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For the first time, an application for registration of a coronavirus vaccine has been submitted in Switzerland. The pharmaceutical authority Swissmedic announced on Tuesday that the scientific evaluation of the “Covid-19 Astra Zeneca Vaccine” had begun.
Astra Zeneca submitted the application for approval in early October 2020. They developed the vaccine in collaboration with the University of Oxford.
Scientific evaluation of the vaccine takes place in the “continuous submission” process. This would allow pharmaceutical companies to submit applications for Covid-19 drugs before application development and documentation is completed.
In this way, the approval decision can be expedited.
The drug approval decision could be sped up in this way, as Swissmedic had already evaluated the first scientific evaluations of laboratory studies (non-clinical data) while ongoing clinical studies continued. Study results available in the coming weeks and months should be sent to Swissmedic for scientific evaluation as soon as they are available.
A decision on authorization can only be made when all the data necessary to prove the safety, quality and efficacy of a vaccine are available, according to the Swissmedic notification. The documents would have to show how safely and effectively the vaccine protects people from the Sars-CoV-2 coronavirus. (SDA)
