Cambridge, July 5, 2023.
It has also initiated the submission of a biologic license application for mRNA-1345 with the US Food and Drug Administration (FDA). mRNA-1345 met the primary efficacy endpoints, demonstrating 83.7% vaccine efficacy against RSV lower respiratory tract disease in older adults in the pivotal Phase 3 efficacy trial, ConquerRSV
Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) vaccines and therapeutics, today provided an update on regulatory submissions for mRNA-1345, a vaccine for the prevention of lower tract disease. RSV-associated lower respiratory disease (RSV-LRTD) and acute respiratory disease (ARD) in adults 60 years of age and older. The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland and the Therapeutic Goods Administration (TGA) in Australia, and has begun the process of submitting a Biological License Application (BLA) to the US Food and Drug Administration (FDA) for vaccine authorization mRNA-based RSV vaccine." We are proud to announce these applications for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the USA. RSV is one of the leading causes of lower respiratory tract infections in older adults and can place a significant burden on healthcare systems through hospitalizations and emergency room admissions," said Stéphane Bancel, CEO of Moderna. "Our mRNA platform has allowed us to go from initial clinical testing to our first international Phase 3 trial to the start of regulatory submissions for mRNA-1345 in just two years, allowing us to address this widespread public health burden with speed and clinical rigor mRNA-1345 represents the second product from our mRNA platform seeking global approval, and with recent positive data in rare diseases and cancer, we look forward to more to come - further demonstrating the tremendous potential of mRNA to combat disease." The authorization applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults aged 60 years and older in 22 countries. Primary efficacy endpoints were based on two definitions of ERV-LRTD, defined as two or more symptoms or three or more symptoms of disease. The trial met its two primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) vs. ESRD due to RSV defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) vs. ESRD due to RSV defined by three or more symptoms. The vaccine was well tolerated with a favorable safety profile. Most solicited adverse reactions were mild or moderate, and the most frequently reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. The ConquerRSV study is ongoing, and additional efficacy analyzes are anticipated as cases accumulate, including for severe RSV. In addition to older adults, mRNA-1345 is being investigated in an ongoing Phase 1 trial with all participants in pediatric populations. In January 2023, the US FDA granted mRNA-1345 therapy designation for the prevention of RSV-LRTD in adults 60 years and older, and mRNA-1345 was previously granted fast track designation by the US FDA in August 2021. In Australia, TGA submission will be evaluated under the Priority Track, following approval of the Priority Determination application for mRNA-1345 in April 2023. Moderna's respiratory vaccine portfolio includes Phase 3 trials against influenza and a new COVID-19 candidate. generation. The pipeline also includes four other expanded antigen influenza vaccines, vaccines against other respiratory pathogens, and five combination vaccine programs. About mRNA-1345 mRNA-1345 is an investigational RSV vaccine consisting of a single sequence of mRNA encoding a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in Moderna COVID-19 vaccines. The F glycoprotein is found on the surface of the virus and is required for infection as it helps the virus to enter host cells. It exists in two states, pre-fusion and post-fusion. The prefusion conformation is an important target of potent neutralizing antibodies, and the protein sequences are largely similar in the RSV-A and RSV-B subtypes.
Contact Contact name: Luke Mircea-Willats Contact description: Senior Director, International Communications