Source – Moderna
On July 5, 2023 Moderna, a biotech company at the forefront of mRNA vaccines, shared an update on their regulatory progress for mRNA-1345, a vaccine designed to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years and above.
“We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the US RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions. Our mRNA platform has allowed us to move from initial clinical testing to our first international Phase III trial to initiation of regulatory submissions for mRNA-1345 in just two years, enabling us to tackle this pervasive public health burden with speed and clinical rigor. mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in the future – further demonstrating the tremendous potential of mRNA to combat disease.”
– Stéphane Bancel, Chief Executive Officer of Moderna
The company has submitted applications for marketing authorization of mRNA-1345 to the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia. Additionally, they have initiated the rolling submission process for a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) to obtain a license for the mRNA-based RSV vaccine.
These regulatory submissions are supported by positive data from the pivotal ConquerRSV study. This study involved approximately 37,000 adults aged 60 years or older from 22 countries. It was a randomized, double-blind, placebo-controlled trial. The primary efficacy endpoints were based on two different definitions of RSV-LRTD: the presence of either two or more symptoms, or three or more symptoms of the disease. The trial successfully achieved both primary efficacy endpoints, demonstrating a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. The vaccine was well tolerated with a favorable safety profile. Most of the reported adverse reactions were mild or moderate, and the commonly reported reactions in the mRNA-1345 group were pain at the injection site, fatigue, headache, muscle pain, and joint pain. The ConquerRSV study is still ongoing, with plans for further efficacy analyses as more cases accrue, including severe RSV cases. Furthermore, mRNA-1345 is also being investigated in a Phase I trial involving pediatric populations, which is fully enrolled.
In January 2023, the US FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults aged 60 years or older. Prior to that, in August 2021, mRNA-1345 received Fast Track designation from the US FDA. In Australia, the TGA submission will be evaluated through the Priority Pathway, following the approval of the Priority Determination application for mRNA-1345 in April 2023.
Moderna’s respiratory disease vaccine pipeline includes Phase III trials for influenza and a next-generation COVID-19 candidate. The pipeline also encompasses four additional influenza vaccines with expanded antigens, vaccines targeting other respiratory pathogens, and five combination vaccine programs.
