Rotavac by Bharat Biotech is a monovalent liquid frozen rotavirus vaccine that contains the live rotavirus 116E strain, prepared in Vero cells, to prevent rotavirus gastroenteritis. Each 0.5 ml dose contains not less than 105.0 FFU of live Rotavirus 116E. ROTAVAC is administered as a 3-dose regimen, with 4-week intervals, beginning at 6 weeks of age. It should not be given to children older than 8 months. ROTAVAC has a shelf life of 5 years when stored at -20°C until the expiration date and can be stored for up to six months between 5°C ±3°C.
Rotavac received WHO Prequalification in January 2018. Rotavirus 116E was 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-center phase 3 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. The results of this study were published in The Lancet.
The vaccine efficacy of ROTAVAC for severe non-vaccine rotavirus gastroenteritis was 56.4% [95% CI 36.6, 70.1] in the first year of life, and efficacy in the second year was 49% [95% CI 17.5, 68.4].
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Frequently asked questions and their answers:
1. What is ROTAVAC and what is it used for?
ROTAVAC is a vaccine used to prevent Rotavirus infection. Rotavirus is a viral disease that primarily affects infants and young children. Symptoms of Rotavirus infection include severe diarrhea, vomiting, fever, dehydration, and abdominal pain. Rotavirus is highly contagious and easily spreads from one child to another. Severe cases of Rotavirus infection may require hospitalization. Vaccination with the Rotavirus vaccine is the most effective way to protect a child from Rotavirus infection.
2. What are the important considerations before administering ROTAVAC?
Before administering ROTAVAC, it is important to inform the doctor if the child:
3. How is ROTAVAC administered?
ROTAVAC is administered orally. According to the recommendation of the Indian Academy of Pediatrics (IAP), ROTAVAC should be given at 6 weeks, 10 weeks, and 14 weeks of age.
4. What are the common side effects of ROTAVAC?
Most children who receive the Rotavirus vaccine do not experience any side effects. If side effects do occur, they are typically mild and may include fussiness, diarrhea, and vomiting.
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