Swissmedic will review the application in the rolling procedure. Pfizer can submit the latest data continuously without having to wait for the conclusive results from the clinical studies.
The vaccine "Comirnaty®" is currently authorised for people aged 16 and over. The application asks for the authorisation to be extended to include the age group of 12-15-year-olds.
The duration of the rolling review will depend on the completeness of the submitted data and the results of the clinical trials. Swissmedic will be able to reach a decision on authorisation after completion of the expert report. Last week, Pfizer/BioNTech also submitted corresponding applications to the EMA (European Medicines Agency) and the FDA (US Food and Drug Administration).
Swissmedic grants Novartis establishment licence for the filling and packaging the vaccine "Comirnaty®"
Companies that manufacture or distribute medicinal or transplant products in Switzerland require an establishment licence. Swissmedic grants these licences on the basis of a successful inspection. An establishment licence is evidence that the company possesses the resources and processes needed to ensure and constantly monitor the quality of its products. At the end of April, Swissmedic issued Novartis at its Stein (Canton Aargau) production facility with an establishment licence for filling and packaging the Comirnaty® vaccine on behalf of the authorisation holder.