GlaxoSmithKline (GSK) has reported encouraging preliminary findings from a Phase III trial evaluating the immune response and safety of its respiratory syncytial virus vaccine, Arexvy, in adults aged 50 to 59. The trial also included participants with certain underlying medical conditions that put them at an increased risk of respiratory syncytial virus (RSV) and lower respiratory tract disease (LRTD).
Arexvy is currently approved in the United States for immunizing adults aged 60 and older against RSV-LRTD, and it has received approvals in Europe, Japan, the UK, and Canada.
The trial results demonstrated that Arexvy elicited an immune response in adults aged 50 to 59 with underlying medical conditions that were comparable to the response observed in adults aged 60 and above. This met the trial’s primary co-endpoint. Notably, previous studies had already shown the vaccine’s efficacy in adults aged 60 and older.
The co-primary endpoint was also met for the broader group of adults aged 50 to 59 who participated in the trial. Safety and reactogenicity data aligned with earlier phase III results, with the most common adverse events being mild and transient, including local events such as pain and systemic events like fatigue and headache.
GSK’s Chief Scientific Officer, Tony Wood, emphasized the importance of these results in providing adults aged 50 to 59 at risk of RSV-LRTD with a potential vaccination option, noting the urgent need for innovative solutions to protect this demographic.
Respiratory syncytial virus (RSV) is a highly contagious virus that can lead to severe respiratory illness. It poses a considerable burden on adults who are at an elevated risk due to factors such as age, underlying medical conditions, and immunocompromised status. RSV can exacerbate pre-existing conditions like chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, potentially leading to pneumonia, hospitalization, or death.
The final trial results will be presented at an upcoming medical conference and submitted for peer-reviewed publication. The data will also be shared with the US Food and Drug Administration (FDA) and other regulatory bodies to support potential label expansions for Arexvy.
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