Moderna Receives Health Canada Authorization for Second Omicron-Targeting Bivalent Booster

mRNA-1273.222 targets BA.4/BA.5 Omicron subvariants and follows the approval of mRNA-1273.214 (SPIKEVAX Bivalent) in Canada, which targets the Omicron BA.1 subvariant

CAMBRIDGE, MA / ACCESSWIRE / November 4, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced Health Canada has authorized the use of its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, 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. The 50 µg booster dose of mRNA-1273.222 includes 25 µg of mRNA encoding for the spike protein of BA.4/BA.5 and 25 µg encoding for the original strain of the SARS-CoV-2 virus.

"This approval demonstrates that our mRNA platform enables rapid development of vaccines and various options to address variants of concern," said Patricia Gauthier, President and General Manager, Moderna Canada. "We are proud to collaborate with Health Canada to bring Omicron-targeting bivalent vaccines to Canada to help broaden population immunity and protect Canadians against current and potential future variants of concern."

Health Canada's authorization of mRNA-1273.222 was based both on pre-clinical data for mRNA-1273.222 as well as clinical data from a Phase 2/3 trial studying mRNA-1273.214. A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.

mRNA-1273.222 is the second Moderna bivalent COVID-19 vaccine approved by Health Canada, following the approval of mRNA-1273.214 (SPIKEVAX Bivalent) in September. Clinical trial data showed that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers against Omicron BA.1 approximately 8-fold above baseline levels. Additional data showed that the higher antibody titers were sustained ninety days after administration.

In addition, mRNA-1273.214 demonstrated significantly higher neutralizing antibody responses against Omicron BA.4/BA.5 compared to mRNA-1273 28 days after administration. Potent responses were also seen against Omicron BA.2.75 28 days after administration, suggesting that the bivalent booster elicits broad cross-neutralization against Omicron variants.

Authorized Use

SPIKEVAX Bivalent Original/Omicron BA.4-BA.5 (elasomeran/davesomeran) 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 over 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 rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. 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 auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight 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-1273.222, or SPIKEVAX Bivalent Original/Omicron BA.4-BA.5); the authorization of mRNA-1273.222 in adults ages 18 years and older by Health Canada; the ability of mRNA-1273.222 to induce higher neutralizing antibody titers against Omicron subvariants BA.4/BA.5 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants, including BA.1, BA.4, BA.5 and BA.2.75 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273) over time and to trigger a strong immune response; the safety, efficacy, and tolerability of mRNA-1273.222 in adults ages 18 and above; and the ability of mRNA-1273.222 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

Luke.Mirceawillats@modernatx.com

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.