News Details

CAMBRIDGE, MA / ACCESSWIRE / July 22, 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 booster dose of Spikevax, the Company's COVID-19 vaccine, at the 50 µg dose level for adolescents (12-17 years) at least three months after completion of the primary series.

"The recommendation to authorize the use of a booster dose of Spikevax in adolescents ages 12-17 is an important step to continue to protect this age group from COVID-19 and the emergence of new variants of concern," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful to the CHMP for their comprehensive review of our submission and look forward to an authorization decision from the European Commission."

The CHMP based this positive opinion on scientific evidence shared by the company, including comprehensive safety data. The administration of a booster dose of 50 µg at least three months after administration of completion of the primary series is predicted to substantially increase the immune responses against variants of concern, including Omicron compared to pre-boost levels.

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 12 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 COVID-19 booster vaccine in adolescents ages 12-17 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 booster vaccine in adolescents ages 12-17. 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.