Moderna announces Health Canada authorization of the SPIKEVAX mRNA COVID-19 vaccine for children aged six to 11 years

Sample article from our Government & Public Policy

CAMBRIDGE, Massachusetts , March 18, 2022 (press release) –

 

Announcement follows recent authorization of the Company's mRNA COVID-19 vaccine in Australia and the European Union for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, SPIKEVAX™, in a two-dose series of 50 µg per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to11 years. The announcement follows the recent authorization of the Company's COVID-19 vaccine in the same age group in both Australia and the European Union.

"Health Canada was the first regulator to fully approve our COVID-19 vaccine, and we are pleased they have taken this important step to expand this authorization to children aged 6 to11 years," said Stéphane Bancel, Chief Executive Officer of Moderna. "I want to thank the Government of Canada for their partnership and the trust this decision shows in the effectiveness and safety of our vaccine in this important patient population."

Moderna's vaccine was investigated in the ongoing Phase 2/3 "KidCOVE" study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of SPIKEVAX (mRNA-1273) given to healthy children 28 days apart. Data submitted to Health Canada from over 4,000 children demonstrated that vaccination of children aged 6 to11 years with a 50 μg mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18 to 25 years old from the Phase 3 COVE study. Positive direct efficacy of two 50 μg doses of mRNA-1273 was also demonstrated, and vaccination was generally well tolerated.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). Over 400 children in Canada were randomized into the study and the ClinicalTrials.gov identifier is NCT04796896.

Recently, the Therapeutic Goods Administration in Australia and the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) authorized Moderna's mRNA COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to 11 years.

Authorized Use

Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, SPIKEVAX (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older.

About Moderna

In 10 years since its inception, Moderna has transformed from a science 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 ground-breaking 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 seven years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This post 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, or SPIKEVAX); the approval of the vaccine in children ages 6 to 11 by Health Canada; and the safety, efficacy, and tolerability of the vaccine in children ages 6 to 11. 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 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 post 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.

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Dan Rivard
Dan Rivard
- VP Market Development -

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