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Moderna Says Swissmedic Has Begun Rolling Review Of Co.'s mRNA-1273 COVID-19 Vaccine Candidate

Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22 Rolling review accepted based on preclinical, CMC, and clinical data available to date Moderna, Inc., (NASDAQ:MRNA) a biotechnology

· 11/13/2020 07:20

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

Rolling review accepted based on preclinical, CMC, and clinical data available to date

Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that Swissmedic has started a rolling review of mRNA-1273, the Company's vaccine candidate against COVID-19. This announcement 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+) published in the New England Journal of Medicine.

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 Swissmedic's rigorous 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 while maintaining usual high standards of safety, efficacy, and quality.

"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. For more information about the COVE study, click here.