On Nov. 13, 2020, Moderna announced that Swissmedic had started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19.

This announcement followed positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.

Moderna had initiated the rolling submission of mRNA-1273 data in consideration of a potential authorization for use of the vaccine candidate in Switzerland by Swissmedic, provided it meets Swissmedic’s rigorous standards of safety, effectiveness, and quality standards. This rolling review process allowed Swissmedic to review data from ongoing clinical trials as soon as it is available. This process can reduce time to authorization while maintaining usual high standards of safety, efficacy, and quality.