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First coronavirus vaccines being reviewed for marketing authorisation


Ensimmäiset koronavirusrokotteet myyntilupa-arvioinnissa

The European Medicines Agency (EMA) has started the rolling review procedure on two coronavirus vaccine candidates. A rolling review is a tool that can be used to speed up the marketing authorisation process of promising vaccines during a pandemic, for example.

The quality, safety and effectiveness of the vaccine are assessed with the same criteria as in the normal marketing authorisation process. A marketing authorisation may be granted if studies show that the benefits of the vaccine outweigh its risks.

In the accelerated review process, research data are evaluated as they become available. After assessing all available data, EMA will provide its conclusion regarding the use of the products in Europe.