Confirmation underscores Moderna’s commitment to make its vaccine available in Canada
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 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 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 has been 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 allows Health Canada to begin its assessment using the information submitted by the applicant and accept