Moderna Receives Health Canada Approval for RSV Vaccine for Adults Aged 60 Years and Older

mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against 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 / ACCESSWIRE / November 8, 2024 / Moderna, Inc. (NASDAQ:MRNA) today 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.²

"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.

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 forward-looking 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.

SOURCE: Moderna, Inc.