Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Vaccine in Children & Adolescents (6-17 Years)

The recommendation is based on clinical data for Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA.1273.214

Moderna's bivalent Omicron-targeting COVID-19 vaccines (mRNA.1273.214 (BA.1) & mRNA.1273.222 (BA.4/5)) are currently authorized for use in individuals 18 years of age and older in Canada

Both bivalents have been shown to trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/5) in Phase 2/3 clinical trials

CAMBRIDGE, MA / ACCESSWIRE / February 17, 2023 / 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 (SpikevaxBivalent Original/Omicron) in children and adolescents 6 to 17 years of age. The authorizations are based on a 25 µg booster dose for children ages 6 to 11 years old and a 50 µg booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster.

"The authorization of a booster dose of mRNA-1273.214 in children and adolescents is a critical step to broaden protection against the Omicron family of variants, and the emergence of new variants of concern in Canada," said Stéphane Bancel, Chief Executive Officer of Moderna. "This decision highlights the effectiveness and safety of our vaccine in this important age group."

The pediatric and adolescent authorization is based on clinical trial booster data for Moderna's original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. The application described data from a 25 µg booster dose administered to children ages 6 to 11 years old and a 50 µg booster dose for adolescents 12 to 17 years old, following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214.

"We are pleased with Health Canada's authorization of our bivalent booster for children and adolescents and our continued collaboration to provide boosters to help protect all Canadians from current and future COVID-19 variants of concern, especially as this virus continues to circulate across the country and around the world," said Shehzad Iqbal, Country Medical Director of Moderna Canada.

In November 2022, Moderna announced that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/BA.5) in Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.

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 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 autoimmune 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 Company's development of bivalent vaccine candidates against COVID-19 (mRNA-1273.222 and mRNA-1273.214); the ability of mRNA-1273.214 to protect children against COVID-19; the ability of mRNA-1273.214 and mRNA-1273.222 to induce higher neutralizing antibody titers against Omicron variants in adults than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); and authorization of mRNA-1273.214 in Canada for administration in children and adolescents ages 6-17 by Health 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K and the Quarterly Report on Form 10-Q for the quarter 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 of this press release.

Moderna Contacts:

International Media:

Luke Mircea Willats
Senior Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

Canada Media:

Sacha Kennedy
Director, Communications & Media Relations, Canada
sacha.kennedy@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.