deaths that matter, not people getting a bit ill.

 

[Nicholas Lewis]

Ultimately though the human race is all in this together if we want to get back to anything near we had. The EU have there issues as do we over death rates very few are coming out of this well even gold plated NZ is looking fragile again. Basically we doubled down on the vaccines at a huge cost and whilst thats paid off there will still be a day of reckoning over paying for it. Mind you I can see us being able to donate to poorer countries soon to assist but this crowing from the hills by our politicians isn't going to endear us to our EU neighbours who we are still very reliant on for food!!

 

[Bertie the bus]

I believe that the UK should continue with its current policy to focus on our vulnerable first, considering that we have a really bad death rate.

Once we have achieved this, we should definitely reduce our vaccination levels if required and redistribute some vaccines to countries which are currently facing high death rates and lacking vaccinations. Note that I agree that we should support countries with high levels of deaths but rather give them broadly to the EU or Africa, lets make the best use of these to reduce death rates and hospitalisations and focus on specific countries.

No. Let’s not give anything to anybody. AstraZeneca isn’t the UK and the UK isn’t AstraZeneca. If the EU have a problem with a (partially) UK company we, as a country, have no moral or legal obligation to help them out. We also have contracts with the vaccine producers and I can’t for the life of me see how ours are less valid then somebody else’s. If the French developed vaccines hadn’t been a failure do you think they would prioritise us?

Your comment regarding Africa might have some merit if it was true. Africa doesn’t have a high death toll from COVID and my understanding is they do have some vaccines but they are having serious problems distributing and injecting it. Just giving them more to stockpile before they have solved their logistical problems would achieve nothing and would be to our detriment.

 

[Bantamzen]

No. Let’s not give anything to anybody. AstraZeneca isn’t the UK and the UK isn’t AstraZeneca. If the EU have a problem with a (partially) UK company we, as a country, have no moral or legal obligation to help them out. We also have contracts with the vaccine producers and I can’t for the life of me see how ours are less valid then somebody else’s. If the French developed vaccines hadn’t been a failure do you think they would prioritise us?

Your comment regarding Africa might have some merit if it was true. Africa doesn’t have a high death toll from COVID and my understanding is they do have some vaccines but they are having serious problems distributing and injecting it. Just giving them more to stockpile before they have solved their logistical problems would achieve nothing and would be to our detriment.

We have no moral obligation? Really? Batten down that hatches and stuff the rest? Regardless of how you feel about this situation, vulnerable people around the world are still people, regardless of what country they come from. Once we have taken care of ours, why would we not want to help people elsewhere that are most likely to suffer badly?

 

[Chester1]

Ultimately though the human race is all in this together if we want to get back to anything near we had. The EU have there issues as do we over death rates very few are coming out of this well even gold plated NZ is looking fragile again. Basically we doubled down on the vaccines at a huge cost and whilst thats paid off there will still be a day of reckoning over paying for it. Mind you I can see us being able to donate to poorer countries soon to assist but this crowing from the hills by our politicians isn't going to endear us to our EU neighbours who we are still very reliant on for food!!

The Government has no choice but to continue its current vaccination plan and get every adult their first dose by September. They have spent a year persuading young healthy people its a serious risk and consequently telling them they will have to wait longer than necessary isn't an option.

Israel is now vaccinating young healthy people. They are not receiving severe international pressure to stop. Some people are desperate to see the UK as weak. The 2 million doses a week in UK AZ contract will be delivered, with export bans if necessary (losing smaller Pfizer deliveries in the process). We have enough domestic capacity to do everyone before the Autumn.

Look at the talk of vaccine passports for various jobs, locations events and travel. Holding off vaccinating younger people won't politically be an option, regardless of the morality of it.

 

[rd749249]

5.1 of that EU/AZ document seems pretty clear cut to me. Manufacture and distribution within the EU. So any manufacture in the UK is not enforceable.

 

[Bertie the bus]

We have no moral obligation? Really? Batten down that hatches and stuff the rest? Regardless of how you feel about this situation, vulnerable people around the world are still people, regardless of what country they come from. Once we have taken care of ours, why would we not want to help people elsewhere that are most likely to suffer badly?

No we don't have a moral obligation. None at all. Vaccines aren't 100% effective and not all of the vulnerable people will have for for one reason or another. That is why everybody keeps going on about herd immunity. Once that is achieved then the vulnerable will have adequate protection but that certainly won't be achieved by just vaccinating the top 4 groups and won't be for months. Germany won't even be using the AZ vaccine on their most vulnerable so your argument holds no water whatsoever.

 

[35B]

Perhaps it would be better for them to go to court so that the whole affair can be scrutinised.

I think that would be considered a "lose lose" situation.

5.1 of that EU/AZ document seems pretty clear cut to me. Manufacture and distribution within the EU. So any manufacture in the UK is not enforceable.

Which is where you need to be careful - 5.4 defines the UK as within the EU for the purposes of defining where manufacturing sites are located.

No we don't have a moral obligation. None at all. Vaccines aren't 100% effective and not all of the vulnerable people will have for for one reason or another. That is why everybody keeps going on about herd immunity. Once that is achieved then the vulnerable will have adequate protection but that certainly won't be achieved by just vaccinating the top 4 groups and won't be for months. Germany won't even be using the AZ vaccine on their most vulnerable so your argument holds no water whatsoever.

And it's because the vulnerable aren't just in the UK that the obligation to consider the wider world does exist. There's a question of timing, and of precisely how, but the question "who is my neighbour" has as much force now as it did when asked 2000-odd years ago.

 

[Bantamzen]

No we don't have a moral obligation. None at all. Vaccines aren't 100% effective and not all of the vulnerable people will have for for one reason or another. That is why everybody keeps going on about herd immunity. Once that is achieved then the vulnerable will have adequate protection but that certainly won't be achieved by just vaccinating the top 4 groups and won't be for months. Germany won't even be using the AZ vaccine on their most vulnerable so your argument holds no water whatsoever.

I believe as humans we have an obligation to all humans, not just the ones we pick out as more important.

"All animals are equal, but some animals are more equal than others".

 

[takno]

No. Let’s not give anything to anybody. AstraZeneca isn’t the UK and the UK isn’t AstraZeneca. If the EU have a problem with a (partially) UK company we, as a country, have no moral or legal obligation to help them out. We also have contracts with the vaccine producers and I can’t for the life of me see how ours are less valid then somebody else’s. If the French developed vaccines hadn’t been a failure do you think they would prioritise us?

Your comment regarding Africa might have some merit if it was true. Africa doesn’t have a high death toll from COVID and my understanding is they do have some vaccines but they are having serious problems distributing and injecting it. Just giving them more to stockpile before they have solved their logistical problems would achieve nothing and would be to our detriment.

I think that the logic is "we're a nasty piece of work, therefore all other countries are nasty pieces of work too, especially the French, therefore if we are horrible to them then they will deserve it because it was exactly what they were going to do to us". Feels just a bit toxic to me.

If you do want to think of it in terms of naked self-interest however, then just bear in mind that while we are self-sufficient in vaccine production, we are not self-sufficient in almost anything else. We need to trade, and in order to trade we need to be trusted. We are not currently setting ourselves on a path where we will be trusted. We could end up spending next year as the best-vaccinated starving people in the world.

 

[rd749249]

Which is where you need to be careful - 5.4 defines the UK as within the EU for the purposes of defining where manufacturing sites are located.

So I wonder if putting something that is factually not true into an agreement is also enforceable? We left the EU 31st Jan 2020.

 

[yorksrob]

There must be some sort of a compromise where we can genuinely be of assistance, without jettisoning our own vaccination programme. At the same time, there has to be a recognition that Europe is very big, and our contract isn't going to plug their hole anyway, so the real solution will be them getting their manufacturing in gear.

 

[Chester1]

There must be some sort of a compromise where we can genuinely be of assistance, without jettisoning our own vaccination programme. At the same time, there has to be a recognition that Europe is very big, and our contract isn't going to plug their hole anyway, so the real solution will be them getting their manufacturing in gear.

The obvious solution is that the UK blocks exports if AZ isn't meeting its contracted 2 million doses a week for the NHS but allows them to export everything in excess of that. That might mean they ship a few million doses worth of main content to EU for finish and bottling over next few weeks. Presumably the EU would do the same with Pfizer.

Its not our problem that the EU started the process 3 months after the UK and are consequently still having teething issues. They are essentially demanding that British people die to save European lives because they were incompetent. Call it nationalist if you want but no sane Government would agree to that.

 

[35B]

So I wonder if putting something that is factually not true into an agreement is also enforceable? We left the EU 31st Jan 2020.

Yes, because what it's actually saying is where factories can be located. It's a definition for the purpose of a contract (you could define "black" as white if you wanted), not a political reality.

 

[yorksrob]

The obvious solution is that the UK blocks exports if AZ isn't meeting its contracted 2 million doses a week for the NHS but allows them to export everything in excess of that. That might mean they ship a few million doses worth of main content to EU for finish and bottling over next few weeks. Presumably the EU would do the same with Pfizer.

Its not our problem that the EU started the process 3 months after the UK and are consequently still having teething issues. They are essentially demanding that British people die to save European lives because they were incompetent. Call it nationalist if you want but no sane Government would agree to that.

As long as our contract is being fulfilled, that sounds like a pretty reasonable compromise to me.

We shouldn't be penalised for getting our ducks in a row.

 

[brad465]

The obvious solution is that the UK blocks exports if AZ isn't meeting its contracted 2 million doses a week for the NHS but allows them to export everything in excess of that. That might mean they ship a few million doses worth of main content to EU for finish and bottling over next few weeks. Presumably the EU would do the same with Pfizer.

Its not our problem that the EU started the process 3 months after the UK and are consequently still having teething issues. They are essentially demanding that British people die to save European lives because they were incompetent. Call it nationalist if you want but no sane Government would agree to that.

I do think there is an irony that we're not keen to export goods (in this case vaccines), when one thing about Brexit was "supposed" to be about increasing trade and a past decrease in manufacturing creating EU resentment.

 

[rd749249]

Yes, because what it's actually saying is where factories can be located. It's a definition for the purpose of a contract (you could define "black" as white if you wanted), not a political reality.

6.2 appears to indemnify AZ against competing agreements if their best efforts in the Agreement hinder performance.

I think the EU case here is weak, save for how Belgian law interprets a lot of this but in English law, the notion of best efforts is not really used as it doesn’t provide any certainty.

 

[Chester1]

6.2 appears to indemnify AZ against competing agreements if their best efforts in the Agreement hinder performance.

I think the EU case here is weak, save for how Belgian law interprets a lot of this but in English law, the notion of best efforts is not really used as it doesn’t provide any certainty.

Its British law that matters as they want doses made in the UK. It doesn't matter if a Belgian court or the ECJ rule that AZ must ship doses from the UK if those doses are not allowed to leave the UK because it would mean the UK contract was not met.

The finish (the main ingredient needing padding out for it to be taken up) seems to be the main bottleneck in UK production. We can give them some of the main ingredient without having a significant effect on the UK contract. Its still not going to be close to the amount they are short by for the first quarter (49 million doses). The EU have to own its mistake at some point. Any retaliation they could attempt against the UK will easily be worth the cost to save 10s of thousands of lives in the next few months.

 

[Simon11]

The obvious solution is that the UK blocks exports if AZ isn't meeting its contracted 2 million doses a week for the NHS but allows them to export everything in excess of that. That might mean they ship a few million doses worth of main content to EU for finish and bottling over next few weeks. Presumably the EU would do the same with Pfizer.

Its not our problem that the EU started the process 3 months after the UK and are consequently still having teething issues. They are essentially demanding that British people die to save European lives because they were incompetent. Call it nationalist if you want but no sane Government would agree to that.

I kind of agree, but once we have vaccinated the vulnerable, with a very dodgy example assuming that every vaccination given after that may have 1% of a chance of saving that persons life from covid or preventing going to hospital. The alternative would be to offer that jab to another country who are still vaccinating the vulnerable but lacking vaccines and have a 5% chance of saving that life or preventing going to hospital. With that scenario, we should offer that jab to them in a heart beat as it will be five times more effective.

And another comment, if the shoe was on the other foot and the Oxford vaccinate had turned out to be useless. I think majority of the views here would be so different!

 

[hwl]

I think that would be considered a "lose lose" situation.

Which is where you need to be careful - 5.4 defines the UK as within the EU for the purposes of defining where manufacturing sites are located.

The rest of 5.4 is centered around using volume from non EU or UK to supply additional volume and the extra checks and authorisations needed for that. It looks like 5.4 was designed to cover the question of regulatory equivalence due to Brexit.

 

[Chester1]

I kind of agree, but once we have vaccinated the vulnerable, with a very dodgy example assuming that every vaccination given after that may have 1% of a chance of saving that persons life from covid or preventing going to hospital. The alternative would be to offer that jab to another country who are still vaccinating the vulnerable but lacking vaccines and have a 5% chance of saving that life or preventing going to hospital. With that scenario, we should offer that jab to them in a heart beat as it will be five times more effective.

And another comment, if the shoe was on the other foot and the Oxford vaccinate had turned out to be useless. I think majority of the views here would be so different!

The reverse applies to the EU. They wouldn't take a major hit to their program if the UK had messed up procurement. We would have been told it was our fault because of brexit.

I agree you are right on a rational level but politically its not viable to vaccinate the 20 million high risk Brits and leave the other 47 million unvaccinated to export the vaccine. It would go against everything the Government has said to under 50s since the pandemic began. It would mean severe restrictions for much longer or the virus running rampant amongst 2/3rds of the population. UK won't start exporting on a large scale until late summer.

 

[hwl]

if the shoe was on the other foot and the Oxford vaccinate had turned out to be useless. I think majority of the views here would be so different!

The UK has more different vaccine purchase options than the EU for that very reason.

The Oxford vaccine was quickly adapted from a MERS vaccine that had got thorough phase 2 trials already and was heading to phase 3.... Hence there was already a reasonable confidence level.
Novamax was big enough to get taken seriously in the US by "Warpspeed" but we supported them and it is paying dividends.

EU countries did very little to help trials.

 

[35B]

Its British law that matters as they want doses made in the UK. It doesn't matter if a Belgian court or the ECJ rule that AZ must ship doses from the UK if those doses are not allowed to leave the UK because it would mean the UK contract was not met.

The finish (the main ingredient needing padding out for it to be taken up) seems to be the main bottleneck in UK production. We can give them some of the main ingredient without having a significant effect on the UK contract. Its still not going to be close to the amount they are short by for the first quarter (49 million doses). The EU have to own its mistake at some point. Any retaliation they could attempt against the UK will easily be worth the cost to save 10s of thousands of lives in the next few months.

The contract between the EU and AZ will depend on the law of whichever jurisdiction that contract agrees will apply. The U.K. contract may or may not be relevant in a dispute there, depending on what the EU contract has to say about the priority of any other obligations AZ may have. I’d be surprised if AZ signed contracts that conflict, but it would be perfectly possible, in theory at least, for AZ to have contracts set up in a way that give them obligations to the U.K. that aren’t compatible with their obligations to the EU.

If AZ are in breach of their contract with the EU, how they fix that is a matter for them, not the British or any other government unless they ask that government to relax the terms of their contract to support fulfilling the EU contract. Though I doubt that AZ are in that position, they have voluntarily submitted in their contract with the EU to the jurisdiction of continental courts, and would be subject to whatever rulings they made.

6.2 appears to indemnify AZ against competing agreements if their best efforts in the Agreement hinder performance.

I think the EU case here is weak, save for how Belgian law interprets a lot of this but in English law, the notion of best efforts is not really used as it doesn’t provide any certainty.

If your reading is correct, then that is a very interesting position as it gives the EU substantial leverage to drive AZ to deliver the EU contract in preference to the U.K. one.

As for “best” or “reasonable” efforts, I find the concepts of “best endeavours” or “reasonable endeavours” regularly crop up in my professional work. They are ill defined, but with enough case law behind them that I would always be very careful about signing up to a contract using either term, especially “best endeavours” - a term that conveys no limit on how far that party must go to meet the obligation of the contract. “Reasonable endeavours” is something I have used from time to time to indicate where one party will work very hard to deliver an outcome, but without committing to delivery of that outcome; it always comes under massive scrutiny when I do and I therefore try to avoid it if at all possible.