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. 2020 Jul 14;38(33):5241-5248.
doi: 10.1016/j.vaccine.2020.05.093. Epub 2020 Jun 16.

Assessment of risk of intussusception after pilot rollout of rotavirus vaccine in the Indian public health system

Early Rollout of ROTAVAC®India Network
Collaborators, Affiliations

Assessment of risk of intussusception after pilot rollout of rotavirus vaccine in the Indian public health system

Early Rollout of ROTAVAC®India Network. Vaccine. .

Abstract

Background: Pre-licensure trials of ROTAVAC® were not adequately powered to assess risk of intussusception, a rare adverse event associated with other rotavirus vaccines in some settings. We examined the risk of intussusception after ROTAVAC® vaccination among Indian infants during pilot rollout of the vaccine in the public health system in three states - Himachal Pradesh, Maharashtra and Tamil Nadu.

Methods: Passive surveillance for intussusception was set up in 35 sentinel health facilities covering 26.3 million population in the three states under monitoring of an Interministerial-Interagency Steering Committee. Clinical and immunization data were collected by independent teams. An expert committee blinded to vaccination status, classified intussusception cases using Brighton criteria. The self-controlled case-series method was used to estimate risk of intussusception (Brighton Level 1) after ROTAVAC® vaccination.

Results: 151 intussusception cases were included in the analysis. The relative incidence (incidence during the risk period compared to the control period) 1-21 days after doses 1 and 2 combined was 1.56 (95% CI, 0.0-5.28) and that for three doses combined was 1.88 (95% CI, 0.76-4.30). Attributable risk 1-21 days after doses 1 and 2 combined was 0.11 (95% CI, 0.0-0.25) and that for 3 doses combined was 0.42 (95% CI, 0.0-0.70) per 100,000 doses.

Conclusions: No increased risk of intussusception within 21 days of receipt of the first two doses combined or all 3 doses combined of ROTAVAC® was detected.

Keywords: Intussusception; Rotavirus vaccine; Vaccine safety.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Flowchart showing the intussusception cases and those included or excluded from the analysis.
Fig. 2
Fig. 2
Cases of Intussusception after the three doses of ROTAVAC® vaccine.
Fig. 3
Fig. 3
Age at immunization and onset of intussusception in infants.
See this image and copyright information in PMC

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