Vaccine for children from 12 to 15 years
The "Comirnaty" vaccine has so far been approved for people aged 16 and over. An application from the federal government provides for the authorization to be extended to the age group of 12 to 15-year-olds. Swissmedic will examine the application in a rolling procedure.
The duration of the rolling assessment depends on the completeness of the data submitted and the results of the clinical trials. Swissmedic will be able to make a decision on approval once the assessment has been completed. Pfizer/BioNTech also submitted corresponding applications to the EMA (European Medicines Agency) and the FDA (US Food and Drug Administration) last week.
Swissmedic grants Novartis operating license to fill the Comirnaty vaccine
Companies that manufacture or supply medicinal products or transplant products in Switzerland require an establishment license. Swissmedic issues these licenses on the basis of a successful inspection, among other things. An establishment license proves that the company has the necessary resources and processes in place to ensure the quality of the products and to monitor them on an ongoing basis. At the end of April, Swissmedic granted Novartis an establishment license for the Stein production site (Canton of Aargau) for the filling and packaging of the "Comirnaty" vaccine on behalf of the marketing authorization holder.
Source: Swissmedic, Swiss Agency for Therapeutic Products
