Hyderabad: Bharat Biotech on Monday announced that the World Health Organization (WHO) has awarded prequalification to its rotavirus vaccine, Rotavac 5D.
Rotavac 5D is a unique rotavirus vaccine formulation that can be administered without a buffer. Its low dose volume (0.5 mL) facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination. It is used for the prevention of rotavirus infection which is prevalent in infants and young children.
WHO prequalification enables the procurement of Rotavac 5D by UN agencies namely UNICEF and PAHO. It is a validation of the global quality and safety standards required for pediatric vaccines. WHO prequalification of Rotavac 5D will fast-track global access to this life-saving vaccine.
Suchitra Ella, the joint managing director of Bharat Biotech, said, "Rotavac and Rotavac 5D are projects conceived, innovated, and executed in India in collaboration with Indian and global partners. This is the culmination of a 30-year effort to develop a novel rotavirus vaccine, resulting in a major advancement in Rotavirus disease prevention and reasserts India's leadership in developing and introducing rotavirus vaccines for the world. Today's announcement is an important step to further strengthen and fulfill Bharat Biotech's vision to address neglected diseases and prevent infections that continue to affect millions in the developing world."
Bharat Biotech developed the first generation rotavirus vaccine Rotavac under a public-private partnership with the Centre's department of biotechnology and 16 other international partners making it the largest ever social innovation project for public health. In the developing world, Rotavac has been instrumental in addressing deaths due to rotavirus infection. Bharat Biotech has so far supplied more than 250 million doses of Rotavac.
Rotavirus is the leading cause of severe diarrhea among children less than five years of age around the world, resulting in more than 200,000 deaths and 2 million hospitalizations worldwide.
Rotavac 5D is safe and effective in the prevention of rotavirus diarrhoea. It can be stored at 2-8ºC and administered in five drops orally. Rotavac 5D is available in single-dose, multi-dose vials, and pre-filled syringes. It has been evaluated in clinical trials in India and other countries. The vaccine is safe, effective, and affordable besides being cross-protective against a variety of rotavirus strains. Its efficacy compares favorably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries.