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Rotavac Vaccination in Kolkata


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Rotavac Vaccination

Availability: Service available Location: Vaccination at centre/ Home Vaccination Category: Rotavirus

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].


Indication and Usage –

  • 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. 
  • It is usually given as a 3-dose oral regimen, 4 weeks apart, beginning at 6 weeks of age.
  • It helps protect the baby from a kind of virus (rotavirus) that can cause bad diarrhea.

Dosage and Administration –

  • For oral use only. Not for injection.
  • Rotavirus Vaccine, Live Attenuated (Oral) should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age.

Contraindications –

  • Hypersensitivity to any component of the vaccine. Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of Rotavac should not receive further doses of Rotavac.
  • Individuals with Severe Combined Immunodeficiency Disease (SCID). Cases of gastroenteritis associated with live rotavirus vaccines have been reported in infants with SCID.
  • History of intussusception (IS).

Adverse reactions –

  • Side effects are rare, however, some may experience mild irritability, cough, fever, loss of appetite, and vomiting.
  • If the child experience any of such side effects and that does not go away with time or get worse, you should let your doctor know. The doctor may help with ways to reduce or prevent these symptoms.

Drug interactions and other interactions –

  • No interaction studies have been performed in infants with other medicinal products, for use with other vaccines.
  • Rotavac is a pediatric vaccine and should not be administered to adults including pregnant women.
  • There was no evidence to suggest that breast-feeding reduced the protection against rotavirus gastroenteritis conferred by Rotavac.


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:

  • Has previously experienced a severe allergic reaction to the Rotavirus vaccine.
  • Is severely allergic to any of the vaccine's ingredients.
  • Has an immunodeficiency disorder.
  • Has had intussusception.


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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