RCS - Moderna Inc - Moderna Receives Approval for RSV Vaccine mRESVIA

ModernaAnnouncement

23/08/2024 12:30

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240823:nRSW6293Ba&default-theme=true

RNS Number : 6293B  Moderna Inc  23 August 2024

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 (https://pr.report/1umc)  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
(https://pr.report/1umd) . 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 (https://pr.report/g0e) , 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
(https://pr.report/1ume)  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 (https://pr.report/XLhRyDNS) . 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

 

(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.

 

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  NRAPJMBTMTBTBII