Moderna Inc EMA Adopts Positive Opinion of Covid-19 Vaccine
14 Setembro 2023 - 11:16AM
RNS Non-Regulatory
TIDM0A45
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 .
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 . 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
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
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