EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for The Use of The Moderna Covid-19 Vaccine in Children (6-11 Years) In the European Union

Announcement follows CHMP's previous decision to adopt a positive opinion recommending marketing authorization for Moderna's COVID-19 vaccine to include adolescents 12 years of age and older.

CAMBRIDGE, MA / ACCESSWIRE / February 24, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the conditional marketing authorization (CMA) to include a 50 µg two-dose series of Spikevax, the Company's vaccine against COVID-19, in children ages 6-11 years. Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Spikevax in children ages 6-11 years.

"The CHMP recommendation to authorize the use of our COVID-19 vaccine in children ages 6-11 years in Europe is an important milestone. It highlights the effectiveness and safety of our vaccine in this age group and helps to keep our children safe and able to experience a normal school and family life," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful to the CHMP for their thorough review of our submission and look forward to an authorization decision from the European Commission."

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 the CHMP from over 4,000 children demonstrated that vaccination of children ages 6-11 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 18-25 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). The ClinicalTrials.gov identifier is NCT04796896.

The EMA has also recommended updates to the summary of product characteristics (SmPC) for the use of Spikevax in the European Union. The booster dose of 50 µg indicated for individuals 18 years of age and older, is now recommended at least three months following the second dose. This timing has been shortened from the previously approved timeframe of six months. The changes also include the possibility to administer a heterologous (mix-and-match) booster dose, such as Spikevax, following completion of primary vaccination with another authorized COVID-19 vaccine.

Moderna recently announced that the Therapeutic Goods Administration in Australia also granted provisional registration for the use of the Company's mRNA COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children ages 6-11 years.

Authorized Use

SPIKEVAX (elasomeran mRNA vaccine) has been granted Conditional Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency and is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals six years of age and older. A booster dose may be given at least three months after the second dose for people aged 18 years 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: development of the Company's COVID-19 Vaccine (mRNA-1273, or Spikevax); the potential approval of the vaccine in children ages 6-11 by the European Commission following the positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use; and the safety, efficacy and tolerability of the vaccine in children ages 6-11. 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.

Moderna Contacts:

Media:

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

Investors:

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

SOURCE: Moderna, Inc.