Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19

Biotechnology company Moderna, Inc. a pioneer in messenger RNA (mRNA) therapeutics and vaccines that create the next generation of transformative medicines for patients, today announced that Swiss Medicine has begun a rolling review of the company's vaccine mRNA-1273 against COVID-19 candidates. This announcement follows positive results from the preclinical viral challenge mRNA-1273 study in adults (18-55 years) and older adults (56-70 years and 71+ years) and a positive interim analysis of the mRNA-1273 Phase 1 study, published in the New England Journal of Medicine.

Moderna has begun a rolling submission of mRNA-1273 data considering Swissmedic's compliance with Swissmedic's stringent safety, efficacy and quality standards for the potential use of this vaccine candidate in Switzerland. This rolling review process allows Swissmedic to review data from ongoing clinical trials as quickly as possible. This process reduces authorization time while maintaining the usual high safety, efficacy and quality standards.

Moderna CEO Stéphane Bancel said: "We are grateful for the collaboration with Swissmedic to date to address this ongoing public health emergency. "We are pleased with the recent encouraging Phase I interim analysis of mRNA-1273 in the elderly population, which we recently published with the National Institutes of Health. We look forward to the first review of our interim efficacy data hopefully from Phase 3 data."