Moderna, Inc.
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.
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
MicroVision To Announce Fourth Quarter and Full Year 2024 Results on March 26, 202512.3.2025 16:05:00 CET | Press release
REDMOND, WA / ACCESS Newswire / March 12, 2025 / MicroVision, Inc. (NASDAQ:MVIS), a technology pioneer delivering advanced perception solutions in autonomy and mobility, today announces that it will report its fourth quarter and full year 2024 financial results on Wednesday, March 26, 2025 after the market close. The Company will subsequently hold a conference call and webcast, consisting of prepared remarks by management, a slide presentation, and a question-and-answer session at 1:30 PM PT/4:30 PM ET on Wednesday, March 26, 2025 to discuss the financial results and provide a business update. Analysts and investors may pose questions for management during the live webcast on March 26, 2025, and may submit questions HERE in advance of the conference call. The live webcast and slide presentation can be accessed on the Company's Investor Relations website under the Events tab HERE. The webcast will be archived on the website for future viewing. About MicroVision MicroVision drives global
Curve Energy Corp. And Lot 49 Capital Corp. Sign Definitive Agreement for Amalgamation and TSX Venture Listing11.3.2025 18:35:00 CET | Press release
VANCOUVER, BC / ACCESS Newswire / March 11, 2025 / Curve Energy Corp. (the "Company" or "Curve") and Lot 49 Capital Corp. ("Lot 49") are pleased to announce that they have entered into a definitive agreement (the "Definitive Agreement") to combine the two companies (the "Transaction") which will constitute a reverse takeover transaction ("RTO") of Lot 49. The Transaction is structured to facilitate the listing of the combined entity on the TSX Venture Exchange ("TSXV"). The Transaction is expected to be completed by way of a three-cornered amalgamation under the provisions of the Business Corporations Act (British Columbia) whereby a wholly-owned subsidiary of Lot 49 ("SubCo"), will amalgamate with Curve. All of the issued and outstanding common shares of SubCo and Curve following the amalgamation will be immediately exchanged for common shares of Lot 49 ("Lot 49 Shares") on a one-for-one basis. In connection with closing of the Transaction, Lot 49 intends to settle approximately $138,
Bear Robotics' Carti 100 Wins iF DESIGN AWARD 2025, Setting New Standards in Logistics Automation11.3.2025 11:58:00 CET | Press release
REDWOOD CITY, CA / ACCESS Newswire / March 11, 2025 / Bear Robotics is thrilled to announce that its Carti 100 autonomous mobile robot has been awarded the prestigious iF DESIGN AWARD 2025 in the Product category, Robotics discipline. This achievement reinforces Bear Robotics' position as a leader in innovative robotic design for logistics, building upon the success of the Servi Plus award earlier last year. Carti 100 stood out among nearly 11,000 entries from 66 countries, impressing a panel of 131 international design experts. The iF DESIGN AWARD, recognized globally as a symbol of design excellence, underscores Bear Robotics' commitment to merging cutting-edge technology with user-centric design. Designed by Bear Robotics' in-house design and engineering teams in Silicon Valley, Carti 100 is engineered to revolutionize indoor logistics. Capable of carrying loads up to 220 lbs, and offering extensive customization options, Carti 100 integrates seamlessly into diverse operational envi
Formerra Introduces Formerra+ Upgraded Ecommerce Site to Optimize Customer Experience11.3.2025 09:15:00 CET | Press release
Formerra+™ delivers a faster, smarter, and more seamless way to do business with enhanced product search, intuitive navigation, and powerful management tools. ROMEOVILLE, IL / ACCESS Newswire / March 11, 2025 / Formerra, a leader in performance materials distribution, today launched the Formerra+ ecommerce website, now upgraded to deliver a faster, more intuitive, and personalized experience for customers across multiple industries. The enhanced site provides purchasing, engineering, and quality control customers with easy access to ordering and technical information so that they can get the materials they need faster. "Our customers are looking for efficiency, accuracy, and convenience when managing orders and purchasing materials," said Cathy Dodd, Chief Executive Officer at Formerra. "The upgraded Formerra+ online and mobile experience reflects our commitment to delivering the best digital tools and 24/7 ordering experience to customers worldwide." Formerra+ offers simplified naviga
135 Years of Sport Inspiration: U.S. Polo Assn. Hosts Celebration Cup Exhibition and Spring-Summer 2025 Fashion Showcase in Delhi11.3.2025 07:00:00 CET | Press release
WEST PALM BEACH, FL AND NEW DELHI, INDIA / ACCESS Newswire / March 11, 2025 / U.S. Polo Assn. celebrates 135 years of sport inspiration as the official brand of the United States Polo Association (USPA) with a spectacular exhibition game and fashion show in the heart of India's polo capital, Delhi. More than 300 VIP guests attended this milestone event honoring the sport's enduring legacy with a thrilling exhibition match at the iconic Jaipur Polo Grounds, followed by an exclusive U.S. Polo Assn. Spring-Summer 2025 fashion showcase at the luxurious D'Monde Members Club.U.S. Polo Assn. As part of U.S. Polo Assn.'s global moment, this grand event united polo enthusiasts, fashion aficionados, and cultural tastemakers in an event that paid tribute to the sport's rich heritage and longstanding influence. The highlight of the evening was an intense and action-packed exhibition match, where the USPA India Team, led by HH Maharaja Sawai Padmanabh Singh of Jaipur, took on the USPA Global Team w
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom