Swissmedic Begins Rolling Review of Moderna’s mRNA COVID-19 Vax

By Contract Pharma Staff | 11.13.20

Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22.

Moderna, Inc. announced that Swissmedic has started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19. This follows 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+).

Moderna has 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 standards of safety, effectiveness, and quality standards. This rolling review process allows Swissmedic to review data from ongoing clinical trials as soon as it is available. This process can reduce time to authorization.

“We appreciate the collaboration we have had to date with Swissmedic to address this ongoing public health emergency,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are pleased with the encouraging Phase 1 interim analysis of mRNA-1273 in the older adult population, which we recently published together with the NIH. We look forward to our expected first review of our interim efficacy data from our Phase 3 data.”

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S. On October 22, Moderna completed enrollment of the Phase 3 COVE study and on November 11, Moderna completed case accrual for the first interim analysis of the Phase 3 COVE study.