Some information on the analysis undertaken by the PEI pei.de/SharedDocs/Dow…
Includes such great terms as pharmacoviligance risk assessment and observed v expected analysis, even though it's in German. And it explains the timing of the decision of the PEI.
(Just in case: PEI= Paul Ehrlich Institut, the German federal institute for vaccines, sort of the Robert Koch Institut for vaccines)
@Sarah_Montague perhaps of interest: the PEI FAQ on its decision

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More from @hhesterm

16 Mar
A quick hypo: assume a glass vial manufacturer has a production issue and a charge of 10.000 of its vials is contaminated. The vial is used for vaccines. The contamination leads to an increased frequency of heart attacks. How does the regulator find out?
Another hypo: assume one of the chemicals used in producing a vaccine is not up to the normal standard of the company. Despite using the adequate standard of diligence they do not detect it, because it wasn't detectable. How does the regulator find out?
The answer is: the regulator gets tons and tons of data on problems. From "I felt like I had to drink alcohol after taking the drug, which is why I had to drive drunk" (well, dubious) to "I could not sleep" to "X died, no idea why".
Read 6 tweets
15 Mar
An object lesson in how doing a bit of research, but not really research ends up misinforming rather than informing people. A thread
The information in the above thread has all the hallmarks of what one might think of as "good information". It has numbers (we love numbers). A source. Comparisons.
And yet it actually misinforms rather than informs. The lesson for students: you need context to interpret data.
The thread refers to data from adverse reaction reports. The EMA collects these in a website. But what the thread does not explain is what these reports mean. The EMA actually puts a disclaimer on its website. Here it is.
Read 7 tweets
12 Mar
The US has 10s of millions of doses of AZ vaccine in storage. It has not admitted the vaccine, but does not allow AZ to export. Now I do not engage in this debate, but I am interested in the meta-debate, the debate about the debate (short thread) nytimes.com/2021/03/11/us/…
I have not seen this NY Times story from yesterday in my timeline. I think it is safe to say that it has not caused anything near the outrage that was caused by Germany being slow administering AZ and having 1 million doses on storage. /2
So why the difference? I know some people will say “but the US was not talking AZ or the UK down”. Which only leads to more curiosity, because it means that we’ve also missed stories like this one. /3 theguardian.com/society/2020/o…
Read 7 tweets
8 Mar
A question on the institution of the monarchy (explainer in thread): what do people nowadays think is the legitimation of the monarchy? Are there surveys on it? (thread)
The Brexit debate has, again and again, waxed lyrical on democracy. The undemocratic setup of the UK Constitution rarely featured - if it did, it usually resulted in fierce attacks on the House of Lords. I have not seen any attacks on the Crown.
For someone who has not grown up in a monarchy that is remarkable. Title-wise, of course, the Queen is Queen by the Grace of God. But in time in which so many are agnostic or atheist I don't think a lot of people feel that justification to work.
Read 5 tweets
7 Mar
Quick question to @EmDunks : there have been negotiations on a global trade in services agreement since 2012. But those are not among all 164 WTO Members. So... is this different? (thread)
Here's the participants of the TISA negotiations in a handy map courtesy of @BMWi_Bund
Even though this group calls itself the Really Good Friends of Liberalization of Trade in Services (or RGF) they have not reached an outcome. (correction of the first tweet, btw: formal negotiations started in 2013)
Read 4 tweets
2 Mar
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
Read 28 tweets

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