The biotech company Moderna has submitted an application to Swissmedic, the Swiss Agency for Therapeutic Products, for the authorisation of its vaccine candidate mRNA-1273. This is the third authorisation procedure initiated in Switzerland for a vaccine against the novel coronavirus.
Another COVID-19 vaccine under rolling review
The rolling submission procedure for mRNA-1273 is based on the initially submitted data packages on the preclinical situation and quality, as well as on preliminary clinical data. In a rolling review, the data can be evaluated as soon as they become available. The companies can then submit the latest data continuously without having to wait for the conclusive results from all studies.
Swissmedic can thus obtain an initial picture of the benefit-risk profile of the vaccine candidates before the authorisation studies are completed (Phase III studies). This accelerates the review process while at the same time preserving the same level of careful checking of all requirements relating to safety, efficacy and quality.
Swissmedic is already reviewing authorisation applications for COVID-19 vaccines from the companies AstraZeneca (vaccine "AZD1222") and Pfizer/BioNTech (vaccine BNT162b2).
In its scientific evaluation, Swissmedic is working closely with foreign partner authorities. Despite the high level of urgency, Swissmedic is still reviewing the scientific data in accordance with the usual internationally established standards. Drug safety is paramount.