GSK gets USFDA priority review for RSV older adult vaccine
GSK’s RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.;
London: GSK plc has announced that the US Food and Drug Administration (USFDA) has accepted a Biologics License Application (BLA) and granted Priority Review for its respiratory syncytial virus (RSV) older adult vaccine candidate.
The US FDA grants Priority Review to applications for vaccines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment or prevention of serious conditions when compared to standard applications. A Priority Review designation means the US FDA's goal is to expedite the review of a BLA, reducing the review period by four months. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is 3 May 2023.
"If approved, GSK's RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection," the company claimed.
Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.
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