EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union
Moderna has received approval for omicron-targeting bivalent boosters in the United States,?Australia, Switzerland, and the UK?to date?and?has completed regulatory submissions?worldwide.
In 10 years since its inception, Moderna has transformed from a 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 both clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators. 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 autoimmune 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 press release 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-1273.214, or Spikevax bivalent Original/Omicron BA.1); the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) adoption of a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older; the potential authorization of mRNA-1273.214 as a booster dose for immunization to prevent COVID-19; the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants BA.4 and BA.5 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); the safety, efficacy, and tolerability of mRNA-1273.214; and the ability of mRNA-1273.214 to protect against COVID-19. 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 for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each 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.
Media: Luke Mircea Willats Director, Corporate Communicationsluke.email@example.com
Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
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