Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine
Rhea-AI Summary
Moderna (NASDAQ:MRNA) has received marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for mRESVIA, its RSV vaccine for adults 60 years and older. This marks Moderna's second approved product in the UK.
The vaccine, designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV), will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire. RSV significantly impacts UK elderly adults, causing 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths annually in those 65 and older.
The approval is based on the Phase 3 ConquerRSV trial, which involved approximately 37,000 adults aged 60+ across 22 countries. No serious safety concerns were identified during the trial.
Positive
- Second product approval in UK market expands revenue potential
- Large addressable market: 175,000 annual GP visits and 14,000 hospitalizations in UK
- Manufacturing facility in Oxfordshire ensures local production capability
- Successful Phase 3 trial with 37,000 participants showing positive safety profile
Negative
- Manufacturing facility not yet operational, pending later 2025 launch
- Faces competition in established RSV vaccine market
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mRESVIA® is Moderna's second approved product in the UK
CAMBRIDGE, MA / ACCESS Newswire / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.
"The MHRA's authorization of our RSV vaccine is an important milestone for Moderna's efforts toward respiratory disease preparedness," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our RSV vaccine will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire, which will be fully operational later this year."
RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. In the UK, RSV has an impact on elderly adults and is responsible for 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths in adults 65 years of age and older per year.[i]
"Given the serious consequences of RSV for older people, which can lead to hospitalization and severe outcomes, we are delighted that the MHRA has authorized our RSV vaccine," said Darius Hughes, UK General Manager of Moderna. "With the MHRA decision, mRESVIA becomes Moderna's second approved product in the UK, further demonstrating the role of mRNA vaccines in helping to protect the public from respiratory diseases."
The approval is based on positive data from the Phase 3 clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. No serious safety concerns were identified in the Phase 3 trial.
About mRNA-1345 (Respiratory Syncytial Virus Vaccine)
mRNA-1345 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.
To date, Moderna has received marketing authorizations for its RSV vaccine in the United States, the European Union, Canada, Qatar, the United Arab Emirates, and Taiwan and has submitted regulatory applications in other markets worldwide.
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 vaccine efficacy and safety of mRNA-1345; the potential for mRESVIA to reduce disease burden from RSV; Moderna's expectation that the MITC will be fully operational later this year; and Moderna's regulatory applications worldwide. 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
International Media:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com
UK Media:
Emma Gilgunn-Jones
Director, UK Communications
Emma.gilgunn-jones@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
1. | Fleming, D.M., Taylor, R.J., Lustig, R.L. et al. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis 15, 443 (2015). https://doi.org/10.1186/s12879-015-1218-z |
SOURCE: Moderna, Inc.
View the original press release on ACCESS Newswire