The World Health Organisation (WHO) has awarded prequalification to Bharat Biotech’s rotavirus vaccine, Rotavac 5D.

The new variant of the Hyderabad-based vaccine maker’s Rotavac, Rotavac 5D is 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.

Safety standards

The prequalification enables the procurement of Rotavac 5D by UN agencies, Unicef and PAHO. It is a validation of the global quality and safety standards required for pediatric vaccines.

“Rotavac and Rotavac 5D are projects conceived, innovated, and executed in India, in collaboration with Indian and global partners,” said Suchitra Ella, Joint Managing Director, Bharat Biotech, in a release.

“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,” she added.

“Rotavac 5D “is safe and effective in the prevention of rotavirus diarrhoea”, said the company. It can be stored at 2-8ºC, administered in five drops orally, and is available in single-dose, multi-dose vials, and pre-filled syringes. It has been evaluated in clinical trials in India and other countries, it added.

Bharat Bio has priced Rotavac 5D vaccine dose at ₹1,430 (in pre-filled syringes) and Rotavac at ₹689.

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. It received WHO prequalification in 2018.

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 the vaccine.

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 hospitalisations worldwide. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP.