Business Wire

European Commission Purchases Additional 150 Million Doses of COVID-19 Vaccine Moderna

Share

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission purchased an additional 150 million doses of the COVID-19 Vaccine Moderna, which are scheduled to be delivered in the third and fourth quarter of 2021. This brings its confirmed order commitment to 310 million doses for delivery in 2021.

Under the terms of the agreement, the European Commission has the option to purchase an additional 150 million doses to be delivered in 2022.

“We appreciate the European Commission’s confidence in Moderna and our mRNA platform. Today’s purchase of an additional 150 million doses brings their total order of our COVID-19 vaccine to 310 million for delivery in 2021,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The European Commission is in discussions with us on how to prepare for 2022, including addressing potential variants, and the Commission has an option for an additional 150 million doses for delivery in 2022. Moderna is committed to working relentlessly to bring to market vaccine boosts with the relevant variants to address this global pandemic.”

The European Commission granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. Deliveries of COVID-19 Vaccine Moderna to European countries have to date come from Moderna’s dedicated non-U.S. supply chain.

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the U.S. National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the U.S. National Institutes of Health (NIH) on February 24, 2020, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On May 12, 2020, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.

Authorized Use

The COVID-19 Vaccine Moderna has been granted a Conditional Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency, which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

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., 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 plans for the supply and distribution of the COVID-19 Vaccine Moderna to Member States of the European Union, as well as the timing for that supply. 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 filings, 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 Quarterly 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.

Contact information

Moderna Contacts:
Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com

Harriet Barham
Director, FTI Consulting
+32 474-819-629
Harriet.Barham@fticonsulting.com
modernamedia@fticonsulting.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

C3 AI and Baker Hughes to Provide Enterprise AI Solutions to Accelerate PETRONAS Digital Transformation Program26.2.2021 17:00:00 EETPress release

C3 AI (NYSE: AI) and Baker Hughes today announced an artificial intelligence (AI) collaboration with PETRONAS, a global energy and solutions company from Malaysia, to apply BakerHughesC3.ai (BHC3) technology across PETRONAS’s strategic digital transformation programs. As the custodian of Malaysia's national oil and gas resources, PETRONAS runs an extensive digital transformation program across energy operations to extract value from data. The adoption of AI as part of its overall program for improved oil and gas productivity, asset integrity, and safety supports PETRONAS’s commitment to provide clean, efficient energy solutions by harnessing the power of technology. PETRONAS will work with energy technology, data science, and AI experts at Baker Hughes and C3 AI to collaborate on projects focused on improved reliability of energy assets in critical operations. Utilizing Microsoft Azure, PETRONAS will deploy the BHC3™ Reliability application to further improve maintenance programs for g

Avania in Position for Next Stage of Growth26.2.2021 16:00:00 EETPress release

Avania, a leading global full-service contract research organization (CRO) focused on medical technology (MedTech) development, today announced that it has successfully refinanced its existing banking facilities with Crescent Capital Group. “This new banking facility allows us to accelerate our next phase of organic and acquisitive growth over the next few years,” said Edo van Houten, CFO of Avania. “This transaction is also a reflection of the progress we have made in our brand strategy and position in the market, and it demonstrates the confidence of the financial community in our operational and strategic plan.” Avania has navigated confidently through the COVID-19 pandemic, posting a strong year of growth in 2020 despite the pandemic. The company will continue its growth trajectory as a global MedTech-focused CRO, supporting products from concept through post-market support. MedTech is all Avania does, navigating innovative medical technologies to market effectively and efficiently

Ipsen Receives Positive CHMP Opinion Recommending Cabometyx® in Combination With Opdivo® as First-line Treatment for Patients Living With Advanced Renal Cell Carcinoma26.2.2021 14:37:00 EETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). The European Commission, which has the authority to approve medicines for the European Union (E.U.), will now review the CHMP recommendation and a final decision on the application in the E.U. is expected in the coming months. “Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world. We’re proud to be able to share that the CHMP has confirmed a positive recommendation for Cabometyx® in combination with Opdivo®, bringing this impactful new treatment option one step closer for patients,” said Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen. “At Ipsen, w

Hiro Capital Leads $15 Million of Games VC Investment Into Snowprint Studios, Double Loop Games and Happy Volcano Games26.2.2021 11:55:00 EETPress release

Three international video game studios are the latest investments for Hiro Capital, the entrepreneur-led Venture Capital fund focused on backing innovators in Video Games, the Metaverse, Esports and Digital Fitness. The three mobile and cross-platform studios – Snowprint in Stockholm/Berlin, Double Loop Games in San Francisco and Happy Volcano in Belgium – will use Hiro’s investment to expand their development pipelines and accelerate global growth. They join UK and US Games studios Flavourworks, Polyarc and Lightfox in the Hiro Capital portfolio, alongside pioneers in the gamification of Games Streaming and Digital Fitness LIV.tv, Edgegap, FitXR and Nurvv. Ian Livingstone, co-founding partner at Hiro Capital, said, "We are excited to begin 2021 by announcing Hiro's investment in three amazing games studios, Snowprint, Double Loop and Happy Volcano. Each studio has demonstrated innovation and expertise in developing fun to play games which resonate with today’s audiences. I’m especiall

Inspur Information Releases 2020 Global Computing Index Report26.2.2021 11:07:00 EETPress release

Inspur Information, a leading IT infrastructure solutions provider, has sponsored an International Data Corporation (IDC) white paper on the 2020 Global Computing Index (henceforth referred to as The Report). As the world’s first index report on computing, The Report unveils the relationship between computing power and economic development and serves as a reference for the outlook of the global digital economy. Global digital transformation has entered a phase marked by exponential growth in innovation, with the size of the digital economy projected to continue on an upward trend. As a key factor that underlies digital technology development, computing is now defining the productivity of the digital economy era. According to The Report, economic growth directly correlates with the development of computing—one point of growth in the computing index translates to a 3.3‰ rise in the size of the digital economy and a 1.8‰ growth in GDP. Specifically, AI computing market share is projected

Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)26.2.2021 11:00:00 EETPress release

Incyte (Nasdaq:INCY) today announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us

WDR expands HD capacity with SES on ASTRA 19.2 degrees East26.2.2021 10:50:00 EETPress release

The leading German public broadcaster Westdeutscher Rundfunk (WDR), regional member of the ARD broadcasting group operating in North Rhine-Westphalia, has expanded its partnership with SES to secure an additional transponder for High Definition (HD) programming on ASTRA 19.2 degrees East orbital position in a multi-year contract. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225006378/en/ WDR expands HD capacity with SES on ASTRA 19.2 degrees East (Photo: Business Wire) Starting 3 March 2021, viewers in the region will be able to receive WDR’s entire programming in HD quality, including the popular "WDR Lokalzeit", a regionally focused program produced by WDR’s numerous local studios. Viewers who do not own an HD-capable television set will continue to receive WDR's programming in SD format until termination of SD transmitting. “Delivering reliable and high-quality free-to-air regional TV news and entertainment content i

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom