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I bet it's the same in many other countries. Thanks for highlighting this.
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EU and AstraZeneca
- Thread starter Neville's Breakfast
- Start date
I bet it's the same in many other countries. Thanks for highlighting this.
Baker lite
Banned
Are you at all surprised?
The mask has well and truly slipped off of this spiteful organisation. Thank goodness we are out and are free to keep our vulnerable safe.
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Yes, you are right, with some caveats. First, if Germany chooses to follow EU guidance, in accordance with the views of the EMA, that is up to them. We chose to continue to use our own regulators and were never obliged to deny approval of any medicine for domestic use, and never 'told' to do so by the EU. Never. We could have chosen to follow EU process if we wished but we were never obliged.
And there were no EU quotas on a vaccine that had not been approved. There were (since last summer) aspirations and commitments to disburse vaccines when they were available (links below). Rather different.
The EU were slow and we took a risk. So far so good for us, although if it turns out there are production issues with one of the vaccines approved early, and people die in the UK from a contaminant before EU members get a jab, the narrative will change; America never had the thalidomide scandal because they were slow to approve the drug in pregnancy whereas in the UK we went gung ho.
Looking at the EU website (https://ec.europa.eu/info/live-work...ublic-health/coronavirus-vaccines-strategy_en) it seems that the squabble is between the EU and the drug companies over fulfilment of contracts. None of our business, really. We have our own contracts. Shouty Greek politician can gob off, but she is doubtless just playing to her domestic gallery; nothing for us to see here. But I digress...
You point I assume is that if we were still in the EU we would have had to have gone along with the strategy in the link posted above. I disagree. We could have chosen to, or not. Same as with other medicines. I think the EU are being silly at the moment, if they start demanding vaccine be redirected from the UK to the EU. We have a contract. Anyway, time will tell....I see Gove is already gleefully telling the EU to sod off; not done a telly interview yet - probably waiting for his tumescence to subside
.The EU position with AZ appears to be as follows "Today's contract is based on the Advanced Purchase Agreement approved on 14 August with AstraZeneca, which will be financed with the Emergency Support Instrument. The “Inclusive Vaccine Alliance” countries (Germany, France, Italy, the Netherlands) who started negotiations with AstraZeneca asked the Commission to take over through an agreement signed on behalf of all Member States." see https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1524 So there may be an agreement signed by all the EU states, but this clearly would be an agreement (among states who agree); nothing to stop a state not agreeing if they wish. Nothing there about all member states agreeing to not pursue their own agenda, either. And there is also nothing there to say that EU states have priority over non EU states who may create their own arrangements (or indeed EU states).
That said I accept that had we still been in the EU we would probably have gone along with the rest (not certain - as stated earlier we have a process independent on EMA, and we also have an anti-EU government who may well have decided to make a point and go it alone) so maybe we have benefitted from not being in the EU. But this is nuanced. And it would have been better if we had been a bit more like Germany (who are in the EU last time I looked) and made a better effort to control the pandemic and not instead be the nation with the worst rate of cases and deaths (I nearly wrote 'in the EU', but we aren't are we? Schoolboy error.....).
Apologies if I have misunderstood anything . . . . actually I am not sure there has actually been any official EU demands or accusations, and I may be doing what the poor secretary at the GLC did late one Friday when the Sun rang her office and asked for a comment about the GLC banning 'Baa Baa Black Sheep' on grounds of racism.....
Uter
Well-known member
Interview with CEO of AZ in La Repubblica:
https://www.repubblica.it/cronaca/2...azeneca_coronavirus_covid_vaccines-284349628/
Mr Pascal Soriot, CEO of AstraZeneca, why hasn't AstraZeneca been more specific on detailing the supply problem detected on its European plants? What exactly is the problem?
“I think we have been relatively specific with the information. Of course, we are all very disappointed. We would like to produce more. I think we will deliver up to Europe in the month of February a reasonable quantity actually, very similar to what others have delivered on a monthly basis. But of course, it's less than expected and also because our vaccine is easy to use people expected more so we could scale up. Our team is working 24/7 to fix the very much issues of production of the vaccine itself. You have two steps in the production of a vaccine: one is you produce the vaccine itself. We call it a drug substance, the vaccine. Then, when we are finished with it, we move this into different plants where we put the vaccine into vials and we call that the drug product, the final product. For Europe the drugs substance is essentially produced in two plants, one in the Netherlands, one in Belgium. The drug product is actually produced in Italy and Germany. So from a drug product viewpoint, we have full capacity. We have zero problem. The current problems have to do with manufacturing the drugs substance”.
“So maybe I need to give you a little bit of explanation as to how we manufacture those vaccines. Essentially, we have cell cultures, big batches, 1000-litre or 2000-litre batches. We have cell cultures inside those batches and we inject them with the virus, the vaccine, if you will. Then those cells produce the vaccine, it’s a biotechnology protection. Now, some of those batches have very high yield and others have low yield. Particularly in Europe, we had one site with large capacity that experienced yield issues. So it's essentially a question of when you scale up to the level we are scaling up to - something like this that's never been done. We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed".
“A year ago, we didn't have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies from one to three, by the factor of three. The best site we have produces three times more vaccine out of a batch than the lowest producing site. We do this with a series of partners: in the US, those partners are actually approved by BARDA, the US administration, the group that manages those things and manages the capacity”.
"In the US, we also have issues of yield and essentially our engineers have worked with our partners to identify what the issues are. We believe we have sorted out the issues now. The issues are different, for instance, in Belgium: we believe it was more a question of downstream filtering because when you finish making the vaccine, you have to filter it. When you filter it, you put it into vials. Our partner in Australia for instance also had yield issues. And they have been in the vaccine business for 20 years. But it's complicated, especially in the early phase where you have to really kind of sort out all sorts of issues. We believe we've sorted out those issues, but we are basically two months behind where we wanted to be. We've had also teething issues like this in the UK supply chain. But the UK contract was signed three months before the European vaccine deal. So with the UK we have had an extra three months to fix all the glitches we experienced. As for Europe, we are three months behind in fixing those glitches. Would I like to do better? Of course. But, you know, if we deliver in February what we are planning to deliver, it's not a small volume. We are planning to deliver millions of doses to Europe, it is not small”.
You say that EU is going to receive a reasonable quantity of doses by February. Could you please quantify this?
"First of all, as soon as we get an approval by EMA, in the next few days, we will be shipping at least three million doses immediately to Europe, then we'll have another shipment about a week later and then the third or fourth week of February. And the target is to deliver 17 million doses by February. So, I am just estimating roughly, that would mean like about 3 million doses for Germany, probably 2,5 million for Italy and something like 2 million for Spain. I don't know exactly what the precise allocation is, but it's based on the population of each country. If you're in Germany, you can vaccinate three million people in one month. It's actually not so bad especially for the people who are the most exposed and most at risk. That's not a small proportion. And if you apply the three month regimen, then in March, you can do the same again or more potentially because we are working hard to increase our goals. It's not as good as we would like to, but it's really it's not so bad”.
So Europe signed the contract too late, instead of the UK?
“I will not pass judgment on this. But I can only tell you the facts and the facts are that we basically signed an agreement with the UK three months before we did have it with Europe. Now, part of this can be easily explained. When we entered the agreement with Oxford, they had already been working with the UK government on this. So they had a head start. We were able to quite quickly take the UK supply chain and improve it. We had to modify the formula in the process, because Oxford gave us a process that needed to be modified to enable manufacturing at scale. Just think about, we've done all of this in months. Usually, it takes years. We got a manufacturing process that Oxford gave us, which was producing a good vaccine, but not at an industrial scale. It was just able to produce quantities for clinical trials. So then we had to modify the process to turn it into a process that could manufacture billions of doses. At a cost that is reasonable and at a speed that is reasonable".
"We had to change all of these. Then we had to do what we call technology transfer. So we go to each partner and we train them on the process. We train them on how to manufacture. And then, you know, some people are new to this process. It's like they learn the process. They don't know how to make the vaccine and they're not as efficient as others".
"So you may have lower productivity. That's why we have a productivity going from one to three. And so, unfortunately, it's really bad luck. Actually, there's nothing mysterious about it. But look, the sites that have the lowest productivity in the network are the sites that are supplying Europe. And quite honestly, I mean, we're not doing it on purpose. I'm European, I have Europe at heart. Our chairman is Swedish, is European. Our CFO is European. Many people in the management are European. So we want to treat Europe as best we can. You know, we do this at no profit, remember? We didn't go into this to try and make money or whatever. We would like to treat Europe as good as possible. I actually do believe we treated Europe fairly".
"Now, let me give you another number. Our total capacity globally now is about 100 million doses a month. From February onwards we are able to make 100 million doses a month, that's not small. Most vaccines have 100 million doses a year, that already takes us on a 1,2 billion pace per year. We are going to keep growing. Of course, we are ramping up production and Europe is getting 17 percent of this global production in February for a population that is 5 percent of the world population. Now, from the beginning we took very seriously the approach that Europe took, which we thought was fair and we all took. In fact, the US didn't say that Europe said that. Europe said the vaccine is common good and everybody needs to get access at the same time globally. That's what we are doing. Europe is getting 17 percent of our global supply for a month for 5 percent of the world population. The problem is: 100 million doses is a lot, but we have 7,5 billion people in the world".
"We are in the ramp-up phase and basically it will improve, but it takes time. Having said all of this, I'm not looking for excuses, honestly. We take accountability. We want to do better and we're working day and night. Our people in manufacturing, we have hundreds of people, thousands of people now. Many of them didn't take any Christmas vacation. I'm not asking you feel sorry for us but you know, we're doing our very best. But it's a very complicated process and a big scale”.
After the explanation you just gave at the same time it is striking the aggressive way which the EU has responded, even threatening to impose a new control on exports of activity out of Europe. Some are suggesting that you're selling your product to some other countries.
“The suggestion we sell to other countries to make more money is not right because we make no profit everywhere. That's the approach we took and we agreed on that. That’s the agreement we have with Oxford University. It's actually even written in a contract we have with Oxford University: that we will be at no profit. We have slightly different prices from one geographic to the other because the cost of goods may be different. We have a supply chain in Brazil, we have another one in Latin America, another one in South Asia. We have one in Japan. Of course, you know, local costs are different. So you've got slight variations, but more or less, it's about three to four dollars, more or less everywhere. It makes no difference. Zero difference. I understand we all want to be vaccinated. I think the populations of Europe, like everywhere else in the world, have been under so much stress with this pandemic for so long now, for a year or so, that people are tired. And I think the people who didn't want to be vaccinated maybe six months ago are now saying: "I want to be vaccinated". You have a lot of people who want to be vaccinated".
"So, governments are under pressure. Everybody is getting kind of a bit, you know, aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe. We're certainly not taking vaccines away from the Europeans to sell it somewhere else at the profit. It would not make sense, honestly, if you think about it: we engaged in this process a year ago and we're going to make zero profit. It would not make sense for us to then say "we're going to make a profit somewhere else and destroy the whole spirit of the agreement". First of all, we would be in breach of the agreement we have with Oxford. Secondly, we've done it because we want to do it for the good of humankind".
You said that the UK signed the AZ vaccine contract three months before EU, so you had more time to tweak and fix the potential disruptions of the supply. Why then did you commit to similar contracts with the EU, if you knew that in a very short time there could be problems like the one the EU supply chain is experiencing right now?
"First of all, we have different plants and they have different yields and different productivity. One of the plans with the highest yield is in the UK because it started earlier. It also had its own issues, but we solved all, it has a good productivity, but it's the UK plant because it started earlier. Anyway, we didn't commit with the EU, by the way. It's not a commitment we have to Europe: it’s a best effort, we said we are going to make our best effort. The reason why we said that is because Europe at the time wanted to be supplied more or less at the same time as the UK, even though the contract was signed three months later. So we said, “ok, we're going to do our best, we’re going to try, but we cannot commit contractually because we are three months behind UK”. We knew it was a super stretch goal and we know it's a big issue, this pandemic. But our contract is not a contractual commitment. It's a best effort. Basically we said we're going to try our best, but we can't guarantee we're going to succeed. In fact, getting there, we are a little bit delayed”.
So is this the contract that the EU signed?
“Yes, certainly. Now we have a vaccine and everybody thinks it's easy. But in April last year, everybody was saying “it's impossible to do a vaccine by the end of the 2020”, or “you're going too fast” or “you're cutting corners”, “you can't do it”, et cetera. Now everybody is saying “you’re too slow”, while before we were “too fast”. At that time, when we talked about those things, first of all we didn't know whether we would have a vaccine or not. We didn't know what the yield would be. When you develop a vaccine, usually you do that over five, six years. We did this in a few months, so we thought, you know, if we are successful, we can get through this yield. Unfortunately, some manufacturing sites got to the yield and others didn’t. We knew that it was going to be very challenging. But if we had not stretched the process like this, maybe we would not even be able to produce vaccines now”.
Italy is one of the countries that have explicitly threatened legal action against AstraZeneca. However, from what you have been saying, there is no feasible basis for a potential legal action against AstraZeneca.
“I don't want to give judgment on anything that has been said. I can only tell you what's in their contract. And the contract is very clear. Our commitment is, I am quoting, “our best effort”. There are a lot of emotions running in this process right now, and I can understand it: people want vaccine. I want the vaccine too, I want it today. But, at the end of the day, it's a complicated process. We are getting there, in two or three months we will be at scale. We have a 17-million-dose production per month right now, it is actually not small at all. But of course, it’s less than people want and understandably so”.
Is there any chance that the contracts could be reconsidered in the sense that you may distribute the vaccines in some other way? For instance, would it be possible to take some of the vaccines destined for UK and move them to the EU or some other countries? Or is this such a fixed contract that you cannot change it?
“The UK agreement was reached in June, three months before the European one. As you could imagine, the UK government said the supply coming out of the UK supply chain would go to the UK first. Basically, that's how it is. In the EU agreement it is mentioned that the manufacturing sites in the UK were an option for Europe, but only later. But we're moving very quickly, the supply in the UK is very rapid. The government is vaccinating 2.5 million people a week, about 500,000 a day, our vaccine supply is growing quickly. As soon as we have reached a sufficient number of vaccinations in the UK, we will be able to use that site to help Europe as well. But the contract with the UK was signed first and the UK, of course, said “you supply us first”, and this is fair enough. This vaccine was developed with the UK government, Oxford and with us as well. As soon as we can, we'll help the EU. I mean, as a company we are half Swedish and half British. In fact, we're global, of course, but we are European as much as we are British".
https://www.repubblica.it/cronaca/2...azeneca_coronavirus_covid_vaccines-284349628/
Mr Pascal Soriot, CEO of AstraZeneca, why hasn't AstraZeneca been more specific on detailing the supply problem detected on its European plants? What exactly is the problem?
“I think we have been relatively specific with the information. Of course, we are all very disappointed. We would like to produce more. I think we will deliver up to Europe in the month of February a reasonable quantity actually, very similar to what others have delivered on a monthly basis. But of course, it's less than expected and also because our vaccine is easy to use people expected more so we could scale up. Our team is working 24/7 to fix the very much issues of production of the vaccine itself. You have two steps in the production of a vaccine: one is you produce the vaccine itself. We call it a drug substance, the vaccine. Then, when we are finished with it, we move this into different plants where we put the vaccine into vials and we call that the drug product, the final product. For Europe the drugs substance is essentially produced in two plants, one in the Netherlands, one in Belgium. The drug product is actually produced in Italy and Germany. So from a drug product viewpoint, we have full capacity. We have zero problem. The current problems have to do with manufacturing the drugs substance”.
“So maybe I need to give you a little bit of explanation as to how we manufacture those vaccines. Essentially, we have cell cultures, big batches, 1000-litre or 2000-litre batches. We have cell cultures inside those batches and we inject them with the virus, the vaccine, if you will. Then those cells produce the vaccine, it’s a biotechnology protection. Now, some of those batches have very high yield and others have low yield. Particularly in Europe, we had one site with large capacity that experienced yield issues. So it's essentially a question of when you scale up to the level we are scaling up to - something like this that's never been done. We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed".
“A year ago, we didn't have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies from one to three, by the factor of three. The best site we have produces three times more vaccine out of a batch than the lowest producing site. We do this with a series of partners: in the US, those partners are actually approved by BARDA, the US administration, the group that manages those things and manages the capacity”.
"In the US, we also have issues of yield and essentially our engineers have worked with our partners to identify what the issues are. We believe we have sorted out the issues now. The issues are different, for instance, in Belgium: we believe it was more a question of downstream filtering because when you finish making the vaccine, you have to filter it. When you filter it, you put it into vials. Our partner in Australia for instance also had yield issues. And they have been in the vaccine business for 20 years. But it's complicated, especially in the early phase where you have to really kind of sort out all sorts of issues. We believe we've sorted out those issues, but we are basically two months behind where we wanted to be. We've had also teething issues like this in the UK supply chain. But the UK contract was signed three months before the European vaccine deal. So with the UK we have had an extra three months to fix all the glitches we experienced. As for Europe, we are three months behind in fixing those glitches. Would I like to do better? Of course. But, you know, if we deliver in February what we are planning to deliver, it's not a small volume. We are planning to deliver millions of doses to Europe, it is not small”.
You say that EU is going to receive a reasonable quantity of doses by February. Could you please quantify this?
"First of all, as soon as we get an approval by EMA, in the next few days, we will be shipping at least three million doses immediately to Europe, then we'll have another shipment about a week later and then the third or fourth week of February. And the target is to deliver 17 million doses by February. So, I am just estimating roughly, that would mean like about 3 million doses for Germany, probably 2,5 million for Italy and something like 2 million for Spain. I don't know exactly what the precise allocation is, but it's based on the population of each country. If you're in Germany, you can vaccinate three million people in one month. It's actually not so bad especially for the people who are the most exposed and most at risk. That's not a small proportion. And if you apply the three month regimen, then in March, you can do the same again or more potentially because we are working hard to increase our goals. It's not as good as we would like to, but it's really it's not so bad”.
So Europe signed the contract too late, instead of the UK?
“I will not pass judgment on this. But I can only tell you the facts and the facts are that we basically signed an agreement with the UK three months before we did have it with Europe. Now, part of this can be easily explained. When we entered the agreement with Oxford, they had already been working with the UK government on this. So they had a head start. We were able to quite quickly take the UK supply chain and improve it. We had to modify the formula in the process, because Oxford gave us a process that needed to be modified to enable manufacturing at scale. Just think about, we've done all of this in months. Usually, it takes years. We got a manufacturing process that Oxford gave us, which was producing a good vaccine, but not at an industrial scale. It was just able to produce quantities for clinical trials. So then we had to modify the process to turn it into a process that could manufacture billions of doses. At a cost that is reasonable and at a speed that is reasonable".
"We had to change all of these. Then we had to do what we call technology transfer. So we go to each partner and we train them on the process. We train them on how to manufacture. And then, you know, some people are new to this process. It's like they learn the process. They don't know how to make the vaccine and they're not as efficient as others".
"So you may have lower productivity. That's why we have a productivity going from one to three. And so, unfortunately, it's really bad luck. Actually, there's nothing mysterious about it. But look, the sites that have the lowest productivity in the network are the sites that are supplying Europe. And quite honestly, I mean, we're not doing it on purpose. I'm European, I have Europe at heart. Our chairman is Swedish, is European. Our CFO is European. Many people in the management are European. So we want to treat Europe as best we can. You know, we do this at no profit, remember? We didn't go into this to try and make money or whatever. We would like to treat Europe as good as possible. I actually do believe we treated Europe fairly".
"Now, let me give you another number. Our total capacity globally now is about 100 million doses a month. From February onwards we are able to make 100 million doses a month, that's not small. Most vaccines have 100 million doses a year, that already takes us on a 1,2 billion pace per year. We are going to keep growing. Of course, we are ramping up production and Europe is getting 17 percent of this global production in February for a population that is 5 percent of the world population. Now, from the beginning we took very seriously the approach that Europe took, which we thought was fair and we all took. In fact, the US didn't say that Europe said that. Europe said the vaccine is common good and everybody needs to get access at the same time globally. That's what we are doing. Europe is getting 17 percent of our global supply for a month for 5 percent of the world population. The problem is: 100 million doses is a lot, but we have 7,5 billion people in the world".
"We are in the ramp-up phase and basically it will improve, but it takes time. Having said all of this, I'm not looking for excuses, honestly. We take accountability. We want to do better and we're working day and night. Our people in manufacturing, we have hundreds of people, thousands of people now. Many of them didn't take any Christmas vacation. I'm not asking you feel sorry for us but you know, we're doing our very best. But it's a very complicated process and a big scale”.
After the explanation you just gave at the same time it is striking the aggressive way which the EU has responded, even threatening to impose a new control on exports of activity out of Europe. Some are suggesting that you're selling your product to some other countries.
“The suggestion we sell to other countries to make more money is not right because we make no profit everywhere. That's the approach we took and we agreed on that. That’s the agreement we have with Oxford University. It's actually even written in a contract we have with Oxford University: that we will be at no profit. We have slightly different prices from one geographic to the other because the cost of goods may be different. We have a supply chain in Brazil, we have another one in Latin America, another one in South Asia. We have one in Japan. Of course, you know, local costs are different. So you've got slight variations, but more or less, it's about three to four dollars, more or less everywhere. It makes no difference. Zero difference. I understand we all want to be vaccinated. I think the populations of Europe, like everywhere else in the world, have been under so much stress with this pandemic for so long now, for a year or so, that people are tired. And I think the people who didn't want to be vaccinated maybe six months ago are now saying: "I want to be vaccinated". You have a lot of people who want to be vaccinated".
"So, governments are under pressure. Everybody is getting kind of a bit, you know, aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe. We're certainly not taking vaccines away from the Europeans to sell it somewhere else at the profit. It would not make sense, honestly, if you think about it: we engaged in this process a year ago and we're going to make zero profit. It would not make sense for us to then say "we're going to make a profit somewhere else and destroy the whole spirit of the agreement". First of all, we would be in breach of the agreement we have with Oxford. Secondly, we've done it because we want to do it for the good of humankind".
You said that the UK signed the AZ vaccine contract three months before EU, so you had more time to tweak and fix the potential disruptions of the supply. Why then did you commit to similar contracts with the EU, if you knew that in a very short time there could be problems like the one the EU supply chain is experiencing right now?
"First of all, we have different plants and they have different yields and different productivity. One of the plans with the highest yield is in the UK because it started earlier. It also had its own issues, but we solved all, it has a good productivity, but it's the UK plant because it started earlier. Anyway, we didn't commit with the EU, by the way. It's not a commitment we have to Europe: it’s a best effort, we said we are going to make our best effort. The reason why we said that is because Europe at the time wanted to be supplied more or less at the same time as the UK, even though the contract was signed three months later. So we said, “ok, we're going to do our best, we’re going to try, but we cannot commit contractually because we are three months behind UK”. We knew it was a super stretch goal and we know it's a big issue, this pandemic. But our contract is not a contractual commitment. It's a best effort. Basically we said we're going to try our best, but we can't guarantee we're going to succeed. In fact, getting there, we are a little bit delayed”.
So is this the contract that the EU signed?
“Yes, certainly. Now we have a vaccine and everybody thinks it's easy. But in April last year, everybody was saying “it's impossible to do a vaccine by the end of the 2020”, or “you're going too fast” or “you're cutting corners”, “you can't do it”, et cetera. Now everybody is saying “you’re too slow”, while before we were “too fast”. At that time, when we talked about those things, first of all we didn't know whether we would have a vaccine or not. We didn't know what the yield would be. When you develop a vaccine, usually you do that over five, six years. We did this in a few months, so we thought, you know, if we are successful, we can get through this yield. Unfortunately, some manufacturing sites got to the yield and others didn’t. We knew that it was going to be very challenging. But if we had not stretched the process like this, maybe we would not even be able to produce vaccines now”.
Italy is one of the countries that have explicitly threatened legal action against AstraZeneca. However, from what you have been saying, there is no feasible basis for a potential legal action against AstraZeneca.
“I don't want to give judgment on anything that has been said. I can only tell you what's in their contract. And the contract is very clear. Our commitment is, I am quoting, “our best effort”. There are a lot of emotions running in this process right now, and I can understand it: people want vaccine. I want the vaccine too, I want it today. But, at the end of the day, it's a complicated process. We are getting there, in two or three months we will be at scale. We have a 17-million-dose production per month right now, it is actually not small at all. But of course, it’s less than people want and understandably so”.
Is there any chance that the contracts could be reconsidered in the sense that you may distribute the vaccines in some other way? For instance, would it be possible to take some of the vaccines destined for UK and move them to the EU or some other countries? Or is this such a fixed contract that you cannot change it?
“The UK agreement was reached in June, three months before the European one. As you could imagine, the UK government said the supply coming out of the UK supply chain would go to the UK first. Basically, that's how it is. In the EU agreement it is mentioned that the manufacturing sites in the UK were an option for Europe, but only later. But we're moving very quickly, the supply in the UK is very rapid. The government is vaccinating 2.5 million people a week, about 500,000 a day, our vaccine supply is growing quickly. As soon as we have reached a sufficient number of vaccinations in the UK, we will be able to use that site to help Europe as well. But the contract with the UK was signed first and the UK, of course, said “you supply us first”, and this is fair enough. This vaccine was developed with the UK government, Oxford and with us as well. As soon as we can, we'll help the EU. I mean, as a company we are half Swedish and half British. In fact, we're global, of course, but we are European as much as we are British".
Neville's Breakfast
Well-known member
- Thread starter
- #265
Yes, you are right, with some caveats. First, if Germany chooses to follow EU guidance, in accordance with the views of the EMA, that is up to them. We chose to continue to use our own regulators and were never obliged to deny approval of any medicine for domestic use, and never 'told' to do so by the EU. Never. We could have chosen to follow EU process if we wished but we were never obliged.
And there were no EU quotas on a vaccine that had not been approved. There were (since last summer) aspirations and commitments to disburse vaccines when they were available (links below). Rather different.
You point I assume is that if we were still in the EU we would have had to have gone along with the strategy in the link posted above. I disagree. We could have chosen to, or not. Same as with other medicines. I think the EU are being silly at the moment, if they start demanding vaccine be redirected from the UK to the EU. We have a contract. Anyway, time will tell....I see Gove is already gleefully telling the EU to sod off; not done a telly interview yet - probably waiting for his tumescence to subside
The EU position with AZ appears to be as follows "Today's contract is based on the Advanced Purchase Agreement approved on 14 August with AstraZeneca, which will be financed with the Emergency Support Instrument. The “Inclusive Vaccine Alliance” countries (Germany, France, Italy, the Netherlands) who started negotiations with AstraZeneca asked the Commission to take over through an agreement signed on behalf of all Member States." see https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1524 So there may be an agreement signed by all the EU states, but this clearly would be an agreement (among states who agree); nothing to stop a state not agreeing if they wish. Nothing there about all member states agreeing to not pursue their own agenda, either. And there is also nothing there to say that EU states have priority over non EU states who may create their own arrangements (or indeed EU states).
:
Harry, a couple of points. You say you disagree with the notion that had we still been in the EU we would have been over ruled and compelled to join the EU wide vaccine strategy. Here is a quote and link from Robert Peston;
‘But, the EU insisted that the Inclusive Vaccine Alliance could not formalise the deal.
The European Commission insisted it should take over the contract negotiations on behalf of the whole EU.’
https://www.itv.com/news/2021-01-26/covid-vaccine-what-is-the-dispute-between-the-eu-and-astrazeneca
Is there any good reason to disbelieve this unambiguous statement ?
Regarding quotas it is indeed the case that there are quotas based on population at least in the initial stages. It is not an unreasonable approach for an organization with 27 members. Had we been EU members this would also have applied to the UK.
‘ All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of their population’
https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2467
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GOM
living vicariously
The government didn't just gamble on AZ or the EU manufacturers, they also spread the bet so that if any came in we were in the queue.
Astrazeneca
The UK has ordered 100m doses of the Covid vaccine being produced by the University of Oxford and Astrazeneca vaccine.
Pfizer/Biontech
The government confirmed it has ordered 40m doses of the vaccine.
Novavax
The British government has ordered 60m doses of a vaccine being produced by US biotech firm Novavax.
Valneva
The UK can expect 60m doses of Valneva’s coronavirus vaccine if proven successful.
GSK/Sanofi
The government has ordered 60m doses of a vaccine being produced by Glaxosmithkline (GSK) and Sanofi.
Janssen
Belgium-based pharmaceutical company Janssen, The Johnson & Johnson subsidiary. The British government has ordered 30m doses of the potential vaccine
GOM
living vicariously
Can I refer you to Robert Peston's contribution that has been oft quoted throughout this thread and the section
'What is frustrating for AZ is that the extra talks with the European Commission led to no material changes to the contract, but wasted time on making arrangements to make the vaccine with partner sites. The yield at these partner sites has been lower than expected'. .
So yes it is the EU's fault
Fair enough. But ignoring an insisting commission is commonplace. If we wanted to go alone we could have done so. The French have no problems with this.
That said this Peston quote is at odds with what is on the EC web page (links posted previously). Maybe the 'insisting' is just someone 'over there' gobbing off? It wouldn't be the first time.
GOM
living vicariously
Well if they didn't 'insist' then everyone, Hungary apart, fell in line 'voluntarily' despite not initially wanting to.
- Jul 10, 2003
- 27,360
Yes, you are right to point this out of course. All these numbers are significant underestimates. The UK was doing negligible testing in the first few months, so the 100,000+ number of deaths 'within 28 days of a positive Covid test' is more like 120,000+. A significant number of early deaths were discounted when the 'within 28 days of a positive test' criteria was added.
It is why Excess deaths is always the best figure to compare across countries, rather than any Government defined criteria.
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- Jul 10, 2003
- 27,360
nicko31
Well-known member
Hang, are you suggesting we could have done it without Brexit? Damn, I thought for a minute we'd finally discovered a real life benefit.
gazingdown
Well-known member
- Feb 26, 2011
- 1,067
Care needs to be taken with regards source of what the baseline actually is - or should be: https://twitter.com/VictimOfMaths/status/1350131613414391809
Neville's Breakfast
Well-known member
- Thread starter
- #274
So you disagree with Robert Peston’s analysis ? Can I ask if that is based on anything other than wanting it to be different ?
- Jul 10, 2003
- 27,360
If he is claiming we weren't under the same jurisdiction as the other EU members when we went it alone then yes. It's definitely not the first and I would think it unlikely to be the last time he has been wrong.
Just the plain simple facts.
The decision comes from the UK’s independent Medicines and Healthcare products Regulatory Agency (MHRA). It’s long worked in tandem with the European Medicines Agency (EMA) deciding which drugs are safe for use.
When we were part of the EU, the EMA had areas of jurisdiction that meant only it could make decisions about certain types of medicine, including vaccines. National regulators like the MHRA couldn’t get involved.
When the UK left the EU on 31 January last year, we entered the “transition period”, which means the European regulations we adopted during our time in the trade bloc were still in effect until the end of 2020.
That includes the rule that says vaccines generally must be authorised by the EMA instead of national regulators.
But as a UK government press release from 23 November 2020 states: “if a suitable COVID-19 vaccine candidate, […] becomes available before the end of the transition period, EU legislation which we have implemented via Regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.”
So even if we were still a member of the EU, the UK regulator would have been able to take this decision on its own because EU law already allows it. Incidentally, that legislation took effect in the UK in 2012, long before Brexit was on the cards.
Sorry
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dsr-burnley
Well-known member
- Aug 15, 2014
- 2,417
They were doing negligible testing of the not-too-badly-ill, but they were testing thoroughly in hospitals and infected care homes. I doubt the figure is too far out, especially when you factor in the "not really caused by covid" deaths of those who were already terminally ill. I'm sure the 40k early deaths weren't understated by a factor of 50%.
Neville's Breakfast
Well-known member
- Thread starter
- #277
If he is claiming we weren't under the same jurisdiction as the other EU members when we went it alone then yes. It's definitely not the first and I would think it unlikely to be the last time he has been wrong.
Just the facts.
Sorry
Today’s decision comes from the UK’s independent Medicines and Healthcare products Regulatory Agency (MHRA). It’s long worked in tandem with the European Medicines Agency (EMA) deciding which drugs are safe for use.
When we were part of the EU, the EMA had areas of jurisdiction that meant only it could make decisions about certain types of medicine, including vaccines. National regulators like the MHRA couldn’t get involved.
When the UK left the EU on 31 January this year, we entered the “transition period”, which means the European regulations we adopted during our time in the trade bloc are still in effect until the end of 2020.
That includes the rule that says vaccines generally must be authorised by the EMA instead of national regulators.
But as a UK government press release from 23 November 2020 states: “if a suitable COVID-19 vaccine candidate, […] becomes available before the end of the transition period, EU legislation which we have implemented via Regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.”
So even if we were still a member of the EU, the UK regulator would have been able to take this decision on its own because EU law already allows it. Incidentally, that legislation took effect in the UK in 2012, long before Brexit was on the cards.
https://www.channel4.com/news/factcheck/factcheck-brexit-did-not-speed-up-uk-vaccine-authorisation
I was talking about the EU not allowing the Inclusive Vaccine Alliance to formalize their deal with AZ. See post 257. Peston has asserted it as a ‘plain, simple fact.’ Do you know otherwise ?
Uncle C
Well-known member
That's good then. They can lower their demands.
Butch Willykins
Well-known member
The fact we were in the transition period (AKA Brexit) absolutely contributed to the UK decision to go it alone.
It's in black and white in here in a letter to the EU sent back in July.
https://assets.publishing.service.g.../Letter_from_Tim_Barrow_to_Ilze_Juhansone.pdf
Saying Brexit has nothing to do with our vaccine strategy is nonsense.
It's in black and white in here in a letter to the EU sent back in July.
https://assets.publishing.service.g.../Letter_from_Tim_Barrow_to_Ilze_Juhansone.pdf
Saying Brexit has nothing to do with our vaccine strategy is nonsense.
- Jul 10, 2003
- 27,360
Sorry, you quoted this
so I assumed this was what you were referring to.
*edit* I've looked at post 257 and that post is nothing to do with it ?
The very simple fact is that Brexit (or whether the UK was in or out of the EU) had absolutely no effect on the speed at which the UK could approve or order the vaccine, and yet this falsehood is repeated constantly
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