Moderna Files for Authorization of its COVID-19 Vaccine with Health Canada to Include Children Ages 6-11 Years

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Submission based on Phase 2/3 study of SPIKEVAX in children ages 6 to 11

CAMBRIDGE, Mass.Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization with Health Canada for the evaluation of a 50 µg two-dose series of SPIKEVAX™ (elasomeran mRNA vaccine)1 in children ages 6 to 11 years.

“We are pleased to announce that we have submitted for authorization of a 50 µg two-dose series of our COVID-19 vaccine for use in children 6 to 11 years old with Health Canada,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are encouraged that the Moderna COVID-19 vaccine at the 50 µg dose level helped prevent SARS-CoV-2 infection in children. We plan to submit these data to other regulatory agencies around the world to protect this important younger age population with our COVID-19 vaccine.”

The Phase 2/3 “KidCOVE” study of SPIKEVAX in pediatric population ages 6 months to under 12 years is ongoing. Moderna recently shared new data from the KidCOVE study in children ages 6 years to 11 years. Vaccine efficacy of 100% using the Phase 3 COVE study primary case definition for COVID-19 was observed two weeks after the first dose of SPIKEVAX at the 50 µg dose level. Additionally, for asymptomatic infection two weeks after the first dose, vaccine efficacy was 65% (95% CI: .16, .85). For SARS-CoV-2 infection regardless of symptoms,​ vaccine efficacy was 80% (95% CI: .62, .90) two weeks after the first dose. On October 24, the Company announced positive top line data in children 6 to 11 years of age. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 μg doses of SPIKEVAX were generally well tolerated2.

The KidCOVE study3 is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50 µg doses of mRNA-1273 given to healthy children 28 days apart. The study population is divided into 3 age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years).

On September 16, 2021, Health Canada approved the New Drug Submission (NDS-CV) for SPIKEVAX for active immunization to prevent COVID-19 in individuals 12 years of age and older. More recently, on November 12, 2021 Health Canada authorized the use of a 50 µg booster dose for individuals aged 18 and older administered at least six months after completion of the primary series.

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 six 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 and at unprecedented speed. 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 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.

AUTHORIZED USE IN CANADA

SPIKEVAX (elasomeran mRNA vaccine) has been granted approval by Health Canada and is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 12 years of age and older.

IMPORTANT SAFETY INFORMATION

• Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX.

• Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of SPIKEVAX. Monitor SPIKEVAX recipients for the occurrence of immediate adverse reactions .

• Post-marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.

• Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

• Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to SPIKEVAX.

• SPIKEVAX may not protect all vaccine recipients.

• Adverse reactions reported in clinical trials following administration of SPIKEVAX include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.

• The following adverse reactions have been reported following administration SPIKEVAX during mass vaccination outside of clinical trials:

o Severe allergic reactions, including anaphylaxis

o Myocarditis and pericarditis

o Syncope

• Available data on SPIKEVAX administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of SPIKEVAX on the breastfed infant or on milk production/excretion.

• There are no data available on the interchangeability of SPIKEVAX with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of SPIKEVAX should receive a second dose of SPIKEVAX to complete the vaccination series.

• Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of SPIKEVAX.

• If a patient experiences a side effect following immunization, healthcare professionals should complete the Adverse Events Following Immunization (AEFI) Form appropriate for the province/territory (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) and send it to the local Health Unit.

The full product monograph is available at the Health Canada website:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html and https://www.modernacovid19global.com/ca/.

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 a vaccine against COVID-19 (mRNA-1273); the Company’s application for, and potential authorization of, the administration of mRNA-1273 in children ages 6 to 11 years old in Canada; the effectiveness of mRNA-1273 at preventing infection with COVID-19 and the safety and tolerability of mRNA-1273 in pediatric populations; and the conduct of clinical trials for mRNA-1273 in pediatric populations. 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 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.

___________________________

1  

BARDA, part of ASPR within the U.S. HHS is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034 BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.

2  

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19

3  

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). The ClinicalTrials.gov identifier is NCT04796896.

 

Moderna Contacts

Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com

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

Source: Moderna, Inc.