Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent liquid frozen vaccine containing live rotavirus 116E strain [G9 P(11)] prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 mL contains NLT 105.0 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.
Rotavirus strain 116E isolated from asymptomatic neonates born during 1986-88 at the All India Institute of Medical Sciences, New Delhi, was developed into ROTAVAC® by Bharat Biotech in collaboration with highly regarded national and international organizations. The multi-centred Phase III Efficacy and Safety clinical trial on ROTAVAC® was India’s 1st and largest efficacy clinical trial on vaccines and was successfully completed in September 2013 after a 2-year follow up of the infants. Results were published in Lancet. 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 the vaccine efficacy in the second year of the same study was 49% [95% Cl 17.5, 68.4].
ROTAVAC® is available in convenient single dose and multi-dose presentations.