EMA Committee for Medicinal
Products for Human Use Adopts Positive Opinion Recommending
Authorization of Moderna's COVID-19 mRNA
Vaccine Targeting the SARS-COV-2 Variant JN.1
Moderna's updated COVID-19
mRNA vaccine will be available for the 2024-2025 vaccination
season, pending a European Commission authorization
decision
CAMBRIDGE, MA / September 5, 2024 / 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 an updated
formulation of the COVID-19 mRNA vaccine Spikevax, targeting the
SARS-CoV-2 variant JN.1, 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 the autumn/winter season
2024-2025.
"The CHMP's positive recommendation
for our updated COVID-19 mRNA vaccine targeting the SARS-CoV-2
variant JN.1 is a key milestone, demonstrating our commitment to
protecting citizens across the European Union," said Stéphane
Bancel, Chief Executive Officer of Moderna. "As respiratory
diseases increase during the winter months, it is crucial for
people to protect themselves by getting vaccinated with an updated
COVID-19 vaccine that provides enhanced neutralizing antibody
responses to JN.1 and its descendant lineages."
The CHMP decision is based on a
combination of manufacturing and preclinical data, as well as
previous clinical, non-clinical, and real-world evidence supporting
the efficacy and safety of Moderna's COVID-19 mRNA vaccines. The
updated vaccine composition is based on guidance from the
EMA's Emergency Task Force (ETF) in April 2024,
which
recommended that COVID-19 vaccines be
updated to target the JN.1 family of Omicron subvariants
for the 2024-2025 vaccination campaign. The EMA
confirmed this recommendation in
July 2024.
Moderna has received approval for its
COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 in
Japan, Taiwan, and the UK. In the U.S., Moderna has received
approval for its COVID-19 vaccine targeting the KP.2 variant of
SARS-CoV-2. Additional regulatory applications for Moderna's
updated COVID-19 vaccines targeting KP.2 or JN.1 are under review
by other regulatory agencies.
In the European Union, Moderna is
participating in a tendering procedure for mRNA COVID-19 vaccines
by the Health Emergency Preparedness and Response Authority (HERA)
of the European Commission (EC).
About
Moderna
Moderna is a leader in the creation of
the field of mRNA medicine. Through the advancement of mRNA
technology, Moderna is reimagining how medicines are made and
transforming how we treat and prevent disease for everyone. By
working at the intersection of science, technology and health for
more than a decade, the company has developed medicines at
unprecedented speed and efficiency, including one of the earliest
and most effective COVID-19 vaccines.
Moderna's mRNA platform has enabled
the development of therapeutics and vaccines for infectious
diseases, immuno-oncology, rare diseases and autoimmune diseases.
With a unique culture and a global team driven by the Moderna
values and mindsets to responsibly change the future of human
health, Moderna strives to deliver the greatest possible impact to
people through mRNA medicines. For more information about Moderna,
please visit modernatx.com and connect with us on X (formerly
Twitter), Facebook, Instagram, YouTube and LinkedIn.
Moderna 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 potential authorization by the European
Commission of Moderna's updated JN.1-targeting COVID-19 vaccine for
autumn/winter 2024; the availability of Moderna's JN.1-targeting
COVID-19 vaccine; and the ability of Moderna's updated COVID-19
vaccine to induce an immune response against circulating variants
and provide protection for autumn/winter 2024. 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, those 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, 2023 and in subsequent filings
made by Moderna with the U.S. Securities and Exchange Commission,
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.