WHO pre-qualifies rotavirus vaccine, Rotasiil from India

Achieving WHO prequalification means that Rotasiil will now be available for use in low and middle-income countries

PATH welcomes the World Health Organization’s (WHO’s) prequalification of the thermostable rotavirus vaccine, Rotasiil, manufactured by Serum Institute of India. The vaccine, which prevents severe rotavirus-induced diarrhea in infants, provides an innovative and affordable option to the global market as it is the first rotavirus vaccine that does not require constant refrigeration and will help meet the critical public health goal of improving vaccine supply worldwide.

Achieving WHO prequalification means that Rotasiil will now be available for procurement by United Nations agencies and Gavi, the Vaccine Alliance, for use in low- and middle-income countries. This will help accelerate availability of the vaccine in countries experiencing the highest burden of rotavirus-induced diarrhea by providing a practical and affordable option for vaccine introduction.

Rotavirus is the most common cause of severe diarrheal disease in children worldwide, and vaccination is the best way to prevent severe rotavirus illness. According to a recent study, 37 percent of global childhood diarrheal deaths in 2013 were due to rotavirus, a total of 2,15,000 rotavirus deaths. More than 90 per cent of these deaths occurred in low-resource settings.

The international nonprofit PATH partnered with Serum Institute on evaluating Rotasiil in the Phase 3 studies conducted in India and assisted with their applications for local licensure and WHO prequalification. PATH is continuing to work with Serum Institute on additional studies on Rotasiil effectiveness (disease reduction in the population) and cost-effectiveness of the vaccine in India.

“PATH congratulates our partner, Serum Institute of India, for achieving the critical milestone for global access, WHO prequalification, of their oral rotavirus vaccine, Rotasiil. PATH looks forward to contributing to the ongoing evaluation of this vaccine, and seeing a thermostable product added to the global supply of rotavirus vaccines in the fight against diarrheal disease,” said Dr David C. Kaslow, PATH’s Vice President for Essential Medicines and global head of the Center for Vaccine Innovation and Access.

Rotasiil is an oral vaccine administered to infants in a three-dose course at six, 10, and 14 weeks of age, at the same time as routine vaccinations. The WHO-prequalified Rotasiil formulation is a lyophilized (freeze-dried) presentation packaged in single-dose vials alongside a diluent.