This was a unique group, bringing together an unusual combination of domestic and international partners, committed to social innovation with a clear goal of developing a safe and effective vaccine

that would reach the populations that most needed it at an affordable price. In 2003, BBIL Bharat convened the various partners to discuss the clinical development plan for the 116E and I321 vaccine lots. Trials conducted in 2005 showed that click here while both of them were safe, 116E provided significantly better immune response to the vaccine [5]. The development was then taken forward to late phase II and then phase III with the 116E candidate, under the leadership of Nita Bhandari at the Society for Applied Studies, a non-governmental organization formed of researchers formerly at AIIMS, committed to child health research. The partners then expanded to include researchers

Crenolanib order at the KEM hospital and Research Centre, Pune and the Christian Medical College, Vellore to carry out the phase III clinical trial for efficacy that required recruitment of 6800 infants and their follow up for a period of two years, and the Translational Health Science and Technology Institute, Delhi to analyze all the clinical samples. The clinical trial was carried out to the highest international standards, with remarkably low loss to follow up, a critical determinant of trial quality. In addition, the intensive monitoring and follow up of participants and provision of access to medical care the and referrals resulted in lower than expected numbers of deaths at all three sites, pointing to the attention paid to participant safety in the trial. Despite the early treatment and referrals, the data indicate that

116E based vaccine (now known as Rotavac) provided a level of protection (56% during the first year) comparable to other licensed rotavirus vaccines in developing countries [6] which did not drop significantly in the second year of life [7]. The sharing of the costs of development between several partners played a crucial role in the ability to limit the price of the vaccine to just $1 per dose. BBIL invested in a highly efficient manufacturing process and innovative product development efforts, which also contribute to keeping the costs low. This joint, very collaborative, effort has been a new paradigm for innovation in strategy and process and has resulted in the availability of safe and effective product for Indian and other developing country markets. The deployment of this product now requires further partnerships—in consideration of the introduction of the vaccine into the public health system and in continued safety surveillance.