Moderna files a dossier to extend the conditional marketing authorization for its COVID-19 vaccine in the European Union to include children aged 6 to 11

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CAMBRIDGE, Mass .– (COMMERCIAL THREAD) – Moderna Inc. (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, today announced that it has filed a request to amend the authorization of conditional marketing (AMC) to the European Medicines Agency (EMA) for the evaluation of a series of two doses of 50 µg of mRNA-12731 in children 6 to 11 years old.

“We are pleased to announce the submission of this variation to the EMA for the use of our COVID-19 vaccine in children aged 6 to 11 in the European Union. This is our first submission for the use of our vaccine in this age group, ”said Stéphane Bancel, CEO of Moderna. “We are encouraged that the Moderna COVID-19 vaccine at the 50 µg dose level has helped prevent SARS-CoV-2 infection in children. We plan to submit this data to other regulators around the world to protect this important younger population with our COVID-19 vaccine. ”

The phase 2 “KidCOVE” study of mRNA-1273 in the pediatric population aged 6 months to less than 12 years is ongoing. Moderna recently shared new data from the KidCOVE study on mRNA-1273 in children aged 6 to less than 12 years old. 100% vaccine efficacy using the P301 primary case definition for COVID-19 was observed two weeks after the first dose of mRNA-1273 at the 50 µg dose level. In addition, for asymptomatic infection two weeks after the first dose, vaccine efficacy was 65% (95% CI: 0.16, 0.85). 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 Society announcement Positive first-line data from phase 2/3 mRNA-1273 study in children 6 to 2.

The KidCOVE study is a randomized, observer-blind, placebo-controlled extension study to evaluate the safety, tolerability, reactogenicity and efficacy 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

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Secretary assistant. for preparedness and response to the US Department of Health and Human Services (HHS). The ClinicalTrials.gov the username is NCT04796896.

On 23 July 2021, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommend Marketing Authorization for Moderna’s COVID-19 Vaccine (Spikevax) to include adolescents 12 years of age and older.

About Moderna

In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the field of messenger RNA (mRNA), to a company with a diverse clinical portfolio of vaccines and therapeutic products. through six modalities, a broad portfolio of intellectual property in areas such as the formulation of mRNA and lipid nanoparticles, and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at low speed. previous. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed 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. Moderna was named one of the top biopharmaceutical employers by Science since seven years. To learn more, visit www.modernatx.com.

AUTHORIZED USE IN THE EU

Spikevax ▼ (COVID-19 Vaccine Moderna) has obtained conditional marketing authorization from the European Commission for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people 12 years of age and older .

IMPORTANT SAFETY INFORMATION

  • Do not give 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 as directed by the Centers for Disease Control and Prevention (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 people who are vaccinated.

  • 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 injection site. injection and erythema at the injection site, and rash.

  • Cases of anaphylaxis and other severe allergic reactions, myocarditis, pericarditis and syncope have been reported following administration of Spikevax during mass vaccination outside of clinical trials.

  • There are insufficient data available on Spikevax given to pregnant women to inform about 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.

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

  • The black equilateral triangle indicates that additional monitoring is needed to capture any adverse reactions. This will allow rapid identification of new security information. Individuals can help by reporting any side effects they may be experiencing. Side effects can be reported to EudraVigilance (https://www.adrreports.eu/) or directly to Moderna using the email [email protected]

For complete information on the safety of Spikevax, please always refer to the approved summary of product characteristics and the package leaflet available in all European Union languages ​​on the EMA website.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, in particular concerning: the development by the Company of a vaccine against COVID-19 (mRNA-1273); the Company’s application and potential authorization for the administration of mRNA-1273 to children aged 6 to 11 years in the European Union; the efficacy of mRNA-1273 in preventing infection with COVID-19 and the safety and tolerability of mRNA-1273 in pediatric populations; and conducting clinical trials for mRNA-1273 in pediatric populations. 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 State Securities and Exchange Commission (SEC). United and in subsequent filings 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 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.


1BARDA, which is part of the ASPR within the US HHS, supports the continued research and development of the company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034 BARDA reimburses Moderna 100 percent of the eligible costs incurred by the Company for the conduct of the program described in the BARDA contract. The US government has agreed to purchase the supply of mRNA-1273 under 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


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