Update from MEP @PeterLiese, health spokesman for the largest party in the EU Parliament (thread):

He maintains #AstraZeneca is treating people in EU as "2nd class citizens" and that doses have gone from the EU to the UK.

"They gave 3 different explanations in less than a week"
Carrot: He's says objections are with AZ behaviour, not vaccine's efficacy

"There's been a lot of talk about AZ being a bad vaccine - very strange fake news in German media. It's definitely not true"

"If someone offered me AZ, and it’s my turn, I wouldn’t hesitate for a minute"
“The AstraZeneca vaccine has not as good data as the vaccines from BioNTech/Pfizer and Moderna but still it is a good vaccine. In October, we would have been happy to have a vaccine that has an efficiency well above 50%."
Stick: "AZ gave 3⃣ different explanations in less than a week why there is a shortage of supply on the European continent and why they want to deliver only 31 million doses instead of 80 million that they committed to in the contract until the end of March."
1⃣ "1st explanation was different supply chains. This is wrong because in contract with the EU, two plants in the UK are mentioned for the supply on the continent and at least until a few days ago the final finishing of the vaccine [for UK] has been in a plant in Dessau, Germany"
"The final filling of the AstraZeneca vaccine, at least until a few days ago, among others has happened in Dessau, Germany and the product was shipped to the UK. How can #AstraZeneca argue there are 2 separate supply chains for the UK and EU? It’s nonsense," says Liese.
2⃣"2nd explanation was there's also reduced supply for the UK" (unclear if that's the case)

3⃣ "Now they say the UK has a better contract. To be honest, if a company treats European citizens as
second class, this has serious consequences for the long-term cooperation with EU"
"Investors will not like that everyone in the biggest market in the world is mad with a company." Liese says he's heard private equity backers are not happy with the company over this week's events.
"3 explanations in less than a week? Can you trust this company when it comes to the contract, delivery and reason for the shortage? My answer is no, when it comes to these issues. But you can trust them when it comes to efficacy."
"It’s clear, they can't deliver as planned. But they can't shorten the delivery to EU and continue delivery to the UK as if nothing has happened. I asked AZ, do you want to be a British company, or a world company:? A world company cannot ignore the biggest market in the world."
Liese says if UK plants need to be used to meet the EU's order, that is only fair.

"If they find another solution, great. But if the only solution is to have a reduction of the delivery to the UK, and that would bring more vaccine to the EU, that is only fair."
"Average people don’t trust the pharma industry. In the parliament I always have to defend that we cooperate and give money to them."

"The reputation of the pharma industry is already bad, if they behave like this it will be even worse."
Interestingly, Liese says EU has been hurt by using more-robust conditional approval process (takes longer) rather than emergency approvals as UK & US did.

But when EU made the decision, they didn't know:
-2nd wave would be so bad
-Pharma companies might give agreed doses away
"Emergency authorisation is less quality than conditional market authorisation. Pfizer had to give more detailed data to EMA on side effects than they gave to the British under emergency authorisation. But EA is a possibility under EU law, that's why UK could use it last year"
"It could be done by Germany, legally it’s possible, for #SputnikV for instance. But this means less data, no liability for the company if they make a mistake, and less people are looking at it. Would be only the Germans, not the Swedish and French and other experts."
"I asked the Commission in October if they’d consider emergency use authorisation, they presented good reasons why not. Also the member states could have done it but they didn’t."

"But I didn’t expect the second wave to be as bad as it is."
"I still think there are good reasons for not doing EA. It’s normally for a patient that is in hospital and can only be cured if you use a medicine that is not licensed but may be helpful. With a vaccination you vaccinate healthy people."
"With BioNTech/Pfizer, the longer conditional approval didn’t have the context that EU would get less vaccine. Because it was in the fridge and they started from day 1 after approval to deliver"

"But now we see that other companies are behaving worse, and that creates a problem"
To paraphrase: he believes EU had good reasons to avoid emergency authorisations so far. But if it means pharma companies are going to give away promised vaccines in the mean time when the more-robust conditional approval takes longer, should EU switch to emergency-approval now?

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More from @DaveKeating

29 Jan
BREAKING: #AstraZeneca has consented to allowing the European Commission to publish a redacted version of its contract with the EU.

Published here: ec.europa.eu/commission/pre…
Legal eagles, go to town.

Looking forward to your analysis.
Well, this isn't very helpful... Image
Read 5 tweets
28 Jan
A thread on conditional authorisation (used by EU) versus emergency use authorisation (used by UK & US) for vaccines - a topic that I think is going to be more explored in the coming days given the AstraZeneca news out of Germany today.

First off: what's the difference?
Each type of vaccine approval comes with pros and cons:

🐇Emergency is faster but it's risky - requires less data and makes govs liable instead of pharma if anything goes wrong.

🐢Conditional takes longer but is more robust and makes pharma accountable.
thebulletin.org/2020/11/is-eme…
The 27 national authorities decided EMA should use conditional approval back in October, at a time when the extent of the 2nd wave & new strains wasn't yet known.

The UK & US chose emergency approval - controversial in US at the time because it looked like Trump was rushing it.
Read 10 tweets
28 Jan
BREAKING: Germany's vaccine committee says there is not enough data to give a green light for #AstraZeneca vaccine to be used on patients over 65.

EMA approval at EU level still pending tomorrow...
I think all of the focus on one % figure in the German media reports about this over the past days obscured the larger point: Germany is not comfortable giving this shot to the only category of people who are receiving it right now.
Given this new development in Germany, I would guess that EU Medicines Agency approval for the #AstraZeneca vaccine tomorrow is now seriously in doubt.

If EMA doesn't approve, does it render the whole #VaccineWar thing suddenly moot?
Read 4 tweets
27 Jan
Barnstorming press conference from EU Health Commissioner @SKyriakidesEU, responding to #AstraZeneca suggestion UK gets vaccine priority because it signed deal earlier.

"In our contract it is not specified any country, or the UK, has priority because it signed earlier."
"Let me be crystal clear: the 27 EU member states are united AstraZeneca needs to deliver on its commitments in our agreement. We are in a pandemic."

"The view that the company is not obliged to deliver because we signed a best effort agreement is neither correct or acceptable."
"We reject the logic of first-come-first-served. That may work at the nieghbourhood butchers, but not in contracts," says the EU's health chief.

"There is no priority clause in the advance purchase agreement, and no hierarchy of the 4 production plants - 2 in EU and 2 in UK."
Read 5 tweets
26 Jan
The EU Commission says that it helped finance the development of the #AstraZeneca #COVID19, and in return it was supposed to get guaranteed access to 300m doses.

Now, the Commission suggests those doses appear to have been given to someone else.
The EU may prevent Pharma companies from exporting vaccines made in facilities in EU countries that have been promised to the EU.

Questions are also being asked why AZ didn't apply for EU authorisation until 12 January. EU approval expected Friday.
Commission President @vonderleyen told #Davos2021 this morning the pharma companies "must honour their obligations".

But what are those obligations? We don't know exactly because neither EU or UK are making these contracts public.
Read 5 tweets
26 Jan
Update from the European Commission: they are indeed considering export notifications for vaccines.

"This is not about blocking, this is about knowing what the companies will export,” says a spokesman.

But what if the EU doesn’t like the information that has been notified?
The spokesman will not elaborate at this time about whether the export notification could then result in an export restriction.

But based on what they’re saying (and also what national ministers are saying), that does seem to be the plan. Otherwise what’s the point of notifying?
For instance, President @vonderleyen’s address to #Davos2021 this morning:

“The EU and others helped with money. Large sums were invested to build research capacities and production facilities early...and now the companies must deliver.”
Read 4 tweets

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