Moderna's mRNA vaccine mRESVIA has been recommended for a marketing authorization in the EU to protect against respiratory syncytial virus in older adults.
The European Medicines Agency Committee for Medicinal Products for Human Use has recommended granting a marketing authorization for the mRNARSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. It is a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults.
The CHMP's decision was based on a phase 2/3 randomized placebo-controlled study that demonstrated the vaccine's effectiveness in preventing lower respiratory tract disease in people older than 60 years. A final decision on whether to grant a marketing authorization for EU countries will be taken by the European Commission.At its June meeting, the CHMP also backed an update to the composition of the mRNA vaccine Comirnaty to target the new SARS-CoV-2 JN.1 variant.
Vaccines Adult Vaccines Drug/Treatment Safety Drug Safety Treatment Safety Drug Development Drug Discovery Drug Pipeline Drug Development Pipeline Drug Legislation Drug Registries Drug Registry Drug Regulation Adult Respiratory Syncytial Virus (RSV) Infection Adult Respiratory Syncytial Virus - RSV Infection Adult Respiratory Syncytial Virus - RSV Adult RSV Infection
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