Moderna Therapeutics Inc (NASDAQ:MRNA) has filed a new drug submission for its vaccine aimed at preventing respiratory syncytial virus (RSV) in adults aged 60 and older with Health Canada, according to a report by MarketWatch.
According to the report, the regulatory submission is based on positive data from a prespecified interim analysis of its ConquerRSV study, which included 37,000 adults aged 60 and older across 22 countries.
Moderna in July commenced the application process for regulatory approval of its RSV vaccine mRNA-1345 in the United States, Australia and Europe.
The vaccine was granted Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) status in late January.
This came after a Phase 3 trial involving mRNA-1345 showed it had a vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by two or more symptoms in older adults.
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