GSK claims first EU approval for an RSV vaccine

GSK’s Arexvy has become the first vaccine for respiratory syncytial virus (RSV) to be approved in the EU, getting the nod from the European Commission for use in older adults aged 60 or over.

The go-ahead comes a little more than a month after GSK was approved in the US, and keeps GSK marginally ahead of Pfizer, its closest rival in the RSV vaccine race, which got FDA approval for its Abrysvo shot last week.

In a statement, GSK said it expects top be able to launch Arexvy in its first EU markets in time for the 2023/24 RSV vaccine, which typically starts in the autumn. Pfizer filed for approval of Abrysvo in the EU in February, around four months after GSK’s shot, so could struggle to be ready in time for the coming season.

“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,” said Tony Wood, GSK’s chief scientific officer. Launch of Arexvy in the EU will as ever depend on the outcome of member state decisions on access and reimbursement.

RSV leads to over 270,000 hospitalisations and approximately 20,000 in-hospital deaths in the 60-plus age bracket every year in Europe, according to GSK.

GSK’s approval is based on the phase 3 AReSVi-006 study, showed an estimated 83% protection against RSV-confirmed lower respiratory tract infections for at least six months.

There were, however, relatively few of those infections in the study, and the drugmaker has re-randomised subjects for a second season to receive either vaccine or placebo to provide additional data on efficacy and the duration of protection, with results due later this year.

GSK is also building a dataset to try to support use of Arexvy in people aged 50 to 59 who are at higher risk of complications from RSV infection.

Later this month, a Centers for Disease Control and Prevention (CDC) advisory committee will make recommendations on the appropriate use of both GSK and Pfizer vaccines in the US. GSK’s vaccine is also under regulatory review in Japan, where it also expects to be first to market.

The RSV vaccine market has been estimated to be worth somewhere between $5 billion and $10 billion a year worldwide, with analysts giving an edge to GSK’s shot thanks to a higher top-line efficacy in trials.

Both Pfizer and GSK are predicting blockbuster sales of their jabs, although they need to keep an eye on the rear-view mirror, as competing candidates from Moderna and Bavarian Nordic are in late-stage development.