June 7 (Reuters) - European regulators have approved the region's first vaccine for respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths annually.
The shot, called Arexvy, is made by British drugmaker GSK (GSK.L) and is designed to protect people aged 60 and over.
The complex molecular structure of the virus and safety concerns with previous vaccine attempts had stymied efforts to successfully develop a shot since the virus was first discovered in 1956.
Given the different definitions of the trial endpoints across the GSK and Pfizer trials, a direct comparison of efficacy is difficult.
In Europe, RSV leads to over 270,000 hospitalisations and about 20,000 in-hospital deaths in adults over 60 each year.
Persons:
Luke Miels, Peter Welford, TD Cowen, Steve Scala, Natalie Grover, Eva Mathews, Maggie Fick, Savio D'Souza, Mark Potter
Organizations:
GSK, European Commission, European Medicines Agency, Reuters, U.S . Food, Drug Administration, Pfizer, Jefferies, Thomson
Locations:
British, Europe, U.S, London, Bengaluru