GSK marketing authorisation application for RSV older adult vaccine accepted by EMA under accelerated assessment
Respiratory Syncytial Virus is a common contagious virus affecting the lungs and breathing passages.
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London: GSK plc has announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate.
MAAs may be eligible for accelerated assessment if the EMA's Committee for Medicinal Products for Human Use decides the product is of major interest for public health and therapeutic innovation. A European regulatory decision is anticipated in Q3 2023. If approved, GSK's RSV older adult vaccine candidate has the potential to be the vaccine available to help protect older adults from RSV lower respiratory tract disease (LRTD).
Read also: GSK RSV vaccine for older adults under Japanese regulator review
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