Moderna Receives Approval for RSV Vaccine
mRESVIA
CAMBRIDGE, MA /
ACCESSWIRE / August 23, 2024 / Moderna, Inc. (NASDAQ:MRNA)
today announced that the European Commission (EC) has granted
marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory
syncytial virus (RSV) vaccine, to protect adults aged 60 years and
older from lower respiratory tract disease caused by RSV infection.
The marketing authorization follows the Positive Opinion from the
European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP). The authorization is valid in all 27 EU
member states, as well as Iceland, Liechtenstein and Norway.
"The European Commission's approval of mRESVIA is an
important milestone for public health and highlights Moderna's mRNA
leadership. This approval marks the first time an mRNA vaccine has
been approved for a disease beyond COVID-19 in Europe," said
Stéphane Bancel, Chief Executive Officer of Moderna. "mRESVIA
safeguards older adults against severe RSV outcomes and is uniquely
offered in a pre-filled syringe to enhance ease of administration,
which can reduce vaccine preparation time and administrative
errors."
RSV is a highly contagious seasonal respiratory virus
and a leading cause of lower respiratory tract infections and
pneumonia. It causes a particularly high burden of disease in
infants and older adults. In the European Union, RSV is estimated
to cause approximately 160,000 hospital admissions in adults each
year, with 92% of these admissions occurring in adults aged 65 and
over.1
The marketing authorization for mRESVIA is based on
positive data from the Phase 3 clinical trial ConquerRSV, a global
study conducted in approximately 37,000 adults ages 60 years or
older in 22 countries. The primary analysis with 3.7 months of
median follow-up found a vaccine efficacy (VE) against RSV lower
respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%),
with these results published in The New England Journal of Medicine.
In a supplementary analysis with 8.6 months of median follow-up,
mRNA-1345 maintained durable efficacy, with sustained VE of 63.3%
(95% CI: 48.7%, 73.7%) against RSV-LRTD, including two or more
symptoms. VE was 74.6% (95% CI, 50.7, 86.9) against RSV-LRTD with
≥2 symptoms, including shortness of breath, and VE was 63.0% (95%
CI, 37.3%, 78.2%) against RSV LRTD including three or more
symptoms. The stringent statistical criterion of the study, a lower
bound on the 95% CI of >20%, continued to be met for both
endpoints. The most commonly reported solicited adverse reactions
were injection site pain, fatigue, headache, myalgia and
arthralgia.
In May 2024,
the U.S. Food and Drug Administration (FDA) approved mRESVIA
(mRNA-1345) to protect adults aged 60 years and older from lower
respiratory tract disease caused by RSV infection. The approval was
granted under a breakthrough therapy designation and marked
Moderna's second approved mRNA product. Moderna has filed for
mRNA-1345 marketing authorization applications in multiple markets
worldwide.
About
mRESVIA® (Respiratory Syncytial Virus
Vaccine)
mRESVIA® is an RSV vaccine that
consists of an mRNA sequence encoding a stabilized prefusion F
glycoprotein. The F glycoprotein is expressed on the surface of the
virus and is required for infection by helping the virus to enter
host cells. The prefusion conformation of the F protein is a
significant target of potent neutralizing antibodies and is highly
conserved across both RSV-A and RSV-B subtypes. The vaccine uses
the same lipid nanoparticles (LNPs) as the Moderna COVID-19
vaccines.
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.
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
authorization by the European Commission of Moderna's RSV vaccine
mRESVIA; the vaccine efficacy and safety of mRNA-1345; the
potential for mRESVIA to reduce disease burden from RSV; and
Moderna's pending marketing authorization applications for
mRNA-1345. 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
+1 617-209-5834
Lavina.Talukdar@modernatx.com
1Osei-Yeboah R, Spreeuwenberg P, Del Riccio
M, Fischer TK, Egeskov-Cavling AM, Bøås H, van Boven M, Wang X,
Lehtonen T, Bangert M, Campbell H, Paget J; Respiratory Syncytial
Virus Consortium in Europe (RESCEU) Investigators. Estimation of
the Number of Respiratory Syncytial Virus-Associated
Hospitalizations in Adults in the European Union. J Infect Dis.
2023 Nov 28;228(11):1539-1548. doi: 10.1093/infdis/jiad189. PMID:
37246742; PMCID: PMC10681866.
SOURCE: Moderna, Inc.