Moderna, Inc. (NASDAQ:MRNA) announced Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.¹

"Today's approval is an example of how our mRNA platform can help address significant public health challenges like RSV," said Stéphane Bancel, Chief Executive Officer of Moderna. "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 the only RSV vaccine available in a pre-filled syringe. This format offers a convenient, ready-to-use formulation that simplifies the process of administering the vaccine, saving healthcare professionals time and reducing the risk of administrative errors. Supply of mRESVIA is anticipated in Canada in early 2025.

The National Advisory Committee on Immunization (NACI) recommends vaccination against RSV for people in Canada aged 75 years and older, as well as those aged 60 years and older who are residents of nursing homes and other chronic care facilities. Community-dwelling adults aged 60 years and older are recommended for RSV vaccination as an individual decision following consultation with their healthcare provider.

"With Health Canada's approval of mRESVIA for Canadians aged 60 and older, we are proud to bring the first-ever mRNA vaccine against RSV to Canadians in a convenient and efficient pre-filled syringe format," said Stefan Raos, General Manager at Moderna in Canada. "This milestone highlights the importance of vaccination for older adults, who face heightened risks from RSV, and reinforces our dedication to advancing mRNA innovation for meaningful public health impact."

Health Canada's approval is based on data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults aged 60 years and older in 22 countries. No serious safety concerns were identified in the Phase 3 trial. Moderna continues to file for mRESVIA marketing authorizations worldwide.