RCS - Moderna Inc - Moderna Submits Filing to EMA for COVID-19 Vaccine

ModernaAnnouncement

03/07/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230703:nRSC6486Ea&default-theme=true

RNS Number : 6486E  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 (https://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.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAUUSRROSUBRAR