Moderna Receives Health Canada Approval For Updated COVID-19 Vaccine Targeting KP.2 Variant Of SARS-COV-2 For Ages Six Months And Older

SPIKEVAX^® is the first updated COVID-19 vaccine authorized in Canada for 2024-2025, offering a timely solution to help protect Canadians this fall and winter season.

Moderna will promptly begin delivery of updated COVID-19 vaccines to the Public Health Agency of Canada, so there is robust supply available in time for provincial and territorial vaccination campaigns.

CAMBRIDGE, MA / ACCESSWIRE / September 17, 2024 / Moderna Inc (NASDAQ:MRNA) today announced that Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX^® KP.2 variant, to help prevent COVID-19 in individuals six months of age and older. Moderna's updated COVID-19 vaccine targets the KP.2 sub-lineage of SARS-CoV-2. With vaccines ready, Moderna will begin delivery of updated doses to the Public Health Agency of Canada, ensuring supply is available in time for provincial and territorial vaccination campaigns.

"As we face another critical season in the fight against COVID-19, we remain steadfast in our dedication to delivering innovative solutions that help protect communities," said Stéphane Bancel, CEO of Moderna. "The authorization of our updated COVID-19 vaccine by Health Canada ensures that Canadians have timely access to the latest vaccines, helping them to stay protected during the upcoming fall and winter months."

Receiving the most recently updated COVID-19 vaccine is expected to provide a better immune response against circulating COVID-19 strains compared to earlier vaccines. It is especially important for those at increased risk for COVID-19 infection or severe COVID-19 illness.¹

"With the recent increase in COVID-19-infections,² staying up to date with your COVID-19 vaccination remains one of the best ways to help protect yourself from severe illness," said Dr. Shehzad Iqbal, Country Medical Director, Moderna Canada. "Canadians are encouraged to speak to their healthcare providers about receiving an updated 2024-2025 COVID-19 vaccine alongside a flu shot this fall."

Health Canada's approval is based on a combination of manufacturing and pre-clinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines.

Highlights for Fall 2024-2025 KP.2 Variant Updated Vaccine:

• The updated vaccine is based on consultations with the Public Health Agency of Canada that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2.

• SPIKEVAX^®will be available in one presentation, allowing adult and pediatric doses to be drawn from the same multidose vial.

• The National Advisory Committee on Immunization (NACI) recommends that anyone not vaccinated or without a known COVID-19 infection in the past three months may receive an updated dose, with a focus on safeguarding vulnerable individuals.¹

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 approval of Moderna's updated KP.2-targeting COVID-19 vaccine by Health Canada; the ability of Moderna's updated COVID-19 vaccine to induce an immune response and provide protection against circulating SARS-CoV-2 variants; and Moderna's ability to supply its COVID-19 vaccine to the Public Health Agency of Canada. 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
[email protected]

Moderna Canada
Sacha Kennedy
Director, Communications and Media
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

¹ Summary of NACI statement of May 3, 2024: Guidance on the use of COVID-19 vaccines during the fall of 2024. Available at: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-guidance-covid-19-vaccines-fall-2024.html Accessed August 27, 2024.

² COVID-19 epidemiology update: Summary: https://health-infobase.canada.ca/covid-19/ Accessed September 3, 2024.

SOURCE: Moderna, Inc.