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DGAP-News: Moderna, Inc. / Key word(s): Miscellaneous
Moderna and the European Commission Agree on Amendment to COVID-19 Vaccine Supply Agreement
The amendment allows participating Member States to have Moderna COVID-19 vaccine booster doses scheduled for delivery in the second quarter of 2022 to be delivered later in calendar year 2022 or early calendar year 2023. Participating Member States will have the possibility to receive the expected updated bivalent booster candidate following approval by the European Medicines Agency.
Moderna's bivalent prototype and Omicron booster vaccine candidate (mRNA-1273.214) is currently being evaluated in a Phase 2/3 study. The Company expects initial data on mRNA-1273.214 in June to inform selection of its candidate for the Northern Hemisphere fall 2022 booster.
Moderna continues to expect advanced purchase agreements of approximately $21 billion for 2022 and continues to believe that COVID market dynamics will result in sales slightly higher in the second half of 2022 than in the first half.
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.
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: the Company’s agreement with the European Commission to amend their originally agreed contractual delivery schedules for the COVID-19 vaccine booster product (mRNA-1273); the potential availability of a bivalent booster vaccine candidate for fall 2022 (which may be mRNA-1273.214); anticipated sales under advanced purchase agreements in 2022 and the associated dollar amounts to be received, which should not be construed as expected 2022 revenue; and dynamics with respect to the anticipated timing for completion of sales in 2022. 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.
Luke Mircea Willats
Director, Corporate Communications
Senior Vice President & Head of Investor Relations
SOURCE: Moderna, Inc.
02.06.2022 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.