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Multicenter Study
. 2020 Nov 12;383(20):1932-1940.
doi: 10.1056/NEJMoa2002276.

Intussusception after Rotavirus Vaccine Introduction in India

Samarasimha N Reddy  1 , Nayana P Nair  1 , Jacqueline E Tate  1 , Varunkumar Thiyagarajan  1 , Sidhartha Giri  1 , Ira Praharaj  1 , Venkata R Mohan  1 , Sudhir Babji  1 , Mohan D Gupte  1 , Rashmi Arora  1 , Sunita Bidari  1 , Sowmiya Senthamizh  1 , Suhasini Mekala  1 , Krishna B Goru  1 , Bhaskar Reddy  1 , Padmalatha Pamu  1 , Rajendra P Gorthi  1 , Manohar Badur  1 , Vittal Mohan  1 , Saroj Sathpathy  1 , Hiranya Mohanty  1 , Mrutunjay Dash  1 , Nirmal K Mohakud  1 , Rajib K Ray  1 , Prasantajyoti Mohanty  1 , Geeta Gathwala  1 , Suraj Chawla  1 , Madhu Gupta  1 , Rajkumar Gupta  1 , Suresh Goyal  1 , Pramod Sharma  1 , Mannancheril A Mathew  1 , Tarun J K Jacob  1 , Balasubramanian Sundaram  1 , Girish K C Purushothaman  1 , Priyadarishini Dorairaj  1 , Muthukumaran Jagannatham  1 , Kulandaivel Murugiah  1 , Hemanthkumar Boopathy  1 , Raghul Maniam  1 , Rajamani Gurusamy  1 , Sambandan Kumaravel  1 , Ashwitha Shenoy  1 , Hemant Jain  1 , Jayanta K Goswami  1 , Ashish Wakhlu  1 , Vineeta Gupta  1 , Gopinath Vinayagamurthy  1 , Umesh D Parashar  1 , Gagandeep Kang  1
Affiliations
Multicenter Study

Intussusception after Rotavirus Vaccine Introduction in India

Samarasimha N Reddy et al. N Engl J Med. .

Abstract

Background: A three-dose, oral rotavirus 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.

Methods: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location.

Results: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis.

Conclusions: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

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Conflict of interest statement

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.

Figures

Figure 1
Figure 1
Age at immunization and at onset of intussusception (IS) in Indian infants included in the SCCS analysis from 27 hospitals in ten Indian states, April 2016 through June 2019
Figure 2
Figure 2
Cases of intussusception occurring in the 0-59 days# after dose 1, dose 2 and dose 3 of Rotavac® vaccine from 27 hospitals in 10 Indian states, April 2016 through June 2019 # An additional 345 cases occurred more than 60 days after dose 1, an additional 265 cases occurred more than 60 days after dose 2, and an additional 181 cases occurred more than 60 days after dose 3
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