EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines

EMA

16 September 2022 - The EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorisations. 

These no longer need to be renewed annually. All other obligations for the companies remain in place.

Read EMA press release

Michael Wonder

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Michael Wonder

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Outcome , Regulation , Vaccine , COVID-19