Moderna files global marketing submissions for RSV shot
BeritK

COVID-19 vaccine maker Moderna (NASDAQ:MRNA) announced Wednesday that the company sought marketing authorizations for its investigational Respiratory Syncytial Virus (RSV) vaccine, MRNA-1345, in multiple countries, including the U.S.
The Cambridge, Massachusetts-based biotech said it started a rolling submission with the FDA for its Biologics License Application (BLA) for MRNA-1345 and submitted marketing authorization applications for the candidate in the EU, Australia, and Switzerland.

The messenger-RNA-based vaccine is designed to prevent lower respiratory tract disease and acute respiratory disease linked to RSV in adults aged 60 years or older.
"mRNA-1345 represents the second product coming from our mRNA platform to seek global approval," CEO StÃ©phane Bancel said.
The filings are backed by data from the companyâs ongoing pivotal ConquerRSV study for the shot. An interim readout from the global trial indicated that MRNA-1345 led to 82%â83% vaccine efficacy, meeting both its primary efficacy endpoints. 


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