Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Booster Vaccine

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mRNA-1273.214 is the first Omicron-targeting bivalent COVID-19 booster vaccine approved in Canada

Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273

Approval follows agreement with the Government of Canada to supply 12 million doses of Omicron-targeting bivalent COVID-19 boosters

CAMBRIDGE, MA / ACCESSWIRE / September 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) as a booster dose for active immunization against COVID-19 caused by the SARS-CoV-2 virus in individuals 18 years of age and older. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern (BA.1).

"Health Canada's decision to approve mRNA-1273.214 reinforces the power of our mRNA technology platform, which has enabled us to quickly advance bivalent vaccines that may offer superior protection against Omicron BA.1 and the BA.4 and BA.5 subvariants," said Arpa Garay, Chief Commercial Officer at Moderna. "We believe the potential of mRNA-1273.214 to provide broad immunity to Omicron variants may help Canadians stay ahead of the COVID-19 virus as we move into the fall and winter months."

The Health Canada decision is based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. Additional analysis showed mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.

On August 22, 2022, Moderna announced an agreement with the Government of Canada to supply 12 million doses of Omicron-containing bivalent COVID-19 boosters. As part of that agreement, the Government exercised its option to purchase an additional 4.5 million doses of a bivalent vaccine from Moderna, in addition to moving forward the scheduled delivery of 1.5 million bivalent doses from 2023 to 2022. There was also an agreement to convert an additional six million doses of the company's original COVID-19 vaccine (Spikevax, mRNA-1273) to mRNA-1273.214. Supply is expected to commence in early September.

"As the Omicron variant and its subvariants continue to spread broadly within Canada, there is a critical need to provide updated boosters designed to better match the circulating strain, particularly before respiratory virus season reaches its peak," said Patricia Gauthier, President and General Manager, Moderna Canada. "Today's mRNA-1273.214 approval provides Canadians with an important new tool in the fight against COVID-19 and a means of better protecting vulnerable populations."

In addition to Canada, Moderna has received approval for mRNA-1273.214 in the UK, Australia, and Switzerland and has completed regulatory submissions for the next-generation vaccine worldwide.

Authorized Use

Spikevax Bivalent (elasomeran/imelasomeran) Original/Omicron mRNA vaccine is indicated as a booster dose for active immunization against COVID-19 caused by the severe acute respiratory syndrome SARS-CoV-2 virus in individuals 18 years of age and older.

About Moderna

In 10 years since its inception, 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 in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators. 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'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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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 regarding: the development of the Company's COVID-19 Vaccine (mRNA-1273.214, or Spikevax Bivalent Original/Omicron); the authorization of mRNA-1273.214 in adults ages 18 years and older by Health Canada; the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants BA.4 and BA.5 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); the safety, efficacy, and tolerability of mRNA-1273.214 in adults ages 18 and above; and the ability of mRNA-1273.214 to protect against COVID-19. 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 those other 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, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, 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 hereof.

Moderna Contacts

Media:
Luke Mircea Willats
Director, Corporate Communications
[email protected]

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

SOURCE: Moderna, Inc.



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