Moderna Files Regulatory Submissions for mRNA-1345 Vaccine Against RSV Lower Respiratory Tract Disease

Moderna has filed marketing authorization submissions for mRNA-1345, a vaccine for the prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in adults aged 60 years and older.¹

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The company submitted the applications for the vaccine with the European Medicines Agency, Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia. It has also initiated the rolling submission process for a biologics license application to the FDA for the licensure of the vaccine.¹

"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 [United States]. RSV is a major cause of [LRTD] in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions," Stéphane Bancel, CEO of Moderna, said in a statement. "Our mRNA platform has allowed us to move from initial clinical testing to our first international phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just 2 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."¹

The vaccine consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein and uses the same lipid nanoparticles as the Moderna COVID-19 vaccines.²

The applications are based on positive data from the ConquerRSV study (NCT05127434). The study included approximately 37,000 individuals aged 60 years or older in 22 countries. The primary endpoints included the 2 definitions of RSV-LRTD, either as 2 or more symptoms or 3 or more symptoms of the disease.¹

The trial met both the primary efficacy endpoints, with a vaccine efficacy of 83.7% for 2 or more symptoms and 82.4% for 3 or more symptoms.¹ Additionally, the vaccine was well tolerated with a favorable safety profile, with most solicited adverse events (AEs) being mild or moderate in severity. The most commonly reported AEs were injection site pain, fatigue, headache, myalgia, and arthralgia.

The study is currently ongoing, with additional efficacy evaluations planned.¹ The overall rate of severe solicited systemic AEs was 4% with the vaccine and 2.8% with the placebo.²

The vaccine is also being evaluated in a phase 1 trial for pediatric populations.¹

In January 2023, the FDA granted the vaccine breakthrough therapy designation for the prevention of RSV-LRTD in adults aged 60 years or older and was previously granted fast track designation in 2021.¹

The TGA submission will be evaluated under priority pathway, following approval of the priority determination application for mRNA-1345 in April 2023.¹

Reference

1. Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345. News release. Moderna. July 5, 2023. Accessed July 5, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Global-Regulatory-Submissions-For-Its-Respiratory-Syncytial-Virus-RSV-Vaccine-MRNA-1345/default.aspx
2. Antrim A. FDA grants breakthrough therapy designation to Moderna for investigational RSV vaccine. Pharmacy Times. February 2, 2023. Accessed July 5, 2023. https://www.pharmacytimes.com/view/fda-grants-breakthrough-therapy-designation-to-moderna-for-investigational-rsv-vaccine