28 January 2021

la Repubblica: “Pascal Soriot: There are a lot of emotions on vaccines in EU. But it’s complicated”

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.

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.

Antonello Guerrera, Stefanie Bolzen, Rafa de Miguel

The latest vaccination-related scandal in Europe involves AstraZeneca delaying deliveries of the Oxford vaccine to Europe, even though they are supplying the UK just fine. Difficult to judge the situation without access to the actual contract, but some of these explanations from AstraZeneca’s CEO don’t sound quite genuine. When he started invoking ‘bad luck’ in the interview, I started loosing faith is his sincerity.

He keeps coming back to the fact that the UK agreement was reached in June, three months before the agreement with the EU, thus justifying that the UK sites had time to scale up production and solve supply chain issues. That still leaves four to five months to fix these issues on the EU manufacturing sites – was that not enough time, considering the company should be able to capitalize on the experience setting up production in the UK? This also doesn’t quite explain why they could not deliver some doses produced in the UK to the EU market.

As for the “best effort” excuse (never mind this is something Boris Johnson would say about his government’s efforts to contain the pandemic), an analysis of a similar purchasing agreement made public suggests that this clause does not absolve AstraZeneca if they choose to divert supplies to another customer, the UK in this case. In case of manufacturing delays, the company should also inform the commission as soon as reasonably possible, explain the reasons for such delay and submit a revised schedule, something that AstraZeneca apparently did at the last possible moment. And now, when the EU is demanding better explanations and faster deliveries, the company is hiding behind confidentiality clauses, refusing to make the agreement text public. This alone is enough to be suspicious of their statements.

Only 1418 (12·1%) of those assessed for efficacy were older than 55 years (none of whom were in the LD/SD cohort), meaning that from the interim analysis of these trials, we cannot yet infer efficacy in older adults, who are the group at greatest risk of severe COVID-19 outcomes.

Maria Deloria Knoll & Chizoba Wonodi

Later in the interview, when the journalists start inquiring about vaccine efficiency among the elderly, Pascal Soriot evades a straightforward answer – and, sure enough, the company failed to rigorously test the vaccine over the age of 65, as reported multiple times. Consequently, German authorities have recommended in a draft statement that the Oxford/AstraZeneca vaccine against Covid-19 should not be used for people aged over 65 – some may like to see this as retaliation for the shipment scandal, but the trial data is simply not sufficient. Under these circumstances, administering the vaccine over the age of 65 would be equivalent to giving them a placebo…

Despite inconclusive trial results, the UK approved the vaccine and distributed it full speed ahead. Moreover, they allowed stretching the time between doses to up to 12 weeks, another decision not supported by available data. Curiously, AstraZeneca’s CEO has endorsed the change in this interview, raising, to me at least, even more questions about the integrity and reliability of the company. I’m sure this will not be the last time we hear about this issue…

Update: the day after I wrote this article, the European Commission published the redacted contract with AstraZeneca. The opinions I read on Twitter tend to side with the company, but from what I understand from the available text, the stipulations regarding manufacturing sites clearly include the United Kingdom:

EU Astra Zeneca vaccine agreement excerpt

That same day, the EMA has recommended use of the AstraZeneca vaccine in Europe, again with the remark that efficacy above the age of 65 cannot be assessed based on available data. I am curios to see if and when the US FDA will approve this vaccine based on their incomplete trials. I guess you can’t expect any better if you contract a company with little expertise on vaccines

Post a Comment