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The World Health Organisation (WHO) has awarded prequalification to Bharat Biotech's rotavirus vaccine, the Hyderabad-based company announced on Monday.
Bharat Biotech claims that its ROTAVAC 5D is the world's first and only liquid rotavirus vaccine formulation with lowest dosage form. It is used for the prevention of rotavirus infection, which is prevalent in infants and young children worldwide.
Rotaviruses are the most common cause of severe diarrhoeal disease in children less than five years of age around the world, causing more than 2 million hospitalisations worldwide, according to the WHO. Transmission of rotaviruses occurs primarily by the faecal-oral route, directly from person to person or indirectly via contaminated fomites. Rotavirus vaccine is considered the best way to protect children against rotavirus disease. The US CDC states that all children should receive all doses of rotavirus vaccine before they turn 8 months old.
WHO prequalification is a validation of the global quality and safety standards required for paediatric vaccines. This will enable the procurement of Rotavac 5D by UN agencies, namely UNICEF and PAHO, and thus fast-track global access to this life-saving vaccine, the 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 30 years 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," Bharat Biotech's Joint Managing Director Suchitra Ella said, as quoted by IANS.
The company says that ROTAVAC 5D can be stored at 2-8 C for up to 24 months. "It is a monovalent vaccine containing suspension of live, naturally attenuated rotavirus neonatal 116E strain prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 mL ROTAVAC 5D contains not less than 105.0 FFU [Focus forming unit] of live rotavirus 116E and is administered in five drops as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age," states the product about page.
Its low dose volume facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination, according to the company.
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