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Key takeaways:
- Moderna initiated the rolling submission process for its mRNA-1345 RSV vaccine.
- Phase 3 trial data have shown vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Moderna has initiated the rolling submission process for its respiratory syncytial virus vaccine candidate mRNA-1345, the company announced Wednesday.
The company said in a press release that the rolling submission is for a biologics license application to the FDA for the license of its messenger RNA-based RSV vaccine. This would allow the company to submit relevant data as they are collected and for Moderna to begin the process of getting mRNA-1345 approved.
Moderna
“We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345,” Stéphane Bancel, chief executive officer of Moderna, said in a statement. “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.”
According to Moderna, the application is based on positive data from the phase 3 ConquerRSV study, which enrolled approximately 37,000 adults aged 60 years or older from multiple countries to test the vaccine.
The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88%; CI, 66.1%-92.2%) against RSV-associated lower respiratory tract disease defined by two or more symptoms, and a VE of 82.4% (96.36%; CI, 34.8%-95.3%) against RSV-associated lower respiratory tract disease defined by three or more symptoms.
The study also showed that the vaccine was generally safe, with the most common side effects being injection-site pain, fatigue and headache.
Previously, the FDA granted mRNA-1345 breakthrough therapy designation for the prevention of [RSV-associated lower respiratory tract disease] in adults aged 60 years or older in January 2023 and fast track designation by the FDA in August 2021.
Moderna said that in addition to older adults, mRNA-1345 is being investigated in a fully enrolled and ongoing phase 1 trial in pediatric populations.
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