Moderna announced that Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older.
“This approval demonstrates how our mRNA platform can tackle significant public health challenges like RSV,” said Stéphane Bancel, CEO of Moderna. “As our second product approved by Health Canada, mRESVIA reflects our commitment to using mRNA technology to protect vulnerable groups and support a healthier future for Canadians.”
mRESVIA is currently the only RSV vaccine offered in a pre-filled syringe, providing a convenient, ready-to-use option that streamlines administration, saving time for healthcare professionals and reducing the risk of dosing errors. Moderna expects to supply mRESVIA in Canada by early 2025.
The National Advisory Committee on Immunization (NACI) recommends RSV vaccination for Canadians aged 75 and older and for those aged 60 and above who live in nursing homes or chronic care facilities. For community-dwelling adults aged 60 and older, vaccination is advised as a personal choice after consulting with a healthcare provider.
“With Health Canada’s approval, we’re excited to introduce the first mRNA-based RSV vaccine to Canadians in an efficient pre-filled syringe format,” said Stefan Raos, General Manager of Moderna Canada. “This approval underscores the importance of RSV protection for older adults and highlights our commitment to advancing mRNA technology for public health.”
Health Canada’s approval was based on data from ConquerRSV, a Phase 3 trial involving approximately 37,000 adults aged 60 and older across 22 countries, which showed no serious safety concerns. Moderna continues to seek mRESVIA approvals worldwide.