GSK to launch final testing of respiratory syncytial virus vaccine
GSK said Phase III studies, with the potential to produce data for regulatory approval, would likely start over the coming months.
Frankfurt: GlaxoSmithKline said it would move its experimental vaccine against the respiratory syncytial virus (RSV), a cause of pneumonia in toddlers and the elderly, into the final stage of testing, encouraged by mid-stage trial results.
RSV vaccine development has been fraught with setbacks for decades but the pharma industry is gearing up to bring a first inoculation to market over the next few years.
The area is a key growth opportunity for GSK, as it seeks to offset declining sales of its blockbuster lung drug Advair due to generic competition.
GSK said a Phase I/II trial with about 1,000 healthy adults aged 60-80 showed that the vaccine prompted a "robust" increase in antibodies and immune cells one month after injection, indicating a stimulated immune system.
A separate product, designed to give pregnant women the ability to confer immunity to their unborn children, led to high levels of protective neutralising antibodies in non-pregnant healthy woman taking part in a Phase I/II trial.
GSK said Phase III studies, with the potential to produce data for regulatory approval, would likely start over the coming months.
The vaccines were well-tolerated with side effects including injection-site pain and headache, GSK added.
Companies including Johnson &, Sanofi and Moderna are competing to get a vaccine approved against RSV, which globally leads to about 3 million hospital stays for children under five per year.
Swedish Orphan Biovitrum's Synagis, a monthly shot, is currently the only preventive treatment against RSV in high-risk infants. Sanofi and partner AstraZeneca are working on longer-acting nirsevimab, which could be given once per cold season to that group, if approved.
GSK is also conducting early-stage studies of an RSV vaccine for children and plans to publish results some time between Oct. 26-29 for a subgroup of children which already had some exposure to the virus.
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