RCS - Moderna Inc - EMA Adopts Positive Opinion of Covid-19 Vaccine

ModernaAnnouncement

14/09/2023 15:30

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230914:nRSN5035Ma&default-theme=true

RNS Number : 5035M  Moderna Inc  14 September 2023

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion
Recommending Authorization of Moderna's Updated Covid-19 Vaccine in The
European Union

The positive opinion follows the recommendation from regulators and global
public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for
autumn/winter 2023 vaccination campaigns

Clinical trial data from research assay confirmed Moderna's updated COVID-19
vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against
circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants

CAMBRIDGE, MA / ACCESSWIRE / September 14, 2023 / Moderna, Inc. (Nasdaq:MRNA)
today announced that the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive opinion
recommending marketing authorization for Spikevax, its updated COVID-19
vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for
active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals
six months of age and older. Following the CHMP's positive opinion, the
European Commission will make an authorization decision on the use of
Moderna's updated COVID-19 vaccine for autumn/winter 2023.

"The CHMP's positive recommendation for our updated COVID-19 vaccine is a key
milestone given we see increasing transmission of SARS-CoV-2 across Europe.
Our updated COVID-19 vaccine generates a strong human immune response against
circulating variants, including BA.2.86, EG.5, and FL.1.5.1, and will be a
critical tool for protection," said Stéphane Bancel, Chief Executive Officer
of Moderna. "We are working with governments across Europe to include our
updated COVID-19 vaccine in national vaccination programs, to ensure a
diversified portfolio that provides vaccine choice and access to single dose
vial formats, which can limit waste."

Moderna has generated clinical data of its monovalent XBB.1.5 vaccine
candidate showing an immune response against XBB sublineages XBB.1.5,
XBB.1.16, and XBB.2.3.2, in addition to BA.2.86, EG.5 and FL.1.5.1 variants.
Public health authorities are vigilantly monitoring the BA.2.86 variant, a
highly mutated strain of COVID-19 with over 30 mutations as compared to prior
Omicron strains, with some governments accelerating COVID-19 vaccination
campaigns due to its potential to break through protective immunity generated
from previous COVID-19 vaccination or infection.

The most common solicited local adverse event for Moderna's updated COVID-19
vaccine was injection site pain. The most common solicited systemic adverse
events include fatigue, headache, myalgia, arthralgia, and chills. Moderna's
updated COVID-19 vaccine's safety profile is consistent with previous Spikevax
formulations.

Moderna has received authorizations for its updated COVID-19 vaccine in the
U.S., Canada, Japan, and Taiwan to date and has submitted regulatory
applications worldwide.

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
(https://pr.report/W62pwLUg) .

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 the European Commission of Moderna's
updated COVID-19 vaccine for autumn/winter 2023; the expectation that the
European Commission's authorization decision will come shortly; the ability of
Moderna's updated COVID-19 vaccine to induce an immune response against
circulating variants of interest and provide protection for autumn/winter
2023; the safety profile of Moderna's updated COVID-19 vaccine; and Moderna's
regulatory application submissions worldwide for its updated COVID-19 vaccine.
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 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://pr.report/GfYyK84n) . 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 of this press
release.

Moderna Contacts

Media:

Luke Mircea-Willats

Senior Director, International Communications
Luke.mirceawillats@modernatx.com (mailto:Luke.mirceawillats@modernatx.com)

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834
Lavina.Talukdar@modernatx.com (mailto: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  NRALIMITMTBBBIJ