GSK on Wednesday announced that the European Commission has approved GSK’s respiratory syncytial virus (RSV) vaccine for older adults. This will make it the first shot in the region against the common respiratory disease that can be fatal for seniors.
The move is the final step to allowing the vaccine’s use across the European Union, after the European Medicines Agency (EMA) recommended it for approval in April.
Last month, the U.S. Food and Drug Administration (FDA) approved the vaccine, which GSK (GSK.L) plans to sell under the brand name Arexvy for people aged 60 and above, the same age group for the EU authorisation.
According to a report by news agency Reuters, the FDA also approved a similar shot, Abrysvo, by Pfizer (PFE.N) last week. Both Pfizer and GSK have said they expect a multibillion-dollar market for RSV vaccines.
GSK said on Wednesday that the first launches of the vaccine were planned ahead of the 2023/2024 RSV season, which typically starts in the autumn.
The British drugmaker is relying in part on the vaccine to drive long-term growth, with the pending loss of patent protection of its HIV compounds and setbacks in its marketed oncology portfolio, as reported by Reuters.
The EMA had said Arexvy was reviewed under its accelerated assessment route for its committee to recommend authorisation of drugs. EMA recommendations are usually followed by the European Commission in final decisions on drug approvals.
RSV, a common contagious virus affecting the lungs and breathing passages, usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalisation.
In Europe, RSV leads to over 270,000 hospitalisations and about 20,000 in-hospital deaths in adults 60 years of age and older each year.
(With inputs from Reuters)