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Fourth coronavirus vaccine being reviewed for marketing authorisation – authorisation requirements are very strict


The European Medicines Agency (EMA) has started the rolling review procedure on a fourth coronavirus vaccine candidate. The quality, safety and effectiveness of the vaccine are assessed with the same criteria as in the normal marketing authorisation process.

Marketing authorisation is granted for vaccines with sufficiently proven efficacy and safety and a positive relationship between efficacy and safety. The vaccine must have undergone at least one extensive phase 3 trial involving several thousands of people.

In terms of safety, an adequate number of people need to be vaccinated and an adequate period of monitoring is required to ensure rare or delayed adverse reactions are detected. It is also necessary for persons other than working age adults with good general health to have taken part in the trials. 


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