RCS - Moderna Inc - Moderna’s COVID-19 Vaccine SARS-COV-2 Variant JN.1

ModernaAnnouncement

05/09/2024 13:00

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RNS Number : 0942D  Moderna Inc  05 September 2024

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
(https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant)
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
(https://www.ema.europa.eu/en/documents/other/ema-confirms-its-recommendation-update-antigenic-composition-authorised-covid-19-vaccines-2024-2025_en.pdf)
.

 

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 (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.

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