February 28, 2021

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For the EU, the main process is not the result. About vaccines, bureaucracy and the willingness to take (in) risks

One of the moving topics across the EU is the vaccine against covid. EU companies face criticism that negotiations over the purchase of vaccines have benefited from small and delayed delays. Alexander Vondra (ODS), Stanislav Pollock (mayors and independents) and Irina Storova, head of the State Agency for Drug Control, discussed how justified this criticism is and how such approval for vaccines actually takes place.

Is the criticism that the European Union and the European Medicines Agency (EMA) accept vaccines too slowly being justified?

Wondira: I supported the joint order and the purchase of vaccines, but at the same time it shows how weak and inefficient the EU is in this. There are many reasons for this tragedy that we are lagging behind the United States, Great Britain, Israel, but also Arab countries like Bahrain and the United Arab Emirates. There are about five of them. The union put in far less money than the Americans. We are nowhere near the $ 18 billion that Donald Trump invested in Operation Warp as part of its momentum. Not surprisingly, Americans have a presence. Second, there is no option to take risks. Security first. This became clear in the conflict with Great Britain when Boris Johnson and the British authorities used the vaccine without putting it all together. Because they are in danger. Third, in this regard, there is the issue of legal liability. Israel, the United States and the United Kingdom have in fact accepted legal responsibility for possible side effects, which the Union has rejected. Fourth, it played at a very low price. But then there is the preference for those who pay more, and we should not be surprised. The last factor is, after all, the usual European politics. When it appeared that Astrogeneka was coming soon and that she would be ordered a large quantity, by being a British vaccine, all the French, from Macron to the EMA science component, began to cruelly call Sanobi to order. No one at the time was interested to see if Sanofi was far away so they could offer it this year. We all know by now that this will not be offered until the end of this year. In other words, weakness, reluctance to take risks, flexibility, politician, simply all the worst parameters here have actually caused a complete failure of the European Commission.

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Pollock: Many of the comments made by my colleague are at least controversial, and some are really reasonable. It was a big challenge, not implementing everything, I accept it, but I see it here as a fundamental problem that even the manufacturers were tactical, it is only now that it is known. AstraZeneca did not apply to register until mid-January, having long been registered in the UK. If the manufacturer has not applied for registration, of course the EMA registration system cannot be run and there is not even the possibility of publishing a decision. Consumer confidence, of course, and those who are considered to have the vaccine in the body later, I think this is very important, even if the process is standard and of course as soon as possible. Note the circumstances under which those orders were executed.

Do you see any problem on the part of the European Commission?

Pollock: In my opinion those issues arose at a time when this was becoming a fundamental principle. The head of the European Commission must sign all of those agreements, and it has not moved as a secondary to the department. That should be a high level priority. Now comes the delay. I got it yesterday (I.e. February 8 – Editor’s note) Information that the European Union has signed two more agreements with Pfizer. That’s right, but of course it could have been a little earlier. Vaccine registration was expected to take place early in the first quarter. We already have three vaccines in the first quarter that have been approved by the EMA, which is a big step because it was expected to be delayed by at least a few months. I hope we will say it’s reluctant at the end of this year, but it’s not as tragic as Sana Vondra says.

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Storova: I would definitely like to deny that something has been a favorite for EMA for a long time. I have never experienced such outspoken words. Being in control and doing certain actions overnight is so crazy. The teams at EMA only worked on holidays and weekends. You know very well that the first vaccine was approved just before Christmas Day and we checked the documents before Christmas Day. So I dare say no one is late. Rather, realize the mood in the public, there was skepticism as to why vaccines were approved so quickly.

You can read the whole salon Ecoprime. Or in the printed edition of Echo Weekly Magazine. You can subscribe here.

Photo: Weekly Echo