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

Bhandari, Nita; Antony, Kalpana; Balraj, Vinohar; Rongsen-Chandola, Temsunaro; Kumar, Tivendra; Sinha, Bireshwar; Goyal, Nidhi; Guleri, Rajesh; Bavdekar, Ashish; Juvekar, Sanjay; Dayma, Girish; Patwardhan, Vaijayanti; Patil, Archana Vasantrao; Kang, Gagandeep; Mohan, Venkata Raghava; Srinivasan, Rajan; Naaraayan, Sridevi A; Reddy, Samarasimha; Bhan, Maharaj Kishan; Rao, T. Srinivasa; Parashar, Umesh D.; Muliyil, Jaya Prakash; Tate, J. E.; Andrews, Nicholas; Samuel, Prasanna; Ganesan, Santhosh Kumar; Taneja, Sunita; Choudhary, Tarun Shankar; Bhatnagar, Veereshwar; Gupta, Arun Kumar; Kabra, Madhulika

doi:10.1016/j.vaccine.2020.05.093

Cited by 11 publications

(7 citation statements)

References 19 publications

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“…The relative incidences of intussusception during 1–21 days after RVV1 and RVV2 (RI: 1.56; 95% CI: 0.0–5.28) and any RVV dose (RI: 1.51; 95% CI: 0.58–3.23). The findings from our study are comparable to observations from this report [41] , [42] . Second, only cases from selected hospitals were included and no definite catchment area or population base could be ascertained to derive the incidence rate.…”

Section: Discussionsupporting

confidence: 92%

Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis

Das¹,

Arora²,

Poluru³

et al. 2021

Vaccine

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Background An association between rotavirus vaccination and intussusception has been documented in post-licensure studies in some countries. We evaluated the risk of intussusception associated with monovalent rotavirus vaccine (Rotavac) administered at 6, 10 and 14 weeks of age in India. Methods Active prospective surveillance for intussusception was conducted at 22 hospitals across 16 states from April 2016 through September 2017. Data on demography, clinical features and vaccination were documented. Age-adjusted relative incidence for 1–7, 8–21, and 1–21 days after rotavirus vaccination in children aged 28–364 days at intussusception onset was estimated using the self-controlled case-series (SCCS) method. Only Brighton Collaboration level 1 cases were included. Results Out of 670 children aged 2–23 months with intussusception, 311 (46.4%) children were aged 28–364 days with confirmed vaccination status. Out of these, 52 intussusception cases with confirmed receipt of RVV were included in the SCCS analysis. No intussusception case was observed within 21 days of dose 1. Only one case occurred during 8–21 days after the dose 2. Post-dose 3, two cases in 1–7 days and 7 cases during 8–21 days period were observed. There was no increased risk of intussusception during 1–7 days after the doses 1 and 2 (zero cases observed) or dose 3 (relative incidence [RI], 1.71 [95% confidence interval {CI} 0.0–5.11]). Similarly, no increased risk during 8–21 days after the dose 1 (zero cases observed), dose 2 (RI, 0.71 [95% CI, 0.0–3.28]) or dose 3 (RI, 2.52 [95% CI, 0.78–5.61]). The results were similar for 1–21 day periods after the doses separately or pooled. Conclusions The risk of intussusception during the first 21 days after any dose of rotavirus vaccine (Rotavac) was not higher among the Indian infants than the background risk, based on limited SCCS analysis of 52 children.

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Section: Discussionsupporting

confidence: 92%

Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis

Das¹,

Arora²,

Poluru³

et al. 2021

Vaccine

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“…41 Attributable risk 1-21 d after the first and second doses (combined) was 0.11 (95% CI: 0.0-0.25) per 100,000 doses, and 0.42 (95% CI: 0.0-.70) per 100,000 doses for all three doses combined; no clustering of cases was seen after any dose. 41 The analysis found no increased risk of intussusception during the first 21 d following any of the three doses of ROTAVAC or all three doses combined, compared to the control period (d 22-365). 41 As reported at the December 2019 meeting of the Global Advisory Committee on Vaccine Safety, active sentinel site surveillance was conducted across 28 hospitals in nine states in India following the introduction of ROTAVAC, with analysis of cases meeting Brighton Level 1 criteria to assess possible association of ROTAVAC vaccination and intussusception.…”

Section: Surveillancementioning

confidence: 91%

“…38 Recent post-licensure analysis of surveillance data from India, specifically states that have introduced ROTAVAC, has also found no increased risk of intussusception; these reports are summarized below. 41,42…”

Section: Vaccine Backgroundmentioning

confidence: 99%

“…From 2015 to 2019, passive surveillance was conducted at 35 health facilities across three Indian states -Himachal Pradesh, Maharashtra, and Tamil Nadu -to better understand and estimate the risk of intussusception among infants vaccinated with ROTAVAC. 41 A total of 151 intussusception cases meeting Brighton Level 1 criteria were identified; of these, 104 were vaccinated with ROTAVAC and 47 were unvaccinated. 41 Attributable risk 1-21 d after the first and second doses (combined) was 0.11 (95% CI: 0.0-0.25) per 100,000 doses, and 0.42 (95% CI: 0.0-.70) per 100,000 doses for all three doses combined; no clustering of cases was seen after any dose.…”

Section: Surveillancementioning

confidence: 99%

“…41 A total of 151 intussusception cases meeting Brighton Level 1 criteria were identified; of these, 104 were vaccinated with ROTAVAC and 47 were unvaccinated. 41 Attributable risk 1-21 d after the first and second doses (combined) was 0.11 (95% CI: 0.0-0.25) per 100,000 doses, and 0.42 (95% CI: 0.0-.70) per 100,000 doses for all three doses combined; no clustering of cases was seen after any dose. 41 The analysis found no increased risk of intussusception during the first 21 d following any of the three doses of ROTAVAC or all three doses combined, compared to the control period (d 22-365).…”

Section: Surveillancementioning

confidence: 99%

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Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1

Skansberg

Sauer

Tan

et al. 2020

Human Vaccines & Immunotherapeutics

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Rotavirus is the leading cause of severe dehydrating gastroenteritis and death due to diarrhea among children under 5, causing over 180,000 under-5 deaths annually. Safe, effective rotavirus vaccines have been available for over a decade and are used in over 98 countries. In addition to the globally available, WHO-prequalified ROTARIX (GSK) and RotaTeq (Merck), several new rotavirus vaccines have attained national licensure -ROTAVAC (Bharat Biotech) and ROTASIIL (Serum Institute of India), licensed and manufactured in India and now WHO-prequalified, and Rotavin-M1 (PolyVac), licensed and manufactured in Vietnam. In this review, we summarize the available clinical trial and post-introduction evidence for these three new orally administered rotavirus vaccines. All three vaccines have demonstrated safety and efficacy against rotavirus diarrhea, although publicly available preclinical data are limited in some cases. This expanding product landscape presents a range of options to optimize immunization programs, and new presentations of each vaccine are currently under development.

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Profile and Epidemiology of Intussusception in Children Under-Two Years of Age: A Prospective Surveillance

et al. 2021

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

Cited by 11 publications

References 19 publications

Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis

Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis

Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1

Profile and Epidemiology of Intussusception in Children Under-Two Years of Age: A Prospective Surveillance

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