09:19 AM EDT, 08/23/2024 (MT Newswires) -- Moderna ( MRNA ) said Friday the European Union's executive arm approved its respiratory syncytial virus vaccine, or RSV, for adults aged 60 years and above.

The European Commission granted marketing authorization for the drugmaker's vaccine, called mRESVIA, to help protect against lower respiratory tract disease caused by RSV infection.

"The European Commission's approval of mRESVIA is an important milestone for public health and highlights Moderna's ( MRNA ) mRNA leadership," Chief Executive Stephane Bancel said in a statement. "This approval marks the first time an mRNA vaccine has been approved for a disease beyond COVID-19 in Europe."

The approval is valid in all EU member states, as well as Iceland, Liechtenstein and Norway. The marketing authorization is based on positive data from a phase 3 clinical trial covering about 37,000 adults aged 60 and above, with results showing a roughly 84% efficacy against RSV lower respiratory tract disease, according to the company.

The US Food and Drug Administration approved the vaccine in May under a breakthrough therapy designation. Moderna ( MRNA ) said it has applied for marketing authorizations in multiple global markets for mRESVIA.

Earlier in the month, Moderna ( MRNA ) lowered its full-year product sales guidance for its respiratory business to a range of $3 billion to $3.5 billion from its previous guidance of $4 billion, citing "very low" demand in the EU this year, potential revenue deferrals for certain international sales into 2025 and growing competition in the US.

On Thursday, the FDA approved the supplemental Biologics License Application for Moderna's ( MRNA ) updated Spikevax COVID-19 vaccine for individuals aged 12 years and above. The updated version targets the KP.2 variant of COVID-19.

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