Moderna has received Health Canada's approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.
This marks the introduction of the first mRNA RSV vaccine in Canada and the second approved product of Moderna in the country.
The approval by Health Canada is supported by the outcomes from the ConquerRSV Phase III study, which involved approximately 37,000 patients aged 60 and above across 22 countries.
The trial's primary analysis indicated an 83.7% efficacy in preventing RSV LRTD after a median follow-up of 3.7 months.
Moderna CEO Stéphane Bancel said: "Today's approval is an example of how our mRNA platform can help address significant public health challenges like RSV.
"As our second product approved by Health Canada, mRESVIA underscores our commitment to leveraging mRNA technology to protect vulnerable populations and contribute to a healthier future for Canadians."
mRESVIA is reportedly currently the only vaccine available in a distinct single-dose prefilled syringe format.
This is intended to streamline the vaccination process for healthcare professionals, potentially reducing the risk of errors and saving time. The expected availability of mRESVIA in Canada is in early 2025.
The company is also actively seeking marketing authorisations in various jurisdictions globally. Canada is the fourth to grant approval, following Europe, Qatar, and the US.
Canada’s National Advisory Committee on Immunization endorses RSV vaccination for those aged 75 and over and for individuals aged 60 years and above living in chronic care facilities and nursing homes.
Vaccination for community-dwelling individuals over 60 is advised to be a personal decision made after consulting with a healthcare provider.
The vaccine comprises an mRNA sequence that encodes the RSV F glycoprotein, which is essential for the virus' ability to infect host cells.
The drug also received US Food and Drug Administration approval in June this year and is anticipated to be available in the country in time for the 2024-25 respiratory virus season.
