Intussusception Risk: Rotavirus Vaccination in Mexico and Brazil

New England Journal of Medicine
June 16, 2011  Vol. 364 No. 24
http://content.nejm.org/current.shtml

Original Article
Intussusception Risk and Health Benefits of Rotavirus Vaccination in Mexico and Brazil
Manish M. Patel, Vesta Richardson López-Collada, Marília Mattos Bulhões, Lucia Helena De Oliveira, Aurora Bautista Márquez, Brendan Flannery, Marcelino Esparza-Aguilar, Ernesto Isaac Montenegro Renoiner, María Edilia Luna-Cruz, Helena Keico Sato, Luz del Carmen Hernández-Hernández, Gerardo Toledo-Cortina, Magdalena Cerón-Rodríguez, Neydi Osnaya-Romero, Mario Martínez-Alcazar, Rocío Gabriela Aguinaga-Villasenor, Arturo Plascencia-Hernández, Francisco Fojaco-González, Guillermo Hernández-Peredo Rezk, Sixto Fortino Gutierrez-Ramírez, Roberto Dorame-Castillo, Rogelio Tinajero-Pizano, Bernice Mercado-Villegas, Marilia Reichelt Barbosa, Eliane Mara Cesário Maluf, Lucimar Bozza Ferreira, Francisca Maria de Carvalho, Ana Rosa dos Santos, Eduardo Dolabella Cesar, Maria Elisa Paula de Oliveira, Carmem Lúcia Osterno Silva, Maria de los Angeles Cortes, Cuauhtemoc Ruiz Matus, Jacqueline Tate, Paul Gargiullo, and Umesh D. Parashar
N Engl J Med 2011; 364:2283-2292June 16, 2011

Background
Because postlicensure surveillance determined that a previous rotavirus vaccine, RotaShield, caused intussusception in 1 of every 10,000 recipients, we assessed the association of the new monovalent rotavirus vaccine (RV1) with intussusception after routine immunization of infants in Mexico and Brazil.
Full Text of Background…

Methods
We used case-series and case–control methods to assess the association between RV1 and intussusception. Infants with intussusception were identified through active surveillance at 69 hospitals (16 in Mexico and 53 in Brazil), and age-matched infants from the same neighborhood were enrolled as controls. Vaccination dates were verified by a review of vaccination cards or clinic records.
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Results
We enrolled 615 case patients (285 in Mexico and 330 in Brazil) and 2050 controls. An increased risk of intussusception 1 to 7 days after the first dose of RV1 was identified among infants in Mexico with the use of both the case-series method (incidence ratio, 5.3; 95% confidence interval [CI], 3.0 to 9.3) and the case–control method (odds ratio, 5.8; 95% CI, 2.6 to 13.0). No significant risk was found after the first dose among infants in Brazil, but an increased risk, albeit smaller than that seen after the first dose in Mexico — an increase by a factor of 1.9 to 2.6 — was seen 1 to 7 days after the second dose. A combined annual excess of 96 cases of intussusception in Mexico (approximately 1 per 51,000 infants) and in Brazil (approximately 1 per 68,000 infants) and of 5 deaths due to intussusception was attributable to RV1. However, RV1 prevented approximately 80,000 hospitalizations and 1300 deaths from diarrhea each year in these two countries.
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Conclusions
RV1 was associated with a short-term risk of intussusception in approximately 1 of every 51,000 to 68,000 vaccinated infants. The absolute number of deaths and hospitalizations averted because of vaccination far exceeded the number of intussusception cases that may have been associated with vaccination. (Funded in part by the GAVI Alliance and the U.S. Department of Health and Human Services.)
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