Moderna Initiates Regulatory Application Process Seeking Approval For Its RSV Vaccine In Older Adults
Portfolio Pulse from Vandana Singh
Moderna Inc has initiated the regulatory application process for its mRNA-1345 vaccine to prevent RSV-associated lower respiratory tract disease in adults aged 60 years or older. The company has submitted marketing authorization applications with the European Medicines Agency, Swissmedic in Switzerland, and the Therapeutic Goods Administration in Australia and has initiated the rolling submission process for a Biologics License Application to the FDA. The applications are based on positive data from the ConquerRSV study. The vaccine was well tolerated with a favorable safety profile.
July 05, 2023 | 1:17 pm
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POSITIVE IMPACT
Moderna has initiated the regulatory application process for its mRNA-1345 vaccine. The applications are based on positive data from the ConquerRSV study. The vaccine was well tolerated with a favorable safety profile.
The news of Moderna initiating the regulatory application process for its mRNA-1345 vaccine is directly related to the company and its future prospects. The positive data from the ConquerRSV study and the favorable safety profile of the vaccine could potentially lead to its approval, which would be a significant milestone for the company and could positively impact its stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEUTRAL IMPACT
In May, the FDA approved GSK Plc's Arexvy vaccine in individuals 60 and older, making it the first RSV vaccine for older adults to be approved worldwide.
While GSK's Arexvy vaccine is mentioned in the article, it is in the context of being the first RSV vaccine for older adults to be approved worldwide. This is past news and is unlikely to have a significant impact on GSK's stock price in the short term.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 50