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On Thursday, GSK (LSE:GSK) announced that the European Commission has approved its respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 50 to 59 who are at increased risk of severe RSV-related illness. This approval marks the first time a vaccine has been authorized in Europe to protect this age group from lower respiratory tract disease (LRTD) caused by RSV.
The FTSE 100 pharmaceutical company highlighted the significance of this expanded indication, noting that approximately 20 million adults in the 50 to 59 age bracket across 30 European countries have underlying health conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, or diabetes. These conditions heighten their susceptibility to severe outcomes from RSV.
The European Commission's decision follows earlier approvals for Arexvy's use in adults aged 60 and over in Europe and a similar authorization in the United States. GSK has also filed for regulatory approval in Japan and other regions to extend the vaccine's use further.
The approval was supported by positive phase three trial results, which demonstrated the vaccine's safety and efficacy in adults aged 50 to 59, including those with existing medical conditions. Additional trials are ongoing to assess the vaccine's effectiveness in younger adults and immunocompromised individuals, with results anticipated later in the year.
Tony Wood, GSK's Chief Scientific Officer, commented on the approval, emphasizing the importance of extending RSV immunization to adults in the 50 to 59 age group. Wood pointed out that RSV infection can significantly impact the health of older adults, especially those with certain medical conditions, thereby placing additional strain on healthcare systems. He expressed satisfaction in being the first to offer a vaccine that helps protect a broader population in Europe from RSV-LRTD.
Following the announcement, GSK shares experienced a slight increase, rising by 0.58% to 1,661p at 0834 BST. The approval underscores GSK's commitment to addressing significant health challenges and advancing public health through innovative solutions.