GSK gets EU okay for RSV shot in younger age group

GSK has claimed a new approval for its respiratory syncytial virus (RSV) vaccine Arexvy, currently locked in a battle for market share with rival shots from Pfizer and Moderna, that could lend it a competitive advantage.

The European Commission has cleared Arexvy for adults aged 50 through 59 who are at increased risk of lower respiratory tract disease (LRTD) caused by RSV, extending its use beyond the over-60s.

It unlocks a sizeable patient population for the vaccine, as GSK estimates that around 20 million adults aged 50-59 in Europe have a medical condition that increases their risk of RSV disease.

At the moment, Pfizer's Abrysvo and Moderna's mResvia – currently the only other approved RSV vaccines in the EU for older adults – are only approved for the over-60 age bracket, so Arexvy has been given a boost just ahead of this year's RSV season.

Pfizer's jab, meanwhile, is the only one of the three labelled for use as a maternal vaccine to prevent RSV in newborns and infants, although that is a much smaller market.

The EU follows the US in approving the use of the shot in the younger age range in people with conditions like chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes. LRTD caused by RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.

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

Regulatory approval is only the first stage in widening access to Arexvy, however, as national immunisation technical advisory groups (NITAGs) in the EU will still need to recommend the use of the vaccine in this lower age group.

Earlier this year, there was a worrying development for all the RSV vaccine developers after the US recommended use only in the over-75s and 60 to 74-year-olds with underlying health conditions in 2024/25, a narrower group than in the previous season.

Arexvy is top of the list of GSK's recent product launches in terms of importance and is currently out in front in the market, having made around $1.6 billion in sales last year, compared to $890 million for Abrysvo.

In the first half of this year – out of the peak immunisation period – sales of the two shots were $322 million and $201 million, respectively. Moderna's mResvia was approved too late in the period to register sales but will be in the mix for the coming season.

GSK, Pfizer, and Moderna are also running trials in adults aged over 18 to try to broaden the labels of their RSV vaccines.