GlaxoSmithKline’s rotavirus vaccine gets WHO prequalification status

GlaxoSmithKline recently announced that its two-dose oral rotavirus vaccine was awarded prequalification status by the World Health Organization (WHO). It is the first time a vaccine against rotavirus gastroenteritis has received such clearance.

The WHO prequalification endorses the vaccine’s quality, safety and efficacy for use in mass vaccination programs against rotavirus which is the most common cause of severe diarrhea in children under 5 years of age worldwide and is the single greatest cause of diarrhea-related deaths among children. WHO prequalification is an established mechanism to facilitate the supply of new vaccines to regions where they are most urgently needed. GSK will be the first company to offer their rotavirus vaccine to those organizations for use in mass vaccination programs.

GSK’s two-dose oral rotavirus vaccine offers early protection to infants aged 6 weeks and above for the prevention of rotavirus gastroenteritis before the peak incidence of the disease at 6-24 months of age. Currently, it has been approved in 90 countries worldwide and children in about 50 countries are already benefiting from the vaccine. GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.