The UK was able to say on Wednesday that it was the first country to give the green light for Pfizer and Biontech’s coronavina vaccine to be used in emergency use.
However, it is now facing criticism from the EU that the emergency approval has come so quickly.
In an opinion, the European Medicines Agency (EMA) states that the Agency’s longer authorization manufacturers are more appropriate. The EMA must approve the vaccine in the EU.
The UK approval came on Wednesday, just ten days after authorities began reviewing data from the major studies with the vaccine.
The EMA is currently processing an application for a conditional approval of the vaccine. However, it is not the same type of approval as in the UK.
A decision is expected here no later than 29 December, after which the European Commission must formally grant the conditional approval.
June Raine, director of the UK Medicines Agency, defends the decision.
– The way the MHRA (Drug Administration, ed.) Has worked corresponds to all international standards, says Raine.
A conditional approval is not an emergency approval, but rather a “real” approval. It can be given before there is long-term data on effects and possible side effects.
This can happen if the benefits of a quick launch outweigh the risks involved in not having quite as much long-term data as usual.
It must be extended once a year, and new data must be submitted on an ongoing basis on, among other things, the effect.
It usually takes ten years from the idea of a vaccine until it is approved. However, it has gone much faster during the corona crisis.
This is partly due to the fact that pharmaceutical companies around the world have invested huge sums in the development of vaccines.
At the same time, the authorities have the opportunity to give a faster approval than usual. Both because data from the pilot studies have been submitted on an ongoing basis, and because the authorities have allocated far more people to the approval process.
Source: jyllands-posten.dk
