\n\u201cI want to thank Health Canada and the Canadian government for this authorization, which is a significant moment in our company\u2019s history,\u201d said St\u00e9phane Bancel, Chief Executive Officer of Moderna. \u201cHealth Canada provided a comprehensive, thorough review and provided us with ongoing guidance as we worked together to achieve this authorization. I am proud of the role Moderna has been able to play in helping to address this pandemic.\u201d\n<\/p>\n
\nThe authorization comes under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and is based on a rolling review of data that was announced on October 12, 2020. The rolling review includes data from the Phase 3 COVE study involving 30,000 participants.\n<\/p>\n
\nEarlier this month, the Canadian government exercised<\/a> its option to increase its confirmed order commitment by 20 million doses of the Moderna COVID-19 Vaccine against COVID-19, mRNA-1273, bringing its confirmed order commitment to 40 million doses. This increase reflects continued efforts by the Canadian Government to secure access to safe and effective COVID-19 vaccines for Canadian citizens.\n<\/p>\n \nHealth Canada based its authorization on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced<\/a> on November 30. To learn more about Moderna\u2019s work on the Moderna COVID-19 Vaccine, visit www.modernatx.com\/COVID19<\/a>.\n<\/p>\n About the Moderna COVID-19 Vaccine<\/b><\/p>\n \nThe Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized<\/a> form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID\u2019s 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 NIH on February 24, 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, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 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 mRNA-1273. On July 8, the Phase 2 study<\/a> completed enrolment.\n<\/p>\n \nResults 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<\/a> on September 29 in The New England Journal of Medicine<\/i>. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published<\/a> in The New England Journal of Medicine. <\/i>On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published<\/a> in The New England Journal of Medicine<\/i>. On November 30, Moderna announced<\/a> 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) with the European Medicines Agency. On December 3, a letter to the editor<\/a> was published in The<\/i>New England Journal of Medicine <\/i>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.\n<\/p>\n AUTHORIZED USE<\/b><\/p>\n \nModerna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2 vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 18 years of age and older.\n<\/p>\n About Moderna<\/b><\/p>\n \nModerna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body\u2019s 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\u2019s 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.\n<\/p>\n \nHeadquartered 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<\/i> for the past six years. To learn more, visit www.modernatx.com<\/a>.\n<\/p>\n Forward Looking Statements<\/b><\/p>\n \nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company\u2019s development of a vaccine against the novel coronavirus, the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2, and plans for the supply and distribution of the Moderna COVID-19 Vaccine to the Canadian Government. In some cases, forward-looking statements can be identified by terminology such as \u201cwill,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201ccould\u201d, \u201cexpects,\u201d \u201cintends,\u201d \u201cplans,\u201d \u201caims,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cpredicts,\u201d \u201cpotential,\u201d \u201ccontinue,\u201d 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\u2019s 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 mRNA-1273 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\u2019s 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 mRNA-1273; 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 \u201cRisk Factors\u201d in Moderna\u2019s 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\u2019s website at www.sec.gov<\/a>. 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\u2019s current expectations and speak only as of the date hereof.\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201223005397\/en\/<\/a><\/span><\/p>\n Moderna Investors: KEYWORDS:<\/b> Massachusetts United States North America Canada<\/p>\n INDUSTRY KEYWORDS:<\/b> Biotechnology Infectious Diseases Health Pharmaceutical Clinical Trials<\/p>\n<\/p>\n
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Media:
\n<\/b>
Colleen Hussey
\n
Director, Corporate Communications
\n
617-335-1374
\n
Colleen.Hussey@modernatx.com<\/a><\/p>\n
\n<\/b>
Lavina Talukdar
\n
Senior Vice President & Head of Investor Relations
\n
617-209-5834
\n
Lavina.Talukdar@modernatx.com<\/a><\/p>\n
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