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After the US pharmaceutical company Moderna, the German company Biontech and the US pharmaceutical giant Pfizer have now applied to the European Medicines Agency (EMA) for approval of their coronavirus vaccine in the EU. The conditional marketing authorization application was submitted yesterday, Biontech and Pfizer announced today.
The EMA must now review the applications. It is not clear how long this will take. If the EMA recommends a conditional approval, the vaccine could still be used in December, Biontech announced. The final decision will be made by the EU Commission, which usually follows the EMA recommendation.
Rapid delivery possible
Biontech had announced that it would be able to start delivering the first vaccines immediately after approval. Biontech/Pfizer and Moderna have also submitted applications to the US Food and Drug Administration (FDA) for emergency approval.
Biontech/Pfizer’s vaccine is comparatively similar to Moderna in its mode of action and also in its efficacy. Both vaccines are already undergoing a rolling-review process at the EMA, which should accelerate the approval process. Manufacturers can submit individual parts of the quality, safety and efficacy of a preparation even before the complete application for approval. Below are the most important answers regarding the approval process.
hp, Source: ORF.at/agencies. picture: pixabay.com
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