EMA Committee For Medicinal
Products For Human Use Adopts Positive Opinion Recommending
Marketing Authorization Of Moderna's RSV Vaccine,
mRESVIA(R)
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 the granting
of marketing authorization in the European Union 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. Following the CHMP's positive
opinion, the European Commission will adopt a decision on the
authorization of mRESVIA.
"The positive opinion from the EMA CHMP for mRESVIA highlights
the innovation and adaptability of our mRNA platform," 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 save healthcare professionals time and reduce
administrative errors. With mRESVIA, we continue to make
significant strides in addressing global public health challenges
posed by respiratory diseases, and we look forward to the decision
on an EU-wide marketing authorization from the European
Commission."
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 CHMP positive opinion 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 potential
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
617-209-5834
Lavina.Talukdar@modernatx.com
[1] Osei-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.