European Medicines Agency Accepts Moderna's Conditional Marketing Authorization Filing for its Omicron BA.4/BA.5 Targeting Bivalent COVID-19 Vaccine
- Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, in September
- Moderna's Omicron-targeting bivalent boosters now authorized in the United States, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK
CAMBRIDGE, MA / ACCESSWIRE / September 28, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency (EMA) has accepted a variation for the evaluation of a 50 µg booster dose of the Omicron-containing bivalent COVID booster candidate, mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) in adults 12 years and older. Spikevax bivalent Original/Omicron BA.4-5 is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.4/BA.5).
"We are proud to announce this filing for the use of our bivalent COVID-19 vaccine targeting the BA.4/BA.5 Omicron subvariants in the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "Following the recent approval of our BA.1 targeting vaccine in Europe, our BA.4/BA5 Omicron targeting vaccine will now bring a second option to help protect people across Europe as we head into the winter months."
mRNA-1273.222 targets both the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain. Moderna's submission to the EMA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, which recently received EMA approval.
Moderna has received authorizations for Omicron-targeting bivalent boosters in the United States, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK to date and has submitted regulatory applications worldwide.
In over 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 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 groundbreaking 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 press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the potential authorization by European Union health officials of an mRNA-1273.222 booster dose in adults 12 years of age and older; the potential for mRNA-1273.222 to provide protection from COVID-19, including emerging variants; and Moderna's global regulatory applications. 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 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.
Luke Mircea Willats
Director, Corporate Communications
Senior Vice President & Head of Investor Relations
SOURCE: Moderna, Inc.
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