Moderna Switzerland GmbH, the International Operations headquarters of Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided a distribution update for the COVID-19 Vaccine Moderna in the European Union and the EEA Member States, Norway and Iceland, including the beginning of deliveries of the vaccine on Monday, January 11, 2021.
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All shipments of the COVID-19 Vaccine Moderna will be conducted by Kuehne+Nagel, a world-leading logistics company, and will originate from its centralized pharma hub in Europe. Vaccine shipments will be delivered to one pre-agreed central location within each Member State, at which point Member States will coordinate national distribution.
Dan Staner, Vice President and Head of region EMEA, said: “This is a really exciting milestone, and we’re proud of the role Moderna’s vaccine will play in tackling this pandemic in Europe. Distribution across the European Union is one of the largest logistical undertakings that Moderna has faced since starting this platform ten years ago. I am in awe of the dedicated team that has got us here, and I am indebted to all the partners, suppliers and the European Commission for their help and support in achieving this important milestone.”
“This is an important day for Europe and its citizens in the fight against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The Moderna team has worked tirelessly to deliver a vaccine with 94% efficacy in less than 12 months since the virus emerged. This may be the first medicine that we have brought to Europe, but we are working on many more – such as vaccines against cytomegalovirus and the flu, to help protect even more people.”
Manufacturing of the COVID-19 Vaccine Moderna vaccine drug substance is performed by Lonza at its site in Switzerland, with aseptic drug product manufacturing and fill-finish performed by ROVI in Spain. Additional aseptic drug product manufacturing and fill-finish support will be provided by Recipharm in France within the first half of 2021.
On December 18, 2020, the European Commission exercised its option to order an additional 80 million doses of Moderna’s vaccine against COVID-19, bringing its confirmed order commitment to 160 million doses in 2021.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., and with operations in Switzerland, Spain and Canada, Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six 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 Company’s development of a vaccine against the novel coronavirus, and the timeline for the delivery of the Moderna COVID-19 Vaccine to Member States of the European Union and EEA. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our fil ings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data
submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarte rly Report on Form 10-Q 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.
Moderna:
Media:
Harriet Barham
Director, FTI Consulting
+32 474-819-629
Harriet.Barham@fticonsulting.com
modernamedia@fticonsulting.com
- Dolleen Hussey
- Director, Corporate Communications
617-335-1374
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
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