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While other countries have already started their vaccination programs, the European Medicines Agency (EMA) seems to be taking its time. There are reasons for this.
By Helga Schmidt, ARD-Studio Brussels
The pressure on the EU authorities is increasing. The UK has already started mass vaccination, also the US The question is also asked in Brussels.
The EU Commission is said to have asked the European Medicines Agency (EMA) responsible in Amsterdam to approve the vaccine more quickly. Reuters news agency reports and cites internal sources.
Peter Liese MEP is in close contact with the team of experts in Amsterdam, defends the European approval procedure: “In the European Union, more data must be made available. Biontech has confirmed to me that the depth and granularity of the data that they have to provide to the EMA is greater than the data they have provided to the UK. “
Mainz-based Biontech and its US partner Pfizer submitted a conditional marketing authorization two weeks ago. The more data they have to provide Amsterdam, it is mainly test results on side effects – the EU authority is interested in more data than its colleagues in Britain.
“Due to early approval in the US and Britain, there is, of course, the risk of side effects that one might have discovered after careful examination,” says Liese. “There are already the first restrictions in Britain, for example for people with allergies.”
Liese is a doctor and health expert from the CDU in the European Parliament. He believes that it is correct that the EMA not only relies on its own experts, but also has all the findings reviewed again by the experts from the member states: “The British authority is definitely a good authority,” Liese said. . “But they say yes, four eyes see more than two. And in this case it should be much more.”
On the German side, the EMA works closely with the Paul Ehrlich Institute in Langen. The exchange takes longer than if a decision were made centrally, for example, in London.
It’s about safety and a lot of money
Effort is not only necessary from Liese’s point of view. Other health experts from the Brussels Commission also argue that manufacturers’ data is being analyzed. After all, there is a lot of money at stake for pharmaceutical companies; compete with each other. For this reason alone, careful monitoring is necessary.
Still, there are indications in Brussels that the original approval date of December 29 could be moved a bit earlier. Subsequent market approval by the Commission could be granted in less than 24 hours, according to Brussels.
