On Oct. 13, 2020, Moderna announced initiation of a rolling submission to Health Canada for mRNA-1273, the Company’s vaccine candidate against COVID-19. This initiation followed 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 healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.

The rolling submission was accepted under the Canadian Minister of Health’s Interim Order, which permits companies to submit safety and efficacy data and information as they become available. This rolling review process allowed Health Canada to begin its assessment using the information submitted by the applicant and accept new evidence as it becomes available until the application is deemed complete. This process can reduce time to authorization for these important new drugs while maintaining appropriate standards of safety, efficacy, and quality. Health Canada will not make a decision to authorize any vaccine being considered under rolling review until it has received all necessary evidence to support its safety and efficacy. Following the authorization of any vaccine submission, Health Canada published the evidence used in making its decision for transparency.

On September 22, the Canadian Government increased its confirmed order commitment to 20 million doses of mRNA-1273. Moderna remains on track to be able to deliver up to 56 million doses of its COVID-19 vaccine to help protect Canadians beginning in 2021. The Canadian vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services.

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. In the 18-55 age group, neutralizing antibody titerswere observed in 100% of evaluated participants and at the 100 µg dose level selected for Phase 3, 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 the56-70 and 71+ age groups. In addition, vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses in all age groups.

mRNA-1273 was 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. As of Friday, October 9, the Phase 3 COVE study has enrolled approximately 28,618 participants with 22,194 having received their second vaccination.