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By Dean L. Winslow, MD, FACP, FIDSA
Professor of Medicine, Division of General Medical Disciplines, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine
Dr. Winslow reports no financial relationships relevant to this field of study.
SYNOPSIS: Using active surveillance, researchers enrolled 717 infants with intussusception from sub-Saharan Africa. The risk of intussusception was no higher in those who received the monovalent rotavirus vaccine than in non-immunized infants.
SOURCE: Tate JE, Mwenda JM, Armah G, et al. Evaluation of intussusception after monovalent rotavirus vaccination in Africa. N Engl J Med 2018;378:1521-1528.
Monitoring of intussusception rates was instituted at 29 sentinel hospitals in seven sub-Saharan African countries (Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe) to assess the safety of a newly introduced monovalent rotavirus vaccine (RV1). Patients were enrolled from 2012-2016. Researchers employed standardized criteria for the diagnosis of intussusception and standardized case reporting. The incidence of intussusception was analyzed at days 1-7 (corresponding to peak viral replication), days 8-21, and days 1-21 following RV1 vaccination.
Researchers identified 717 patients with confirmed intussusception following vaccination in children 28-245 days of age. One case occurred in the one- to seven-day time period after dose 1, and six cases occurred in the eight to 21 days after dose 1. Five cases occurred in the one to seven days after dose 2, and 16 cases occurred in the eight to 21 days after dose 2. The relative risk of intussusception was 0.25 following dose 1 and 0.76 following dose 2. The rate was far below the background rate of intussusception.
The initial rotavirus vaccine (RotaShield) was associated with one excess case of intussusception per 10,000 children when first introduced into high- and middle-income countries and was withdrawn from the market.1 Newer monovalent (Rotarix) and pentavalent (RotaTeq) vaccines subsequently were released and, although licensing studies did not show an excess incidence of intussusception associated with the administration of the newer vaccines, post-marketing surveillance suggested one to six excess cases of intussusception per 100,000 immunized children in high- and middle-income countries.2
Little data exist on efficacy and safety of rotavirus vaccine when used in children in the developing world. Since more than half of the childhood deaths due to rotavirus infection occur in sub-Saharan Africa, this large, well-conducted study that did not show excess rates of intussusception should be reassuring and supports the more widespread rollout of rotavirus vaccine in the developing world.
Financial Disclosure: Peer Reviewer Patrick Joseph, MD, is a consultant for Genomic Health Reference Laboratory, Siemens Clinical Laboratory, and CareDx Clinical Laboratory. Infectious Disease Alert’s Editor Stan Deresinski, MD, FACP, FIDSA, Updates Author Carol A. Kemper, MD, FACP, Peer Reviewer Kiran Gajurel, MD, Executive Editor Shelly Morrow Mark, Editor Jonathan Springston, and Editorial Group Manager Terrey L. Hatcher report no financial relationships to this field of study.