Rolling submission of mRNA 1273 initiated for COVID-19 with Health Canada.- Moderna

Moderna Inc announced the initiation of a rolling submission to Health Canada for mRNA 1273, the Company’s vaccine candidate against COVID-19. This initiation follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase I study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine. The Phase I 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. In the 18-55 age group, neutralizing antibody titers were observed in 100% of evaluated participants and at the 100 µg dose level selected for Phase III, the geometric mean titers were above those seen in convalescent sera. Similarly, mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the 56-70 and 71+ age groups. In addition, vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses in all age groups.mRNA-1273 is currently being studied in a Phase III randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 microgram dose level in the U.S. As of Friday, October 9, the Phase III COVE study has enrolled approximately 28,618 participants with 22,194 having received their second vaccination. See-- "Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults". Evan J. Anderson, M.D., Nadine G. Rouphael, M.D., , et al., for the mRNA-1273 Study Group-September 29, 2020 DOI: 10.1056/NEJMoa2028436.