Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)

Confirmation underscores Moderna’s commitment to make its vaccine available in Canada

CAMBRIDGE, MA, USA I October 13, 2020 I 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.

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.

“We are pleased with the interactions with the Canadian regulatory authorities and we appreciate their guidance and confidence in Moderna to pursue a rolling submission in Canada for our COVID-19 vaccine candidate, mRNA-1273,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies around the world and we will continue working closely with Health Canada.”

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 titers were 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 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 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. The clinicaltrials.gov identifier is NCT04470427. For more information about the Phase 3 COVE study, click here.

About Moderna’s Prophylactic Vaccines Modality

Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. Across Moderna’s pipeline, more than 30,000 healthy volunteers and patients have been enrolled in Moderna’s clinical studies, including the Phase 3 study of mRNA-1273. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.

Moderna currently has seven development candidates in its prophylactic vaccines modality, including:

Vaccines against respiratory infections

  • RSV vaccine for young children (mRNA-1345)
  • Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
  • COVID-19 vaccine (mRNA-1273)
  • Influenza H7N9 vaccine (mRNA-1851)

Vaccines against infections transmitted from mother to baby

  • Cytomegalovirus (CMV) vaccine (mRNA-1647)
  • Zika vaccine (mRNA-1893 with BARDA)

Vaccines against highly prevalent viral infections

  • Epstein-Barr virus (EBV) vaccine (mRNA-1189)

To date, Moderna has demonstrated positive Phase 1 data readouts for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV, Zika and COVID-19). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.

About Moderna

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 five years. To learn more, visit www.modernatx.com.

SOURCE: Moderna Therapeutics

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