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Intussusception after Rotavirus Vaccine Introduction in India.
Samarasimha N Reddy1, Nayana P Nair1, Jacqueline E Tate1
1From the Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences (S.N.R., N.P.N., V.T., S. Giri, I.P., S. Babji, S. Bidari, S. Senthamizh, G.K.), and the Department of Community Health (V.R.M.), Christian Medical College Vellore (T.J.K.J.), and Government Vellore Medical College (G.V.), Vellore, Kanchi Kamakoti Child Trust Hospital (B.S.), the National Institute of Epidemiology (G.K.C.P.), and the Institute of Child Health (P.D., M.J.), Chennai, Government Rajaji Hospital and Madurai Medical College, Madurai (K.M., H.B.), Coimbatore Medical College, Coimbatore (R.M., R. Gurusamy), the Indian Council of Medical Research, New Delhi (S. Giri, I.P., M.D.G.), Translational Health Science and Technology Institute, Faridabad (R.A., G.K.), Kurnool Medical College and Government General Hospital, Kurnool (S.M.), Government General Hospital and Rangaraya Medical College, Kakinada (K.B.G., B.R.), King George Hospital and Andhra Medical College, Visakhapatnam (P.P., R.P.G.), Sri Venkateshwara Medical College, Tirupati (M.B., V.M.), Sardar Valla Bhai Patel Post Graduate Institute of Paediatrics, Cuttack (S. Sathpathy, H.M.), the Institute of Medical Sciences and SUM Hospital, Bhubaneswar (M.D.), Kalinga Institute of Medical Sciences (N.K.M.) and Hi-Tech Hospital (R.K.R., P.M.), Bhubaneswar, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak (G.G.), Shaheed Hasan Khan Mewati Government Medical College, Mewat (S.C.), Post Graduate Institute of Medical Education and Research, Chandigarh (M.G.), Sawai Man Singh Medical College, Jaipur (R. Gupta), Rabindranath Tagore Medical College, Udaipur (S. Goyal), Dr. Sampurnanand Medical College, Jodhpur (P.S.), Malankara Orthodox Syrian Church Medical College Hospital, Kolencherry (M.A.M.), Jawaharlal Nehru Institute of Post-graduate Medical Education and Research, Puducherry (S.K., A.S.), Mahatma Gandhi Memorial Medical College, Indore (H.J.), the Government Medical College, Guwahati, Assam (J.K.G.), King George Medical College, Lucknow (A.W.), and the Institute of Medical Sciences, Banaras Hindu University, Varanasi (V.G.) - all in India; and the Centers for Disease Control and Prevention, Atlanta (J.E.T., U.D.P.).
The Indian rotavirus vaccine (Rotavac) showed no increased risk of intussusception in infants. This study provides crucial safety data for rotavirus vaccination programs in India.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Public Health Surveillance
Background:
- Rotavirus vaccine (Rotavac) introduced in India's universal immunization program in 2016.
- Prelicensure trials were insufficient to detect small risks of intussusception.
- Postmarketing surveillance is vital for assessing vaccine safety compared to international data.
Purpose of the Study:
- To evaluate the risk of intussusception following oral rotavirus vaccination in Indian infants.
- To compare intussusception incidence during specific risk windows post-vaccination with non-risk periods.
Main Methods:
- Multicenter, hospital-based active surveillance study across 27 Indian hospitals.
- Self-controlled case-series analysis of infants (28-365 days) with radiologically or surgically confirmed intussusception.
- Vaccination status ascertained via records; matched case-control analysis performed on a subgroup.
Main Results:
- 970 infants with intussusception enrolled; 589 included in the primary analysis.
- No statistically significant increased relative incidence of intussusception observed after any of the three vaccine doses.
- Relative incidence values in risk windows (1-7 days, 8-21 days) were consistently below 1, indicating no increased risk.
Conclusions:
- The oral rotavirus vaccine used in India is not associated with an increased risk of intussusception in Indian infants.
- Findings support the safety profile of this rotavirus vaccine in a large-scale public health program.
- The study provides essential safety data for ongoing rotavirus vaccine use and policy.
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