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

EMA’s human medicines committee (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.

Both vaccines were granted a conditional marketing authorisation at the time of their authorisation1. 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.

These trials and additional studies, including observational studies, have provided reassuring data on key aspects such as how well the vaccines prevent severe COVID-19. In addition, the companies have provided all requested additional data on the pharmaceutical quality of the vaccines…