Dödligt virus från Kina orsakar panik (SARS-CoV-2, COVID-19)

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. ... 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. ... 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.
...
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. ... 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.”

"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”.
...
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".
...
"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".
...
"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. ... The problem is: 100 million doses is a lot, but we have 7,5 billion people in the world".
...
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” ... 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”.
...
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. ... 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.