Bharat Biotech’s ROTAVAC 5D receives WHO pre-qualification

Bharat Biotech has announced that the World Health Organization (WHO) has awarded pre-qualification to its rotavirus vaccine, ROTAVAC 5D. The new variant of ROTAVAC, ROTAVAC 5D, is a  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, the company said in a statement.

WHO pre-qualification enables the procurement of ROTAVAC 5D by the 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, it said.

Speaking on the development, Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “ROTAVAC and ROTAVAC 5D are the 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 Department of Biotechnology, Government of India 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, mentioned the statement.