GSK gets European approval for RSV vaccine

Pharmaceuticals giant GSK announced on Wednesday that the European Commission has granted authorisation for ‘Arexvy’ - an adjuvant respiratory syncytial virus (RSV) vaccine - for active immunisation to prevent RSV-caused lower respiratory tract disease (LRTD) in adults 60 and older.

This company said it was the first time an RSV vaccine for older adults had received European marketing approval, adding that it was scheduled to launch ahead of the upcoming 2023-2024 RSV season, which typically starts in the autumn.

It described RSV as a highly contagious respiratory virus that poses a considerable health risk to adults aged 60 and above, resulting in more than 270,000 hospitalisations and around 20,000 in-hospital deaths each year in Europe.

The number of people in the age group affected by RSV acute respiratory infection (ARI) is estimated to be around three million annually, and as the population aged, the impact on healthcare systems was expected to grow.

People with underlying medical conditions such as diabetes and chronic heart and lung disease account for the majority of RSV hospitalisations.

GSK said its successful pivotal ‘AReSVi-006’ phase three trial data formed the basis for the authorisation, which demonstrated that the vaccine had a statistically significant and clinically meaningful overall efficacy of 82.6% against RSV LRTD in adults aged 60 and above, meeting the primary endpoint.

Additionally, the vaccine showed an efficacy of 94.6% in older adults with at least one underlying medical condition, including certain cardiorespiratory and endocrine-metabolic conditions.

The vaccine was generally well tolerated, with the most commonly observed solicited adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia.

Those adverse events were mostly mild to moderate in severity, and of short duration, GSK explained.

It said the decision by the European Commission followed the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in April.

GSK's marketing authorisation application was subjected to an accelerated assessment mechanism due to the recognition of the prevention of RSV disease in the older adult population as a major public health priority.

Already approved by the US Food and Drug Administration (FDA) in May, Arexvy became the world's first RSV vaccine authorised for older adults.

Later in June, the Advisory Committee on Immunization Practices (ACIP) in the US will make recommendations on the appropriate use of the vaccine, while regulatory reviews were also underway in Japan and a number of other countries.

“Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year,” said chief scientific officer Tony Wood.

“This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK's long history of vaccine innovation.

“Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.”

Reporting by Josh White for Sharecast.com.