Essential medicines and health products

WHO prequalifies new rotavirus vaccine

On 25 September, WHO prequalified Rotasil, an oral rotavirus vaccine produced by Serum Institute of India. Rotasil is the first Rotavirus vaccine with heat stable characteristics, which makes it particularly suitable for use in low-income countries, where weak infrastructure and frequent lack of electricity make refrigeration very difficult.

WHO prequalification means that UN agencies and Gavi, the Global Vaccine Alliance, can procure the vaccine to countries based on the WHO recommendation that it is of acceptable quality, safe and effective.

Rotavirus is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in parts of Africa and Asia.

Because the condition is so widespread and serious, rotavirus vaccines should be included in all national immunization programmes and considered a priority, particularly in countries with high associated death rates, such as in south and south-eastern Asia and sub-Saharan Africa.

The addition of Rotasil to the WHO list of Prequalified vaccines will help to expand the global supply of rotavirus vaccines, increasing countries’ options to address the disease. It is also possible that it will reduce the price of available quality-assured vaccines through greater competition.

The other WHO-prequalified available vaccines for rotavirus are (RV1) Rotarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium), the pentavalent (RV5) RotaTeq® (Merck & Co. Inc., West Point, PA, USA) and Rotavac (Bharat Biotech International Limited India).