Moderna has submitted marketing authorization applications for its investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, Swissmedic in Switzerland, and the Therapeutic Goods Administration in Australia and has initiated a rolling submission of a Biologics License Application to the US Food and Drug Administration (FDA).

mRNA-1345 is designed for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in adults aged 60 years or older.

“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,” says Stéphane Bancel, CEO of Moderna, in a release. “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 two years, enabling us to tackle this pervasive public health burden with speed and clinical rigor.”

The regulatory 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 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of disease. 

The trial met both its primary efficacy endpoints, with a vaccine efficacy of 83.7% against RSV-LRTD as defined by two or more symptoms and a vaccine efficacy of 82.4% against RSV-LRTD 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 commonly 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 analyses are planned as cases accrue, including for severe RSV. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing phase 1 trial in pediatric populations.

In January 2023, the FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults aged 60 years or older, and mRNA-1345 was previously granted Fast Track designation by the FDA in August 2021. 

In Australia, the submission will be evaluated under the Priority Pathway, following approval of the Priority Determination application for mRNA-1345 in April 2023.

Moderna’s respiratory disease vaccine pipeline includes phase 3 trials against influenza and a next-generation COVID-19 candidate. The pipeline also includes four additional influenza vaccines with expanded antigens, vaccines against other respiratory pathogens, and five combination vaccine programs.