Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent liquid frozen vaccine containing live rotavirus 116E strain prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 ml contains NLT 10^5.0 FFU of live Rotavirus 116E. ROTAVAC^® should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age and should not be administered to children older than 8 months of age. ROTAVAC^® has a shelf life of 5 years when stored at -20°C till the expiry date and can be stored for up to six months between 5°C ±3°C.

Rotavac^® received WHO-Prequalification in January 2018. Rotavirus 116E is isolated from asymptomatic neonates in 1986-88 at the All India Institute of Medical Sciences, New Delhi. ROTAVAC^® was developed as a Social Innovation Project under a public-private partnership involving highly-regarded national and international organizations. The multi-centre phase3 efficacy and safety clinical trial on ROTAVAC^® was India’s first and largest efficacy clinical trial on vaccines. It was successfully completed in September 2013 after a 2-year follow up of the infants. Results of this study were published in theLancet.

The vaccine efficacy of ROTAVAC^® for severe non-vaccine rotavirus gastroenteritis was 56.4% [95% Cl 36.6, 70.1] in the first year of life and efficacy in the second year was 49% [95% Cl 17.5, 68.4].

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