Arexvy has become the first FDA approved vaccine to treat respiratory syncytial virus (RSV) and will be produced across GlaxoSmithKline’s European and US manufacturing network.

The US Food and Drug Administration (FDA) approved Arexvy last week, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

“Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant,” a spokesperson told BioProcess Insider.

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“Arexvy will have two vials (one antigen and one adjuvant). The healthcare professional will reconstitute these upon administration. This is a similar process to Shingrix which is widely used in a retail setting, meaning pharmacists and healthcare professionals are familiar with this sort of presentation.”

RSV is a contagious virus affecting the lungs and breathing passages, which causes the hospitalization of approximately 177,000 adults 65 years and older each year in the US. Arexvy is approved in individuals 60 years of age and older, but GSK hopes to bring the vaccine to a wider population.

“A clinical trial that aims to expand the population who may benefit from RSV vaccination into adults aged 50-59, including participants with underlying comorbidities, is fully recruited. Results are expected in 2023, together with additional results from the AReSVi-006 phase III efficacy trial and the AReSVi-004 immunogenicity trial.”

With the only approved RSV vaccine so far – Pfizer and Moderna both have RSV vaccines in late-stage trials – GSK told us it is confident in its ability to feed the high demand. In the past, GSK has suffered from too little capacity in its vaccine network, specifically for shingles vaccine Shingrix, which is only now catching up with global demand.

“We have invested significantly in manufacturing capacity to be ready to deliver against the market leader ambition we have for this vaccine candidate, and, based on current estimates of supply and demand, we expect to be able to meet anticipated demand.”

According to the spokesperson, different activities for producing Arexvy will be managed across several of GSK’s manufacturing sites in Europe and the US, with antigen production taking place in Belgium.

“Specifically in the US, packaging activities are done from our site in Marietta (Pennsylvania). Our Hamilton site in Montana plays a key role in adjuvant production.”