Moderna announces that Health Canada approves its COVID-19 vaccine

CAMBRIDGE, Mass.– (BUSINESS WIRE) – Sept. 16, 2021–

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, today announced Health Canada approved the New Drug Submission (PDN-CV) for SPIKEVAX ™ (elasomeran mRNA vaccine), known as the Moderna COVID-19 vaccine, for active immunization to prevent COVID-19 in people 12 years of age years and older.

“Health Canada’s approval of our COVID-19 vaccine is an important milestone as this is our first full approval for Spikevax. I want to thank Health Canada for their hard work throughout the process, ”said Stephane Bancel, CEO of Modern. “I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in the fight against the COVID-19 pandemic. ”

Health Canada approved the new drug submission for SPIKEVAX based on clinical data of the Phase 3 COVE study of the Moderna COVID-19 vaccine, which recruited more than 30,000 participants in the we In the final analysis of data from the Phase 3 COVE study, SPIKEVAX showed 93% efficacy, with efficacy remaining lasting up to six months after administration of the second dose. The safety profile based on an extended safety follow-up was consistent with the main results of the phase 3 COVE study.

The Moderna COVID-19 vaccine was initially licensed in Canada under an emergency order for persons 18 years of age and over granted by Health Canada to December 23, 2020. At August 27, 2021, Health Canada Expanded the authorization of the Interim Order for the Moderna COVID-19 vaccine to include adolescents 12 years of age and older.

About SPIKEVAX

Moderna COVID-19 vaccine, branded SPIKEVAX, is a COVID-19 mRNA vaccine encoding a pre-fused stabilized form of the Spike (S) protein. At December 18, 2020, the we The FDA has cleared the Moderna COVID-19 vaccine for emergency use in people 18 years of age or older. Modern has received emergency (or other conditional, interim or provisional) authorization for the use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use List (EUL) of the World Health Organization (WHO).¹

On Modern

In 10 years since its creation, Modern has grown from a company in the scientific research stage offering programs in the field of messenger RNA (mRNA), to a company with a diverse clinical portfolio of vaccines and therapeutic products across six modalities, a broad portfolio of intellectual property in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at unprecedented speed. Modern maintains alliances with a wide range of domestic and foreign government and business collaborators, which has enabled the pursuit of both groundbreaking science and rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest 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 enabled the development of therapies and vaccines for them. infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Modern was named one of the top biopharmaceutical employers by Science for six years. To learn more, visit www.modernatx.com.

USE AUTHORIZED IN CANADA

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

IMPORTANT SAFETY INFORMATION

• Do not administer SPIKEVAX to people with a known history of a serious allergic reaction (eg, anaphylaxis) to any of the ingredients of SPIKEVAX.

• Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of SPIKEVAX. Monitor recipients of SPIKEVAX for the occurrence of immediate adverse reactions based on Centers for Disaster Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

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

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

• People who are immunocompromised, including people receiving immunosuppressive therapy, may have a decreased response to SPIKEVAX.

• SPIKEVAX may not protect all vaccinees.

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

• The following side effects have been reported following the administration of SPIKEVAX during mass vaccination outside of clinical trials:

o Severe allergic reactions, including anaphylaxis

o Myocarditis and pericarditis

o Syncope

• The data available on SPIKEVAX administered to pregnant women are insufficient to clarify the risks associated with the vaccine during pregnancy. No data are available to assess the effects of SPIKEVAX on the breast-fed infant or on milk production / excretion.

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

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

• If a patient experiences a side effect after vaccination, healthcare professionals should complete the Adverse Events Following Vaccination (AEFI) form appropriate for the province / territory (https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-after-immunization/form.html) and send it to the local health unit.

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 efficacy and safety of the Company’s vaccine against COVID-19 (mRNA-1273), SPIKEVAX brand. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve risks, uncertainties and other known and unknown 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 the other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent annual report on Form 10-K filed with the United States Securities Commission (SEC) and in subsequent filings made by Modern with the SECOND, which are available on the SEC’s website at www.sec.gov. Unless required by law, Modern disclaims any intention or responsibility to update or revise 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, member of the ASPR within the we The 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 reimburses Modern for 100 percent of the eligible costs incurred by the Company to carry out the program described in the BARDA contract. The we the government agreed to purchase the supply of mRNA-1273 under US Department of Defense contract n ° W911QY-20-C-0100.

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Colleen HusseyDirector, Corporate Communications

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Source: Moderna, Inc.