The EC authorisation follows the positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April this year, and the US FDA approval granted last month
GSK scientist holding lab syringe. (Credit: GSK plc.)
GSK has received the European Commission (EC) approval for Arexvy, its adjuvanted respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults, aged 60 years and above.
Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3), combined with the company’s unique AS01E adjuvant.
The EC authorisation follows the positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April this year.
Arexvy was the world’s first RSV vaccine to be approved for older adults, with the US Food and Drug Administration (FDA) approval granted last month, said the company.
The European regulator reviewed the company’s marketing authorisation application under its accelerated assessment mechanism, considering it a significant public health interest.
GSK plans to start commercialising the vaccine prior to the 2023-2024 RSV season.
GSK chief scientific officer Tony Wood said: “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.”
The EC authorisation is supported by positive data from AReSVi-006, the company’s randomised, placebo-controlled, observer-blind, multi-country Phase 3 clinical trial.
The Phase 3 trial enrolled around 25,000 participants from 17 countries, to evaluate the efficacy of a single dose adjuvanted RSVPreF3 vaccine in adults aged 60 years and above.
In the trial, the vaccine showed a statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD, which is the primary endpoint.
In addition, the vaccine showed an overall efficacy of 94.6% in older adults with at least one underlying medical condition of interest.
The vaccine was generally well tolerated, with most frequently observed solicited adverse events including injection site pain, fatigue, myalgia, headache, and arthralgia.
University of Ferrara respiratory medicine head, professor Alberto Papi said: “For most, RSV causes cold-like symptoms. For older adults and those with underlying medical conditions, however, it can lead to severe disease and is a leading cause of serious respiratory infections.
“As scientists, we have been trying to find a solution for over 60 years. I am proud to have been part of the innovation that has resulted in a vaccine now being available to help protect eligible older adults across Europe from severe RSV disease for the first time.”