Moderna Applies for Approval of RSV Prevention Vaccine to Regulatory Agencies Worldwide

Messenger ribonucleic acid (mRNA) therapeutics and vaccine company Moderna announced on the 5th (local time) that it has submitted a marketing authorization application for 'mRNA-1345,' a vaccine developed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 and over, to the European Medicines Agency (EMA), Swissmedic, and the Australian Therapeutic Goods Administration (TGA), and has also initiated the Biologics License Application (BLA) process with the U.S. Food and Drug Administration (FDA).

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Stefan Bancel, CEO of Moderna, stated, “We are proud to submit the authorization applications for Moderna’s RSV vaccine candidate mRNA-1345 to the European Union (EU), Switzerland, Australia, and the United States. RSV is a major cause of lower respiratory tract infections in older adults, and hospitalizations and emergency room visits due to RSV can increase the burden on healthcare systems.” He added, “mRNA-1345 is the second product developed on Moderna’s mRNA platform awaiting global approval. Based on recently released positive data on rare diseases and cancer, we believe we can continue to demonstrate the limitless potential of mRNA technology.”

This authorization application is based on positive interim analysis data from the randomized, double-blind, placebo-controlled clinical trial 'ConquerRSV,' conducted in approximately 37,000 adults aged 60 and older across 22 countries. The primary endpoints of ConquerRSV were set based on two definitions of RSV lower respiratory tract disease, defined by the presence of two or more symptoms or three or more symptoms. The trial demonstrated a vaccine efficacy (VE) of 83.7% against RSV lower respiratory tract disease defined by two or more symptoms and 82.4% efficacy against RSV lower respiratory tract disease defined by three or more symptoms, meeting both primary endpoints.

The safety profile and tolerability were also confirmed to be favorable. Most reported adverse events were mild or moderate in severity. The most commonly reported side effects were injection site pain, fatigue, headache, muscle pain, and joint pain. The trial is ongoing, and additional efficacy analyses, including on severe RSV cases, are planned as infection cases accumulate. In addition to older adults, a Phase 1 clinical trial targeting pediatric populations is also underway for mRNA-1345.

mRNA-1345 was designated as a Fast Track product in August 2021 and was also designated as a Breakthrough Therapy by the FDA in January of this year. The approval application submitted to the Australian TGA is expected to receive priority review following the acceptance of the priority review scheme application for mRNA-1345 submitted in April.