Radiocor News

US FDA extends use of GSK Arexvy vaccine to 50-59 year olds

Vaccine currently used for people over 60 (Il Sole 24 Ore Radiocor) - London, 10 Jun - The UK pharmaceutical group GSK said that the US Food and Drug Administration (FDA) has approved Arexvy of its respiratory syncytial virus (RSV) vaccine for the prevention of RSV lower respiratory tract disease in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older.

GSK said that it has filed regulatory submissions to extend the use of the RSV vaccine to adults aged 50-59 at increased risk in Europe, Japan and other geographies with regulatory decisions undergoing review.

Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in the second half of 2024, it added.

RSV is a common contagious virus affecting the lungs and breathing passages. Each year, RSV is estimated to cause approximately 177,000 hospitalisations in adults 65 years and older and 42,000 in adults aged 50-64 years old in the US, according to GSK.

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(RADIOCOR) 10-06-24 10:56:03 (0195) 5 NNNN

 


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