Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)
Excerpt from the Press Release:
CAMBRIDGE, Mass.–(BUSINESS WIRE)–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 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 will publish the evidence used in making its decision for transparency.
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