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Moderna (NASDAQ:MRNA) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed mRESVIA, its vaccine targeted at the respiratory syncytial virus (RSV).
Issuing a so-called positive opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for mRESVIA to protect adults aged 60 years and older from developing lower respiratory tract disease caused by RSV.
The CHMP recommendation will next be reviewed by the European Commission (EC) before a final decision on marketing authorization arrives.
“We look forward to the decision on an EU-wide marketing authorization from the European Commission,” said Stéphane Bancel Moderna (MRNA) CEO.
If finalized, mRESVIA, also known as mRNA-1345, will become Moderna’s (MRNA) second messenger-RNA-based product approved in the region after the company’s COVID-19 vaccine, Spikevax.