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 forwardlooking
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
617-209-5834
Lavina.Talukdar@modernatx.com
References
1mRESVIA™ Product Monograph.
2Respiratory syncytial virus (RSV) vaccines: Canadian Immunization Guide. Available at: https://www.canada.ca/en/publichealth/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html Accessed
September 23, 2024.
SOURCE: Moderna, Inc.