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28 Jan, 4 tweets, 2 min read
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?
If EMA approves AZ only for people below 65, presumably a lower delivery schedule of AZ in Q1 isn't as big of a problem because almost all EU countries are nowhere near stage of vaccinating healthy under-65s.

Would the EU continue the battle on principle of honouring contracts?

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More from @DaveKeating

Dave Keating Profile picture
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
Dave Keating Profile picture
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
Dave Keating Profile picture
28 Jan
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%."
Read 19 tweets
Dave Keating Profile picture
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
Dave Keating Profile picture
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
Dave Keating Profile picture
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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