Confirmation underscores Moderna’s commitment
to make its vaccine available in the EU
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 it has received written confirmation from the
European Medicine Agency (EMA) that mRNA-1273, the Company’s
vaccine candidate against COVID-19, is eligible for submission of
an application for a European Union Marketing Authorization under
the Agency’s centralized procedure. Confirmation of eligibility was
given in response to the submission of a letter of intent enabling
Moderna to evaluate the opportunity for submitting a Marketing
Authorization Application (MAA) for mRNA-1273 with the EMA. This
submission follows positive results from a preclinical viral
challenge study and the positive interim analysis of the Phase 1
study of mRNA-1273 in healthy adults (ages 18-55 years) and older
adults (ages 56-70 and 71+) published in the New England Journal of
Medicine.
Moderna appreciates the EMA’s effective response to this serious
public health emergency by establishing a Fast-Track framework,
which includes rapid scientific advice, rolling review, and
accelerated assessment.
“We are pleased with the productive interactions with the
European regulatory authorities at the National level and at the
EMA level to date and we appreciate their valuable guidance and
confidence in Moderna to pursue an MAA submission for approval in
Europe for our COVID-19 vaccine candidate, mRNA-1273. European
partners, investors and citizens have been part of Moderna from the
beginning of the company and have played an important role in
Moderna’s progress,” said Stéphane Bancel, Moderna’s Chief
Executive Officer. “We are committed to developing a safe and
effective vaccine following the guidance of regulatory agencies and
we will continue our ongoing dialogue with the EMA. Moderna is
scaling up global manufacturing to be able to deliver approximately
500 million doses per year and possibly up to 1 billion doses per
year, beginning in 2021.”
In Europe, the Company is working with its strategic
manufacturing partners, Lonza of Switzerland and ROVI of Spain, for
manufacturing and fill-finish outside of the United States. This is
a dedicated supply chain to support Europe and countries other than
the United States that enter into purchase agreements with
Moderna.
The Phase 1 interim analysis showed that mRNA-1273 was generally
well-tolerated across all age groups and induced rapid and strong
immune responses against SARS-CoV-2. In the 18-55 age group,
neutralizing antibody titers were observed in 100% of evaluated
participants and at the 100 µg dose level selected for Phase 3, the
geometric mean titers were above those seen in convalescent sera.
Similarly, mRNA-1273 induced consistently high levels of
pseudovirus neutralization antibody titers in all participants in
the 56-70 and 71+ age groups. In addition, vaccination with
mRNA-1273 elicited Th1-biased CD4 T cell responses in all age
groups.
mRNA-1273 is currently being studied in a Phase 3 randomized,
1:1 placebo-controlled trial of 30,000 participants at the 100 µg
dose level in the U.S. As of Friday, October 9, the Phase 3 COVE
study has enrolled approximately 28,618 participants with more than
22,194 having received their second vaccination. The
clinicaltrials.gov identifier is NCT04470427. For more information
about the Phase 3 COVE study, click here.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines
modality to prevent infectious diseases. Across Moderna’s pipeline,
more than 30,000 healthy volunteers and patients have been enrolled
in Moderna’s clinical studies, including the Phase 3 study of
mRNA-1273. Clinical data demonstrate that Moderna’s proprietary
vaccine technology has been generally well-tolerated and can elicit
durable immune responses to viral antigens. Based on clinical
experience across Phase 1 studies, the company designated
prophylactic vaccines a core modality and is working to accelerate
the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic
vaccines include the ability to combine multiple mRNAs into a
single vaccine, rapid discovery to respond to emerging pandemic
threats and manufacturing agility derived from the platform nature
of mRNA vaccine design and production. Moderna has built a fully
integrated manufacturing plant which enables the promise of the
technology platform.
Moderna currently has seven development candidates in its
prophylactic vaccines modality, including:
Vaccines against respiratory infections
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus (hMPV) and parainfluenza virus type 3
(PIV3) vaccine (mRNA-1653)
- COVID-19 vaccine (mRNA-1273)
- Influenza H7N9 vaccine (mRNA-1851)
Vaccines against infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts
for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya
virus, hMPV/PIV3, CMV, Zika and COVID-19). Moderna’s CMV vaccine is
currently in a Phase 2 dose-confirmation study. Moderna’s
investigational Zika vaccine (mRNA-1893), currently in a Phase 1
study, was granted FDA Fast Track designation in August 2019.
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 the Biomedical Advanced Research and Development
Authority (BARDA), a division of the Office of the Assistant
Secretary for Preparedness and Response (ASPR) within the U.S.
Department of Health and Human Services (HHS). 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 a single marketing application to the EMA for
mRNA-1273; the potential for mRNA-1273 to be marketed in EU member
states and other countries; the potential for mRNA-1273 to induce
rapid and strong immune responses against SARS-CoV-2 in individuals
of different ages; plans for the manufacture of mRNA-1273 and the
scale of anticipated production; and the potential advantages of
mRNA-based prophylactic vaccines and the ability to combine
multiple mRNAs into a single vaccine. 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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version on businesswire.com: https://www.businesswire.com/news/home/20201014005511/en/
Moderna
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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