Switzerland – CureVac Swiss AG submits application for authorisation of COVID-19 vaccine (CVnCoV) to Swissmedic

CureVac Swiss AG has submitted an application for the authorisation of its COVID-19 vaccine candidate CVnCoV to Swissmedic. This is the fifth authorisation procedure initiated in Switzerland for a vaccine against the SARS-CoV-2 virus.

With the rolling review procedure, Swissmedic evaluates the scientific data as soon as they become available and are submitted by the companies concerned. CureVac can forward documentation on its vaccine candidate on an ongoing basis without having to await the final results of the clinical trials.

Swissmedic is thus given an initial picture of the benefit-risk profile before the authorisation (Phase III) studies are completed. This procedure, which proved successful for the COVID-19 vaccines authorised to date, ensures that the requirements with regard to safety, efficacy and quality can be examined carefully and yet very swiftly. The duration of the rolling review will depend on the completeness of the data submitted by CureVac and the results of the clinical trials, and cannot therefore be predicted…