How good is Peter England's quality
"An emergency approval for vaccines for the entire EU is not legally envisaged for good reasons"
Berlin - Great Britain was the first country to issue temporary emergency approval for the COVID-19 vaccine from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer on December 2nd. 40 million doses of vaccine will now be gradually sent to England. Britain could go this route because Brexit took place, said British Health Minister Matt Hancock.
In an interview with the EPP Christian Democrats in the European Parliament, Peter Liese, among other things, explains why he considers this false statement to be “particularly spicy” German Medical Journal.
5 questions for Peter Liese, pediatrician and Health policy spokesman for the EPP Christian Democrats in the European Parliament
DÄ: Mr Liese, you consider the emergency approval issued by the British regulatory authority for the corona vaccine from Biontech and Pfizer in Great Britain to be problematic. Why?
Peter Liese: Vaccination is all about giving healthy patients a vaccine. This is not actually what the emergency approval is intended for.
The emergency approval is intended for cases where you have a life-threateningly ill patient whom you can only help with a drug that has not yet been approved.
Therefore, firstly, there is no liability for the manufacturer and, secondly, there are reduced requirements for the amount and quality of data that is presented.
I think we need a serious process and Biontech explained to me that the requirements of the European Medicines Agency (EMA) are a bit higher. I also think the decision in Great Britain is politically motivated to divert attention from mistakes in Brexit and in the fight against pandemics.
DÄ: England's decision formally has nothing to do with Brexit. The head of the British approval authority made it clear that Great Britain will comply with EU law until the end of this year and that this approval has also been granted under EU law. Do you now think it is possible that other EU Member States will follow the example of Great Britain?
Read: Unfortunately, Hungary is also considering going through emergency approval for the Russian vaccine Sputnik V. However, I consider that to be even more problematic because very little data is known about the Russian vaccine. I have no knowledge that other Member States are following the path and, with only two weeks to go, I believe that in practice it would no longer be possible.
DÄ: Couldn't the EU as a whole carry out an emergency approval for the vaccines?
Read: An emergency approval for vaccines for the whole of the EU is not legally provided for for good reasons. The possibility of national exemptions is actually about when a serious outbreak takes place in only one member state and therefore a regulated EU procedure cannot be pursued to the same extent.
Germany and many other member states have granted emergency approval for the drug Remdesivir. I don't think it's wise to work with lower standards. The two or three weeks that the extensive examination at the EMA takes should be worth additional security for us.
DÄ: When do you expect the first COVID-19 vaccine to be approved in the EU?
Read: The EMA has announced that the responsible committee will hold a special meeting on December 29th. If everything goes well, I can imagine that the date will be brought forward again and that we will receive the EMA's recommendation and approval from the European Commission before Christmas. However, if problems or questions arise, it may take longer. But then this is also necessary in terms of additional security.
DÄ: The vaccine has gone through a "conditional approval process". What does that mean?
Read: A conditional admission fulfills the requirements of a regular admission. This means that the manufacturer is liable for any damage and that data is carefully checked. However, firstly, as with any approval, there are possible restrictions, for example for children or certain risk groups, if it is not sufficiently clear whether they tolerate the vaccine well and secondly, the requirement to provide additional data. The conditional admission is only valid for one year. © ER / aerzteblatt.de
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