Bharat Biotech on August 2 said its Rotavirus vaccine ROTAVAC 5D was awarded World Health Organization (WHO) prequalification.
ROTAVAC 5D is used for the prevention of rotavirus infection, which is prevalent in infants and young children.
The 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 pediatric vaccines. WHO prequalification of ROTAVAC 5D will fast-track global access to this life saving vaccine," Bharat Biotech said.
ROTAVAC 5D is the new formulation of original rotavirus vaccine ROTAVAC developed by Bharat Biotech. The rotavirus vaccine formulation can be administered without a buffer or pH stabilising agent used in vaccine formulations.
ROTAVAC-5D is low dose volume (0.5 mL) facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination, Bharat Biotech said.
Bharat Biotech has so far supplied more than 250 million doses of ROTAVAC vaccine.
“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.