Bharat Biotech on Monday announced that the World Health Organisation (WHO) has awarded prequalification to its rotavirus vaccine, Rotavac 5D.

The new variant of Rotavac 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.

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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, the Hyderabad-based company 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 fulfil Bharat Biotech’s vision to address neglected diseases and prevent infections that continue to affect millions in the developing world,” Bharat Biotech’s Joint Managing Director Suchitra Ella said.

Bharat Biotech developed the first generation, rotavirus vaccine, Rotavac under a public-private partnership with the 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, 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 2 million hospitalisations worldwide. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP.

Bharat Biotech has so far supplied more than 250 million doses of Rotavac.