Moderna’s mRNA RSV Vaccine Receives Health Canada Approval For Adults Aged 60 Years And Over
- mRESVIA™ is Moderna’s second approved product in Canada and is the first mRNA vaccine for RSV and
the only one in single-dose pre-filled syringes - Canada is the fourth jurisdiction to approve mRESVIA following approvals in the U.S., Europe, and Qatar
CAMBRIDGE, MA – Moderna, Inc. (Nasdaq:MRNA) announced Health Canada
has approved mRESVIA™ (Respiratory Syncy-al 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, readyto-
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 RSV vaccination as an individual decision following consultation with their healthcare
provider.2
“With Health Canada’s approval of mRESVIA for Canadians aged 60 and older, we are proud to bring the
first-ever mRNA vaccine for RSV to Canadians in a convenient and efficient pre-filled syringe format,”
said Stefan Raos, General Manager at Moderna 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 ages 60 years or older in 22 countries. No serious safety
concerns were identified in the Phase 3 trial. Moderna continues to file for mRESVIA marketing
moderna authorizations worldwide, further advancing the company’s mission to protect populations from
preventable respiratory diseases.
About mRESVIA™
mRESVIA is an RSV vaccine that consists of an mRNA sequence encoding RSV glycoprotein F stabilized in
the prefusion conformation. The F glycoprotein is expressed on the surface of the virus and is required
for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a
significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B
subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccine.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA
technology, Moderna is reimagining how medicines are made and transforming how we treat and
prevent disease for everyone. By working at the intersection of science, technology and health for more
than a decade, the company has developed medicines at unprecedented speed and efficiency, including
one of the earliest and most effective COVID-19 vaccines.
Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious
diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global
team driven by Moderna values and mindsets to responsibly change the future of human health,
Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more
information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter),
Facebook, Instagram, YouTube and LinkedIn.
Moderna Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, as amended, including statements regarding: the potential for mRESVIA
to reduce disease burden from RSV, and the safety of mRNA-1345; Moderna’s expectation to supply
mRESVIA in Canada in early 2025; and Moderna’s mRESVIA marketing authorizations worldwide. The
forward-looking statements in this press release are neither promises nor guarantees, and you should
not place undue reliance on these forward-looking statements because they involve known and
unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control, and
which could cause actual results to differ materially from those expressed or implied by these forwardlooking
statements. These risks, uncertainties, and other factors include, among others, those risks and
uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2023 and in subsequent filings made by Moderna with the U.S.
Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. Except
as required by law, Moderna disclaims any intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the event of new information, future
developments or otherwise. These forward-looking statements are based on Moderna’s current
expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
International media
Luke Mircea-Willats
Senior Director, International Communications
luke.mirceawillats@modernatx.com
Moderna Canada
Sacha Kennedy
Director, Communications and Media
sacha.kennedy@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
lavina.talukdar@modernatx.com
References
1 mRESVIA™ Product Monograph.
2 Respiratory syncytial virus (RSV) vaccines: Canadian Immunization Guide. Available at:
https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-
4-active-vaccines/respiratory-syncytial-virus.html. Accessed September 23, 2024.
Original source here.