WHO Grants Global Prequalification To GSK’s Rotarix Vaccine

The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline’s vaccine against rotavirus, Rotarix.

As part of an innovative ‘South-first’ access strategy, GSK Biologicals launched Rotarix in Latin America. Rotarix is registered in more than 100 countries worldwide, and is approved by major regulatory agencies such as the European Medicines Agency and FDA.

Jean Stephenne, CEO of GSK Biologicals, said: “Today’s approval is the culmination of a long-standing commitment at GSK to deliver a rotavirus vaccine for the world.”

“Five years ago, GSK pursued a different regulatory strategy to speed the availability of Rotarix by introducing the vaccine in developing countries first, where the medical needs and mortality rates are highest,” he added.