European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
18 November 2020 - 1:18AM
Business Wire
Rolling review accepted by EMA based on
preclinical, clinical and CMC data available to date
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.”
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 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.
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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201117005866/en/
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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