GSK application for expanded use of RSV vaccine in adults aged 18-49 accepted in Japan
GSK plc has announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted the company's regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18-49 at increased risk of severe RSV disease.
Arexvy was the first vaccine approved in Japan for adults aged 60 years and older for the prevention of RSV disease, and for those aged 50 years and older at increased risk for severe RSV disease.
RSV is a common, contagious virus affecting the lungs and breathing passages impacting an estimated 64 million people of all ages globally every year. RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalisation and even death.
This regulatory submission is supported by positive results from phase IIIb trial NCT063894875 which showed a non-inferior immune response in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions, to that observed in adults aged 60 and above. The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in Japan.
Regulatory submissions to expand the indications for the RSV vaccine continue in other geographies including the US and Europe.
Respiratory syncytial virus vaccine, adjuvanted, contains recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.
The MHLW has approved GSK’s RSV vaccine for the prevention of RSV (respiratory syncytial virus) disease for adults aged 60 years and above and adults aged 50 and older who are considered at increased risk of severe RSV disease. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.
