The New England Journal of Medicine (NEJM) published the first study demonstrating that Rotarix, GlaxoSmithKline’s rotavirus vaccine, significantly prevented severe rotavirus gastroenteritis during the first year of life in African babies. In the study Rotarix prevented the disease in 61.2 per cent of these infants. The study also showed that Rotarix provided broad protection against diverse circulating rotavirus strains.

“Rotavirus disease has caused more than five millions deaths in infants and young children over the last decade. It is time to act to avoid these unnecessary deaths and hospitalisations from rotavirus gastroenteritis. GSK is committed to working with our partners to help ensure that Rotarix™ reaches those in need, wherever they live,” commented Thomas Breuer, head of Global Clinical R&D and chief medical officer of GSK Biologicals.

Rotavirus is a contagious infection that kills an estimated 1,600 children under the age of five every day, most of these deaths are in Africa and Asia. In addition, six of the seven countries with the highest rotavirus diarrhoea mortality rates are located in Africa. The high number of severe rotavirus gastroenteritis cases and associated deaths in Africa means that Rotarix vaccination may have an even greater public health impact than in developed countries where parents have easy access to hospitals.

“Measures to prevent rotavirus diarrhoea are urgently needed for African children,” commented study author professor Shabir Madhi, professor of Vaccinology, University of the Witwatersrand, South Africa. “We have shown that immunisation during early infancy can significantly reduce the burden of gastroenteritis, even in the most challenging of settings, such as Africa.”

The trial was designed to accumulate data from Africa and include populations that would be broadly representative of those in developing countries. These data suggest that, when introduced into standard childhood vaccination schedules in similar settings across Africa, Rotarix is expected to have a considerable public health benefit.

Rotarix is generally well-tolerated. The most common adverse events after vaccination are fever, fatigue, irritability and gastrointestinal disorders.

In April 2009, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunisation programmes. Based on this decision, the WHO awarded global prequalification to Rotarix. These decisions have opened the door to making rotavirus vaccines available to children worldwide.

Rotarix is a two-dose, orally-administered vaccine that offers early protection against rotavirus to infants.