Bharat Biotech’s new variant of vaccine gets WHO pre-qualification

Bharat Biotech on Monday said rotavirus vaccine Rotavac 5D has received World Health Organisation’s (WHO) pre-qualification, a development that is expected to fast-track procurement and global access of the new variant of Rotavac.

“WHO pre-qualification enables the procurement of Rotavac 5D by UNICEF and PAHO... will fast-track global access to this life saving vaccine. It is a validation of the global quality and safety standards required for paediatric vaccines,” the vaccine maker said in a statement.

Used for prevention of rotavirus infection, which is a cause of severe diarrhoea and prevalent in infants and young children, the low dose volume (0.5 mL) of Rotavac 5D facilitates easy logistics, cold chain management and low biomedical waste disposal post-vaccination. The new variant is a unique rotavirus vaccine formulation that can be administered without a buffer, Bharat Biotech said.

A miniaturised affordable rotavirus vaccine, delivering a potent product with a dose volume of 0.5ml, Rotavac 5D enables complete delivery of the antigenic payload in five oral drops, avoiding spit-ups observed with larger dose volumes. The variant, evaluated in clinical trials in India and other countries, can be stored at 2-8 degrees C and is available in single-dose, multi-dose vials and pre-filled syringes, the statement said.

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

Bharat Biotech said it had developed the first generation, rotavirus vaccine Rotavac under a public-private partnership with the Centre’s Department of Biotechnology and 16 international partners, making it the largest ever social innovation project for public health. The company has thus supplied over 250 million doses of Rotavac.

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Printable version | Sep 29, 2021 1:11:12 AM | https://www.thehindu.com/news/cities/Hyderabad/bharat-biotechs-new-variant-of-vaccine-gets-who-pre-qualification/article35683333.ece

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