BRIEF—Standard marketing authorizations for Comirnaty and Spikevax COVID-19 vaccines backed

The European Medicines Agency’s (EMA) human medicines committee (CHMP) today recommended converting the conditional marketing authorizations of the COVID-19 vaccines Comirnaty (from BioNTech and Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorizations.

As a result, these vaccines no longer need to be renewed annually. All other obligations for the companies remain in place.

Both vaccines were granted a conditional marketing authorization at the time of their approval.

This imposed obligations on the companies to submit results from the ongoing clinical trials and to provide additional data on the pharmaceutical quality of the vaccine in light of the planned manufacturing scale up.