A three-dose, oral rota-virus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. Active surveillance for intussusception was conducted at 27 participating hospitals in India. KIMS is one of the sentinel surveillance centres led by Dr. Nirmal Mohakud, Associate Professor.
Conclusion: An increased risk of intussusception was not detected in any risk window after the receipt of any dose of the rotavirus vaccine under study (Rotavac) among children in India in either the self-controlled case-series analysis or the case–control analysis. The results of the post marketing, active surveillance study provide evidence that there was no adverse safety signal associated with this vaccine in the Indian population.
Age at Immunization and at Onset of Intussusception, April 2016 through June 2019.
Gray bars indicate the numbers of intussusception cases according to the age at symptom onset in the infants who were included in the self-controlled case-series analysis. Colored lines indicate the specified doses of rotavirus vaccine administered, according to the infants’ age at immunization. Data are from 27 hospitals in 10 states in India