Therapy Areas: Vaccines
Moderna Starts Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)
13 October 2020 - - US-based biotechnology company Moderna, Inc., (NASDAQ: MRNA) has initiated a rolling submission to Health Canada for mRNA-1273, the company's vaccine candidate against COVID-19, the company said.

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 m doses of mRNA-1273.

Moderna remains on track to be able to deliver up to 56 m 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 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 US 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.

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.
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