PATH welcomes the news that Indian vaccine manufacturer Bharat Biotech has launched their new oral rotavirus vaccine, ROTAVAC®, in the private market in India. ROTAVAC® was developed and manufactured in India, and the vaccine was licensed by the Drugs Controller General of India (DCGI) in early 2014. As a partner in the development of ROTAVAC® since 2001, PATH worked with the Indian Department of Biotechnology, the Society for Applied Studies, and Bharat Biotech on the clinical trials that demonstrated the safety and efficacy of the vaccine.
The launch of ROTAVAC® in India’s private market is an exciting and encouraging first step towards the public health goal of improving the supply of affordable rotavirus vaccines, both in India and worldwide. Rotavirus accounts for approximately one-third of the nearly 600,000 global child deaths attributable to diarrhea each year, with an estimated 78,000 of these deaths occurring in India alone.
In July 2014, the Indian Prime Minister announced the introduction of ROTAVAC® into the publicly funded Universal Immunization Programme (UIP). The Government of India is currently developing a plan for a phased roll-out of the vaccine. Reaching all children in India with rotavirus vaccine through the UIP will benefit the poorest populations who are most at-risk of severe illness or death from rotavirus diarrhea.
ROTAVAC®’s proven safety and efficacy
ROTAVAC® was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The ROTAVAC® Phase 3 trial data showed the vaccine to have an excellent safety and efficacy profile, indicating that ROTAVAC® significantly reduced severe rotavirus diarrhea by more than half–56 percent during the first year of life, with protection continuing into the second year of life. This compares favorably with the efficacy of the other currently licensed rotavirus vaccines in low-resource countries.
A collaborative vaccine development pathway
ROTAVAC® is administered to infants at the ages of 6, 10, and 14 weeks. The vaccine originated in India from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have included the Government of India’s Department of Biotechnology, Society for Applied Studies, Bharat Biotech, the US National Institutes of Health, the US Centers for Disease Control and Prevention, Stanford University School of Medicine, and PATH. The vaccine development partnership was supported by the Department of Biotechnology, the Bill & Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development. Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development.
Posted March 9, 2015.