Bharat Biotech has announced that the World Health Organization (WHO) has awarded prequalification to its rotavirus vaccine, ROTAVAC 5D.

The new variant of ROTAVAC, 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 paediatric vaccines. WHO prequalification of ROTAVAC 5D will fast-track global access to this life-saving vaccine.

Suchitra Ella, Joint MD, 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."

Rotavirus is the leading cause of severe diarrhoea among children less than five years of age around the world, resulting in more than 200,000 deaths and two million hospitalisations worldwide.