. 2018 Apr 19;378(16):1521-1528.

doi: 10.1056/NEJMoa1713909.

Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa

Jacqueline E Tate¹, Jason M Mwenda¹, George Armah¹, Bhavin Jani¹, Richard Omore¹, Ayesheshem Ademe¹, Hilda Mujuru¹, Evans Mpabalwani¹, Bagrey Ngwira¹, Margaret M Cortese¹, Richard Mihigo¹, Hope Glover-Addy¹, Mwajabu Mbaga¹, Francis Osawa¹, Amezene Tadesse¹, Bothwell Mbuwayesango¹, Julia Simwaka¹, Nigel Cunliffe¹, Benjamin A Lopman¹, Goitom Weldegebriel¹, Daniel Ansong¹, David Msuya¹, Billy Ogwel¹, Thomas Karengera¹, Portia Manangazira¹, Bruce Bvulani¹, Catherine Yen¹, Felicitas R Zawaira¹, Clement T Narh¹, Lazaro Mboma¹, Peter Saula¹, Fasil Teshager¹, Halle Getachew¹, Rebecca M Moeti¹, Christabel Eweronu-Laryea¹, Umesh D Parashar¹; African Intussusception Surveillance Network

Collaborators, Affiliations

Collaborators

Affiliation

¹ From the Centers for Disease Control and Prevention, Atlanta (J.E.T., M.M.C., B.A.L., C.Y., H.G., U.D.P.); the World Health Organization (WHO) Regional Office for Africa, Brazzaville, Republic of Congo (J.M.M., R.M., F.R.Z., R.M.M.); the Noguchi Memorial Institute for Medical Research (G.A.) and the School of Medicine and Dentistry, College of Health Sciences (C.E.-L.), University of Ghana, and Korle Bu Teaching Hospital (H.G.-A.), Accra, Komfo Anokye Teaching Hospital, Kumasi (D.A.), and the School of Public Health, University of Health and Allied Sciences, Hohoe (C.T.N.) - all in Ghana; the WHO Country Office (B.J.) and Muhimbili National Hospital (M.M.), Dar es Salaam, Kilimanjaro Christian Medical Center, Moshi (D.M.), and Mbeya Zonal Referral Hospital, Mbeya (L.M.) - all in Tanzania; Kenya Medical Research Institute, Center for Global Health Research, Kisumu (R.O., B.O.), the Department of Surgery, School of Medicine, University of Nairobi, Nairobi (F.O.), and the School of Medicine, Moi University, Eldoret (P.S.) - all in Kenya; the WHO Country Office (A.A., T.K., F.T.) and the School of Medicine, Addis Ababa University (A.T.), Addis Ababa, Ethiopia; Harare Central Hospital (H.M., B.M.), the Department of Pediatrics and Child Health, University of Zimbabwe (H.M.), the WHO Intercountry Support Team (G.W.), and Epidemiology and Disease Control, Ministry of Health and Child Care (P.M.), Harare, Zimbabwe; the Children's Hospital (E.M.), Adult Hospital, Virology Laboratory (J.S.), and Adult Hospital, Department of Surgery, Pediatric Surgical Unit (B.B.), University Teaching Hospitals, Lusaka, Zambia; the College of Medicine, University of Malawi, Blantyre (B.N.); and the Centre for Global Vaccine Research, Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom (N.C.).

PMID: 29669224
PMCID: PMC11748062
DOI: 10.1056/NEJMoa1713909

Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa

Jacqueline E Tate et al. N Engl J Med. 2018.

. 2018 Apr 19;378(16):1521-1528.

doi: 10.1056/NEJMoa1713909.

Authors

Collaborators

Affiliation

¹ From the Centers for Disease Control and Prevention, Atlanta (J.E.T., M.M.C., B.A.L., C.Y., H.G., U.D.P.); the World Health Organization (WHO) Regional Office for Africa, Brazzaville, Republic of Congo (J.M.M., R.M., F.R.Z., R.M.M.); the Noguchi Memorial Institute for Medical Research (G.A.) and the School of Medicine and Dentistry, College of Health Sciences (C.E.-L.), University of Ghana, and Korle Bu Teaching Hospital (H.G.-A.), Accra, Komfo Anokye Teaching Hospital, Kumasi (D.A.), and the School of Public Health, University of Health and Allied Sciences, Hohoe (C.T.N.) - all in Ghana; the WHO Country Office (B.J.) and Muhimbili National Hospital (M.M.), Dar es Salaam, Kilimanjaro Christian Medical Center, Moshi (D.M.), and Mbeya Zonal Referral Hospital, Mbeya (L.M.) - all in Tanzania; Kenya Medical Research Institute, Center for Global Health Research, Kisumu (R.O., B.O.), the Department of Surgery, School of Medicine, University of Nairobi, Nairobi (F.O.), and the School of Medicine, Moi University, Eldoret (P.S.) - all in Kenya; the WHO Country Office (A.A., T.K., F.T.) and the School of Medicine, Addis Ababa University (A.T.), Addis Ababa, Ethiopia; Harare Central Hospital (H.M., B.M.), the Department of Pediatrics and Child Health, University of Zimbabwe (H.M.), the WHO Intercountry Support Team (G.W.), and Epidemiology and Disease Control, Ministry of Health and Child Care (P.M.), Harare, Zimbabwe; the Children's Hospital (E.M.), Adult Hospital, Virology Laboratory (J.S.), and Adult Hospital, Department of Surgery, Pediatric Surgical Unit (B.B.), University Teaching Hospitals, Lusaka, Zambia; the College of Medicine, University of Malawi, Blantyre (B.N.); and the Centre for Global Vaccine Research, Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom (N.C.).

PMID: 29669224
PMCID: PMC11748062
DOI: 10.1056/NEJMoa1713909

Abstract

Background: Postlicensure evaluations have identified an association between rotavirus vaccination and intussusception in several high- and middle-income countries. We assessed the association between monovalent human rotavirus vaccine and intussusception in lower-income sub-Saharan African countries.

Methods: Using active surveillance, we enrolled patients from seven countries (Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe) who had intussusception that met international (Brighton Collaboration level 1) criteria. Rotavirus vaccination status was confirmed by review of the vaccine card or clinic records. The risk of intussusception within 1 to 7 days and 8 to 21 days after vaccination among infants 28 to 245 days of age was assessed by means of the self-controlled case-series method.

Results: Data on 717 infants who had intussusception and confirmed vaccination status were analyzed. One case occurred in the 1 to 7 days after dose 1, and 6 cases occurred in the 8 to 21 days after dose 1. Five cases and 16 cases occurred in the 1 to 7 days and 8 to 21 days, respectively, after dose 2. The risk of intussusception in the 1 to 7 days after dose 1 was not higher than the background risk of intussusception (relative incidence [i.e., the incidence during the risk window vs. all other times], 0.25; 95% confidence interval [CI], <0.001 to 1.16); findings were similar for the 1 to 7 days after dose 2 (relative incidence, 0.76; 95% CI, 0.16 to 1.87). In addition, the risk of intussusception in the 8 to 21 days or 1 to 21 days after either dose was not found to be higher than the background risk.

Conclusions: The risk of intussusception after administration of monovalent human rotavirus vaccine was not higher than the background risk of intussusception in seven lower-income sub-Saharan African countries. (Funded by the GAVI Alliance through the CDC Foundation.).

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Figures

**Figure 1.**
Number of intussusception cases by age at symptom onset and number of doses of rotavirus vaccine administered by age, African Intussusception Surveillance Network, February 2012-December 2016

**Figure 2.**
Distribution of intussusception cases in the 60 days following the first and second doses of monovalent rotavirus vaccine, African Intussusception Surveillance Network, February 2012-December 2016

See this image and copyright information in PMC

Comment in

Intussusception after Rotavirus Vaccination in Africa.
Elmakki E. Elmakki E. N Engl J Med. 2018 Sep 27;379(13):1288. doi: 10.1056/NEJMc1807645. N Engl J Med. 2018. PMID: 30260600 No abstract available.

References

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Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa

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Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa

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