WASHINGTON (dpa-AFX) - Moderna, Inc. (MRNA) announced Friday that the
European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion recommending the granting of marketing
authorization in the European Union for mRESVIA (mRNA-1345) to protect adults
aged 60 years and older from lower respiratory tract disease caused by RSV
infection.

Following the CHMP's positive opinion, the European Commission will adopt a
decision on the authorization of mRESVIA, an mRNA respiratory syncytial virus
(RSV) vaccine.

RSV is a highly contagious seasonal respiratory virus and a leading cause of
lower respiratory tract infections and pneumonia.

The CHMP positive opinion for mRESVIA is based on positive data from the Phase 3
clinical trial ConquerRSV, a global study conducted in approximately 37,000
adults ages 60 years or older in 22 countries.

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA
(mRNA-1345) to protect adults aged 60 years and older from lower respiratory
tract disease caused by RSV infection.



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