WHO grants global prequalification to GSK’s Rotarix vaccine
The World Health Organization has issued global prequalification for GSK’s Rotarix vaccine, a move intended to facilitate wider distribution across Asia and Africa.
The World Health Organization (WHO) has granted global prequalification to GlaxoSmithKline’s Rotarix vaccine for the prevention of rotavirus. The decision, complemented by a recommendation from the WHO’s Strategic Advisory Group of Experts (SAGE) for national immunization programs, enables UN agencies and the GAVI Alliance to procure the vaccine for use in developing nations.
Rotavirus remains a leading cause of severe diarrheal illness and mortality among children under five years of age. Prequalification confirms that the vaccine meets international standards for quality, safety, and efficacy, which is a prerequisite for large-scale international health procurement.
GSK Biologicals noted that the vaccine had been introduced in parts of Latin America prior to major Western markets, forming part of an access strategy to reach populations with the highest medical need. The oral two-dose vaccine has undergone clinical trials across five continents and is currently registered in over 100 countries.