Indigenously-developed rotavirus vaccine

a case-study of ROTAVAC in India

Abstract

India has a high burden of rotavirus, a disease that causes gastroenteritis. ROTAVAC is an indigenously-developed rotavirus vaccine that was researched and manufactured in India by Bharat Biotech. It was introduced in India’s Universal Immunization Program in four states in 2016 and expanded to five more in 2017. While its efficacy rate is similar to that of other rotavirus vaccines, it is far cheaper, making its introduction in the Indian health care system cost-efficient. Bharat Biotech were able to market ROTAVAC at only USD 1 per dose due to savings incurred by manufacturing locally, and the innovative team science approach used in the vaccine development. Challenges in implementing ROTAVAC remain, including lack of funding, vaccine coverage disparities and a lack of medical consensus on the vaccine’s importance. The absence of data on project funding, vaccine uptake and rotavirus incidence rates renders a conclusive analysis difficult, and stresses the importance of strong surveillance systems and data transparency. Despite such challenges, ROTAVAC remains an encouraging example of a low-income country researching and developing a successful vaccine, a process usually reserved for high-income countries. Its development and WHO pre-qualification have immense potential to reduce the rotavirus burden in India and other developing nations.