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(Alliance News) - GSK PLC on Thursday said a New England Journal of Medicine publication announced positive phase III trial results for its respiratory syncytial virus vaccine candidate for older adults.
GSK said it is on track for an approved RSV vaccine this year, awaiting regulatory decisions in the US and EU, and other countries.
The Brentford, London-based pharmaceutical company said the publication showed that the vaccine candidate met the primary endpoint of vaccine efficacy against RSV-lower respiratory tract disease in adults aged 60 and over, with a favourable safety profile.
Chief Scientific Officer Tony Wood said: "We are delighted to publish these exceptional data in the New England Journal of Medicine. We look forward to making the vaccine available as quickly as possible, pending regulatory decisions, and sharing more data from our ongoing clinical development programme as we work to get ahead of this potentially debilitating virus."
GSK aims to produce the first approved RSV vaccine. However, in January, Moderna Inc had reported positive interim trial results on its potential RSV virus vaccine, receiving US Food & Drug Administration breakthrough therapy designation.
GSK's RSV vaccine in November received priority review from the FDA, but is short of a breakthrough therapy designation.
GSK on Thursday said: "GSK is the first company to publish positive peer-reviewed phase III data for an RSV older adult vaccine candidate."
GSK shares were 0.8% higher at 1,468.99 pence each on Thursday morning in London.
By Tom Budszus, Alliance News reporter
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