EMA approves first RSV vaccine, to be produced in Wallonia

The European Medicines Agency EMA has approved the RSV vaccine Arexvy from British pharmaceutical company GSK. This is the first-ever vaccine against this common respiratory infection and will in part be produced at the company's vaccine plant in Wavre, Wallonia.

The vaccine targets people aged over 60. In Europe, RSV causes about 250,000 hospitalisations and 17,000 deaths in people over 65 every year, according to EMA figures. The approval was accelerated because the EMA believes that combating RSV in the elderly is of great health importance.

The RSV vaccine is produced at GSK's plant in Wavre, Walloon Brabant, among other sites. GSK employs around 9,000 people in Belgium and last year invested 70 million euros in its Wavre site, which is the biggest vaccine factory in the world.

The EMA based its approval on data from a phase 3 study of 25,000 over-60s in 17 countries, which showed an estimated 83 per cent protection against RSV. ​
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​The vaccine is not formally approved by the EU yet. The EMA's conclusions will now be sent to the European Commission, which has the final say. The Commission tends to follow the EMA's guidance, however, and GSK expects formal approval in July.

^{© KENZO TRIBOUILLARD / AFP}