Thread by @hhesterm

As there's a lot of "this is all EU politics" out there on AZ drug admission: some food for thought. I have deleted a lot of tweets on this. I will try to be brief, informative and neutral. (Thread)

At the origin are reports that some of the AZ vaccines in Germany are in storage. The problem of AZ take-up exists. Numbers are not as high as people believe. /2

Germany has received 1.5 million doses of AZ, 6.7 million doses of Pfizer/BioNTech. /3 impfdashboard.de

0.5 million of the AZ have been vaccinated. Germany does follow a 2 jab policy and creates storage for jab 2 to avoid delivery problems. Not sure to what extend that holds true for AZ as well. /4

AZ has been approved by EMA for everyone, the German StiKo however has decided it does not have enough data for over 65 year olds (that decision is now under review), so those will get Pfizer, younger ones AZ /5

It is that StiKo decision that has led to criticism in the UK - and it was accused of playing EU politics, along with French and Belgian regulators. /6

Criticism singles out EU regulators. That in itself is problematic. AZ has not been approved in the US by the FDA because the FDA saw problems with trial data. /7 thehill.com/policy/healthc…

Switzerland has not approved the AZ vaccine for the same reason. /8 bernerzeitung.ch/die-schweiz-pr…

Canada has approved AZ, but - similar to Germany - the advisory body on Immunization does not recommend it for over 65 year olds. /9 globalnews.ca/news/7670304/c…

The issue goes back to the sub-optimal phase 3 trials. Regulatory now have a problem: does the data suffice? And regulators clearly take different calls. There's a number of interesting questions here (and possibilities for criticism) /10

So, for example: To what extent can regulators weigh the risk of the disease? Should this be changed? As a rule or just for covid? - Some have suggested that availability of a vaccine be taken into account. Etc. etc. /11

Some have also suggested that the "data is now in". But is it? We have plenty of studies. But are those up to FDA standards? Fulfill applicable regulatory criteria? There's a difference between "my study is on the internet" and "the FDA thinks the data is conclusive" /12

Here too there are questions. What are the requirements for a study? Are we too strict? Lots of possible work to be done. /13

The line that is popular, however, pitting the UK against the EU simply does not hold up to scrutiny. It is - for this one debate - irrelevant. /14

So what about the following three items: a Handelsblatt article citing an unnamed coalition source, and statements by two French politicians, @CBeaune and @EmmanuelMacron - all three statements criticizing the AZ vaccine? /15

The first thing: none of them has anything to do with the regulators' decisions. But also: note how incoherent these are. The Handelsblatt source misinterpreted the data of the StiKo (later leaked). Data illiteracy (a common phenomenon). /16

The vast majority of statements by politicians (I can speak for Germany only, cannot watch all news all the time) - is in favor of AZ. And the pressure on the regulator is to approve - not to not approve. /17

And important final point (h/t @grippo77): none of this is to criticize the UK regulator. It is entirely normal that different regulators can come to different conclusions. And this, I think is one of the problems here. /18

Different regulators come to different conclusions quite often. That in and of itself should not be read as criticism. I lack the detailed comparative law knowledge to know what and how and where the FDA, the Canadians, the StiKo and the UK regulators diverge. /19

But please don't read my defense of US/Canadian/Swiss/German regulators as attacking UK ones. That is absolutely not what I am doing here. /20

I would ask you to consider for a second where we now are: two regulators take different judgment calls based on the data they have. Both decisions are reasonable. But you can no longer defend one regulator, because it is perceived as an attack on the other. /21

Well, I refuse to play ball. I think all of them acted reasonably and it would be interesting to see how, why and where exactly they diverge. I've seen lots of hatred on twitter and anger. But few people (code for none) trying to understand these differences. Bravo mankind! /22

That's it. I now have some real work to do on international law. Sorry for boring you until this point. But I have now been frustrated for days at the level of debate. And please don't anger tweet about the UK or the EU in response to this thread.

Clarification, even though a bit tiresome: when I said Germany follows a 2-jab policy what I meant is that it kept vaccine on storage for the second jab. Everyone does two jabs, of course.

OK. Curiously I have now been attacked for being self-serving, long-winded and not focusing on topics I am not writing about. I had people misreading tweets and misconstruing others to serve their individual hatreds. Way to go.

I apologize for not participating in the general search for a pretext why we should all hate each other.

Addendum: the situation with the US is complex in its own right, as I am not entirely sure which data AZ planned to use for its application and there was an independent problem in the US studies. nytimes.com/2020/12/08/bus…

But I should say: these studies and FDA law is incredibly complex. The fact that there are problems does NOT say anything bad about the drug, nor about AZ. These things take time and we operate in a highly compressed time frame.