Moderna Inc Moderna Submits Filing to EMA for COVID-19 Vaccine
July 03 2023 - 2:00AM
RNS Non-Regulatory
TIDM0A45
Moderna Inc
03 July 2023
Moderna Submits Regulatory Application to the European Medicines
Agency for Its Updated COVID-19 Vaccine
The filing follows the recommendation from regulators and global
public health bodies to develop monovalent XBB.1.5 COVID-19
vaccines
Pending approval, Moderna's updated COVID-19 vaccine will be
available for fall vaccination with ample and timely supply
Preliminary clinical data show that the company's XBB1.5
monovalent vaccine induces an immune response against viruses of
the XBB lineage
CAMBRIDGE, MA / ACCESSWIRE / July 3, 2023 / Moderna, Inc.
(NASDAQ:MRNA), a biotechnology company pioneering messenger RNA
(mRNA) therapeutics and vaccines, today announced that it has
submitted a regulatory application to the European Medicines Agency
(EMA) for its updated COVID-19 vaccine encoding the spike protein
for the XBB.1.5 sublineage of SARS-CoV-2.
"We are proud to announce this filing for our updated COVID-19
vaccine and continue to support the European Union in protecting
citizens against COVID-19," said Stéphane Bancel, Chief Executive
Officer of Moderna. "Our preliminary clinical testing showed that
our updated COVID-19 vaccine is effective in generating an immune
response against the current XBB variants of concern, and we
believe it will play a critical role in protecting against severe
disease and hospitalization. We look forward to working with the
EMA to bring our updated vaccine to people across the European
Union."
The application is based on guidance from the European Centre
for Disease Prevention and Control (ECDC) and the EMA, which
recommended that COVID-19 vaccines be updated to a monovalent
XBB.1.5 composition. This aligns with other regulators and global
public health agencies recommending a monovalent XBB.1.5
composition. Additionally, Moderna has generated preliminary
clinical data of its monovalent XBB.1.5 vaccine candidate showing
an immune response against XBB descendent sublineages such as
XBB.1.5, XBB.1.16, and XBB.2.3.2.
Moderna is in the process of submitting data to regulators
worldwide to advance its updated COVID-19 vaccine in time for the
autumn/winter vaccination season and has recently filed with the
U.S. Food & Drug Administration, Health Canada, and other
health authorities.
About Moderna
In over 10 years since its inception, Moderna has transformed
from a research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across seven modalities, a
broad intellectual property portfolio and integrated manufacturing
facilities that allow for rapid clinical and commercial production
at scale. Moderna maintains alliances with a broad range of
domestic and overseas government and commercial collaborators,
which has allowed for the pursuit of both groundbreaking science
and rapid scaling of manufacturing. Most recently, Moderna's
capabilities have come together to allow the authorized use and
approval of one of the earliest and most effective vaccines against
the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases, and auto-immune diseases. Moderna has been named a top
biopharmaceutical employer by Science for the past eight 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 potential authorization
by European Union health officials of an updated COVID-19 vaccine
(mRNA-1273.815); Moderna's ability to deliver its updated COVID-19
vaccine for the fall vaccination season, pending authorization; the
ability of Moderna's updated vaccine to generate an immune response
against XBB variants of concern; Moderna's submission of data to
regulators worldwide; and the potential for mRNA-1273.815 to
protect against severe disease and hospitalization from COVID-19.
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 those other risks and uncertainties described under
the heading "Risk Factors" in Moderna's Annual Report on Form 10-K
for the fiscal year ended December 31, 2022, 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 this press release.
Moderna Contacts
Media:
Luke Mircea-Willats
Sr. Director, International Communications
Luke.mirceawillats@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
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