GSK;s RSV vaccine gets expanded approval in Europe

(Sharecast News) - GSK announced on Thursday that the European Commission had granted approval for Arexvy, a respiratory syncytial virus (RSV) vaccine, to be used in adults aged 50 to 59 who were at heightened risk of severe RSV-related illness. The FTSE 100 pharmaceuticals giant said the expanded indication was the first time a vaccine had been authorised in Europe to protect the age group from lower respiratory tract disease (LRTD) caused by RSV.

It said the approval was particularly significant given that around 20 million adults in the 50 to 59 age bracket across 30 European countries had underlying health conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, or diabetes, increasing their vulnerability to severe outcomes from RSV.

The decision by the European Commission followed earlier approvals for the vaccine's use in adults aged 60 and over in Europe and a similar authorisation in the United States.

GSK said it had also submitted regulatory filings in Japan and other regions to extend the vaccine's use.

The European Commission's approval was supported by positive phase three trial results, demonstrating the vaccine's safety and efficacy in adults aged 50 to 59, including those with underlying medical conditions.

Further trials were underway to evaluate the vaccine's effectiveness in younger adults and immunocompromised individuals, with results expected later in the year.

"Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50 to 59 who are at increased risk," said GSK chief scientific officer Tony Wood.

"RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems.

"As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD."

At 0834 BST, shares in GSK were up 0.58% at 1,661p.

Reporting by Josh White for Sharecast.com.