European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against
November 17, 2020
Rolling review accepted by EMA based on preclinical, clinical and CMC data available to date
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 17, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA
(mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the European
Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of mRNA-1273, the Company’s vaccine candidate against
COVID-19, following the confirmation of eligibility of mRNA-1273 for submission on October 14, 2020.
Yesterday, Moderna announced that the independent, U.S. NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of
mRNA-1273 has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of
94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the
National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health
and Human Services.
“The start of the rolling review process marks an important next step as we continue to advance mRNA-1273 in collaboration with European regulatory
authorities,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will continue our ongoing dialogue with the EMA as we seek to develop a
safe and effective vaccine. We are also scaling up global manufacturing with our strategic partners Lonza of Switzerland, and ROVI of Spain to be able
to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”
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 and cardiovascular 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 five years. To learn more, visit www.modernatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including statements regarding: the Company’s plans to submit an application for approval to the EMA for mRNA-1273; the potential for mRNA-1273
to be marketed in EU member states and other countries; mRNA-1273's efficacy and its ability to prevent infection or mitigate symptoms of COVID-19;
plans for the manufacture of mRNA-1273 and the scale of anticipated production; and the Company’s development of mRNA-based medicines and
therapies. 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: preclinical and clinical
development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development
candidates may be delayed, terminated, or may never advance to or in the clinic; no commercial product using mRNA technology has been approved
and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented
nature of this new class of medicines; despite having ongoing interactions with the FDA, EMA or other regulatory agencies, the FDA, EMA 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; the fact that the rapid response technology in use by Moderna is still being developed
and implemented; potential adverse impacts due to the global COVID-19 pandemic such as delays in clinical trials, preclinical work, overall operations,
regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and
those 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.
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Director, Corporate Communications
Head of Investor Relations