EU gives final approval for GSK's RSV vaccine

FILE PHOTO: Illustration shows GSK (GlaxoSmithKline) logo

(Reuters) -The European Commission has approved GSK’s respiratory syncytial virus (RSV) vaccine for older adults, the drugmaker said on Wednesday, making 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 plans to sell under the brand name Arexvy for people aged 60 and above, the same age group for the EU authorisation.

The FDA also approved a similar shot, Abrysvo, by Pfizer last week.

Both Pfizer and GSK have said they expect a multibillion-dollar market for RSV vaccines.

GSK said on Wednesday that 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.

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.

(Reporting by Eva Mathews in Bengaluru; Editing by Savio D’Souza and Mark Potter)