Thursday, 05 October 2023 09:00 AM
Regulatory
mRNA-1345 is an investigational vaccine for the prevention of RSV in adults aged 60 years or older
TORONTO, ON / ACCESSWIRE / October 5, 2023 / Moderna Biopharma Canada Corp. today announced the filing of a New Drug Submission (NDS) to Health Canada for mRNA-1345, its investigational vaccine candidate for the prevention of RSV in adults aged 60 years or older. This is the first mRNA vaccine candidate for RSV filed in Canada.
RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions.1 Mortality is more common among the elderly hospitalized for RSV compared to other adults.1
"We've seen the impact that respiratory viruses like RSV can have on the health and wellbeing of Canadians. As we approach the height of respiratory virus season, we're pleased to now have a second vaccine candidate from our mRNA platform seeking regulatory approval in Canada," said Leslie Madden, Head of Regulatory Science, Moderna Canada. "Our mRNA platform is enabling us to tackle this pervasive public health burden with speed and clinical rigor and we look forward to supporting the Health Canada review of this important submission."
The regulatory submission is based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries, including Canada. The submission follows the company's filings for mRNA-1345 with regulators globally, including the European Medicines Agency (EMA), Swissmedic in Switzerland, the Therapeutic Goods Administration (TGA) in Australia, and the U.S. Food and Drug Administration (FDA).
About Moderna
Since its inception in 2010, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna has established relationships with government and commercial collaborators, which have allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. In Canada, Moderna has a 10-year strategic partnership with the Canadian government to enhance pandemic response capabilities. This includes building an advanced mRNA manufacturing facility for respiratory vaccines currently under construction in Quebec. Moderna is also committed to helping position Canada as a leader in mRNA research and development with partnerships across the country. To learn more, visit www.modernatx.com/en-CA
Moderna Contacts
Canada Media:
Sacha Kennedy
Director, Communications and Media
[email protected]
International Media:
Luke Mircea Willats
Senior Director, Corporate Communications
[email protected]
- Cong, B., Dighero, I., Zhang, T. et al. Understanding the age spectrum of respiratory syncytial virus associated hospitalisation and mortality burden based on statistical modelling methods: a systematic analysis. BMC Med 21, 224 (2023). https://doi.org/10.1186/s12916-023-02932-5.
SOURCE: Moderna Biopharma Canada Corp.