RCS - Moderna Inc - Moderna Achieves Positive Interim Results in Trial

ModernaAnnouncement

26/03/2024 11:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240326:nRSZ2503Ia&default-theme=true

RNS Number : 2503I  Moderna Inc  26 March 2024

Moderna Achieves Positive Interim Results from Phase 3 Trial of
Next-Generation COVID-19 Vaccine

·      mRNA-1283 induced a more robust immune response compared to
Spikevax(®) COVID-19 vaccine, mRNA-1273.222

·      Next-generation mRNA vaccine design offers the potential of
longer shelf life and storage advantages, and paves the way for combination
vaccine against influenza and COVID-19, mRNA-1083

CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA)
today announced that mRNA-1283, the Company's next-generation COVID-19
vaccine, has successfully met the primary endpoints of its Phase 3 clinical
trial, demonstrating a higher immune response against SARS-CoV-2 when compared
to mRNA-1273.222, Moderna's licensed COVID-19 vaccine.

"We are excited to announce our fourth infectious disease vaccine program with
positive Phase 3 data, further validating our robust mRNA platform," said
Stéphane Bancel, Chief Executive Officer of Moderna. "mRNA-1283 is a critical
component of our combination vaccine against flu and COVID-19, mRNA-1083, and
this milestone gives us confidence in our ability to bring this much needed
vaccine to market."

In the NextCOVE (NCT05815498) Phase 3 pivotal trial, mRNA-1283 was shown to
elicit a higher immune response against both the Omicron BA.4/BA.5 and
original virus strains of SARS-CoV-2, compared to mRNA-1273.222. Importantly,
this benefit was most acutely seen in participants over the age of 65 years,
the population that remains at highest risk for severe outcomes from COVID-19.
The most common solicited local adverse event was injection site pain. The
most common solicited systemic adverse events included headache, fatigue,
myalgia and chills.

The NEXTCove clinical trial (https://pr.report/3-xOfhQo) is a randomized,
observer-blind, active-controlled study of approximately 11,400 individuals
aged 12 years and older in the United States, United Kingdom and Canada.
mRNA-1283 was found to have a similar safety profile to Moderna's approved
COVID-19 vaccines.

The storage, shelf life and pre-filled syringe presentation of mRNA-1283 could
alleviate healthcare provider burden and potentially increase access into new
settings to serve public health. A detailed analysis of the Phase 3 clinical
trial data for mRNA-1283 will be shared at the Company's Vaccines Day event on
March 27 and presented at upcoming scientific conferences.

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
(https://pr.report/UJcAC0bn) and connect with us on X (formerly Twitter),
Facebook, Instagram, YouTube and LinkedIn.

Spikevax(®) is a registered trademark of 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 longer refrigerator shelf life and storage
advantages of mRNA-1283 compared to Spikevax; and the ability of mRNA-1283 to
maintain effectiveness compared to Spikevax. 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, 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/FTNu3fpZ) .
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:

Elise Meyer

Sr. Director, Corporate Communications

+1 617-852-7041
Elise.Meyer@modernatx.com (mailto:Elise.Meyer@modernatx.com)

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

+1 617-209-5834
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  NRAUNSRRSBUOURR