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
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 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. 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
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.