MODERNA RECEIVES HEALTH CANADA AUTHORIZATION FOR UPDATED COVID-19 VACCINE FOR AGES SIX MONTHS AND OLDER

SPIKEVAX^® XBB.1.5 is the first updated COVID-19 vaccine authorized in Canada for fall 2023

Provinces and territories will have access to updated COVID-19 vaccines for their respective fall vaccination campaigns

TORONTO, Sept. 12, 2023 /CNW/ - Moderna Biopharma Canada Corp. today announced Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX^® XBB.1.5, to prevent COVID-19 in individuals 6 months of age and older.ⁱ  Now approved for use, Moderna's updated COVID-19 vaccine will be available to provinces and territories to coordinate their fall vaccination campaigns.

"COVID-19 continues to present a serious health risk.ⁱⁱ With the authorization of our updated vaccine, Canadians have an important tool to help protect themselves, especially as we approach the peak of the respiratory virus season," said Shehzad Iqbal, Country Medical Director, Moderna Canada. "The National Advisory Committee on Immunization (NACI) recommends that anyone not vaccinated or without a known COVID infection in the past six months should receive an updated dose, with a focus on safeguarding vulnerable individuals."ⁱⁱⁱ

To ensure updated vaccines provide the most robust immune response against the dominant circulating variants, regulators and global public health agencies recommended that COVID-19 vaccines be updated to a monovalent XBB.1.5 composition. Moderna's submission to Health Canada contained clinical data showing an immune response against SARS-CoV-2 XBB sublineages including XBB.1.5 and XBB.1.16.

In addition to the data included in the submission, Moderna has recently released further clinical trial data concerning the ongoing evaluation of SPIKEVAX XBB.1.5 against circulating subvariants like BA.2.86, EG.5, and FL.1.5.1. In August, Moderna announced additional clinical trial data which showed the company's updated COVID-19 vaccine elicited an immune response in humans against EG.5 and FL.1.5.1.^iv Last week, the company shared additional clinical trial data confirming that the updated vaccine also elicited a human immune response against BA.2.86.^v

Two key updates that aim to simplify administration and support provincial vaccination programs are included in this authorization. SPIKEVAX XBB.1.5 will be available in one presentation (0.1 mg/mL 2.5mL vial) allowing for adult and pediatric doses to be drawn from the same vial. Dosing has also been adapted to simplify the administration considerations, which require only the patient's age and prior vaccination history to determine the appropriate dose.

Since its inception in 2010, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.  

Moderna has established relationships with government and commercial collaborators, which have allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. In Canada, Moderna has a 10-year strategic partnership with the Canadian government to enhance pandemic response capabilities, which includes building an advanced mRNA manufacturing facility for respiratory vaccines currently under construction in Quebec.  Moderna is also committed to helping position Canada as a leader in mRNA research and development with partnerships across the country. To learn more, visit www.modernatx.com/en-CA

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SOURCE Moderna, Inc.