Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, 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.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past six years.