GSK notes ‘importance’ of immunising against rotavirus

GlaxoSmithKline (GSK) has noted the importance of immunising children against rotavirus, a leading cause of severe acute gastroenteritis that can result in dehydration and diarrhoea.

The company has consequently submitted Rotarix, its candidate vaccine for the prevention of this condition, to the regulatory authorities.

A biologics license application for the drug was accepted for review by the US Food and Drug Administration this week, with clinical trial data suggesting that immunity from natural human rotavirus infection can provide important protection against the disease, regardless of the strain of the virus.

Rotarix is an orally-administered live-attenuated rotavirus candidate vaccine already licensed in 99 countries worldwide that is designed to prevent rotavirus gastroenteritis through the mimicking of natural infection.

Barbara Howe, vice-president of North American vaccine development at GSK, said: “This vaccine, which is designed to protect in a manner similar to natural human infection, could make a considerable contribution in protecting very young infants from rotavirus disease”

She added that it is vital to protect infants from the disease as early as possible, with the condition a major problem for both families and healthcare services.

In May 2007, GSK presented trial data from Europe suggesting that Rotarix protects 96 per cent of infant patients from rotaviruses and reduces hospitalisation in all cases.