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Moderna’s mRESVIA Receives the US FDA’s Approval for Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower…
June 13, 2025

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Moderna’s mRESVIA (mRNA-1345) Vaccine Gains the EC’s Approval to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:    The EC’s approval of mRESVIA (mRNA-1345) vaccine to prevent LTRD due to RSV infection among adults was supported by P-III (ConquerRSV) trial in adults (n=37,000; ≥60yrs.) & is valid across EU plus as Iceland, Liechtenstein & Norway  Primary analysis (3.7mos. median follow-up) depicted vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis…
August 23, 2024

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Moderna’s mResvia (mRNA-1345) Gains the CHMP’s Positive Opinion to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:  The CHMP’s positive opinion of mRESVIA to prevent lower respiratory tract disease (LTRD) due to RSV infection based on the P-III (ConquerRSV) study in adults (n=37,000; ≥60yrs.)  Primary analysis (3.7mos. median follow-up) showed vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis (8.6mos. median follow-up) showed sustained VE of 63.3% against RSV-LRTD…
June 28, 2024

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