The World Health Organization (WHO) has awarded global prequalification to Rotarix, a rotavirus vaccine produced by GlaxoSmithKline (GSK).
Rotarix is already registered in more than 100 countries worldwide, and is approved by major regulatory agencies such as the European Medicines Agency and the US Food and Drug Administration.
GSK Biologicals CEO Jean Stephenne said that 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.
GSK Biologicals has now launched Rotarix in Latin America as part of the new ‘South-first’ access strategy.