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Effect of Rotavirus Vaccination on Death from Childhood Diarrhea in Mexico

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Effect of Rotavirus Vaccination on Death from Childhood Diarrhea in Mexico The new england journal of medicine original article Effect of Rotavirus Vaccination on Death from Childhood Diarrhea in Mexico Vesta Richardson, M.D., Joselito Hernandez-Pichardo, M.D., Manjari Quintanar-Solares, M.D., Marcelino Esparza-Aguilar, M.D., Brian Johnson, B.S., Cesar Misael Gomez-Altamirano, M.D., Umesh Parashar, M.D., M.P.H., and Manish Patel, M.D. Abstract Background A phased introduction of a monovalent rotavirus vaccine occurred in Mexico from From the National Center for Child and February 2006 through May 2007. We assessed the effect of vaccination on deaths Adolescent Health, Ministry of Health, Mexico City (V.R., J.H.-P., M.Q.-S., M.E.-A., from diarrhea in Mexican children in 2008 and 2009. C.M.G.-A.); and the National Center for Immunization and Respiratory Diseases, Methods Centers for Disease Control and Preven- tion, Atlanta (B.J., U.P., M.P.). Address re- We obtained data on deaths from diarrhea, regardless of cause, from January 2003 print requests to Dr. Patel at the Centers through May 2009 in Mexican children under 5 years of age. We compared diarrhea- for Disease Control and Prevention, 1600 related mortality in 2008 and during the 2008 and 2009 rotavirus seasons with the Clifton Rd., MS A-47, Atlanta, GA 30333, or at [email protected]. mortality at baseline (2003–2006), before the introduction of the rotavirus vaccine. Vaccine coverage was estimated from administrative data. N Engl J Med 2010;362:299-305. Copyright © 2010 Massachusetts Medical Society. Results By December 2007, an estimated 74% of children who were 11 months of age or younger had received one dose of rotavirus vaccine. In 2008, there were 1118 diarrhea- related deaths among children younger than 5 years of age, a reduction of 675 from the annual median of 1793 deaths during the 2003–2006 period. Diarrhea-related mortality fell from an annual median of 18.1 deaths per 100,000 children at base- line to 11.8 per 100,000 children in 2008 (rate reduction, 35%; 95% confidence inter- val [CI], 29 to 39; P<0.001). Among infants who were 11 months of age or younger, diarrhea-related mortality fell from 61.5 deaths per 100,000 children at baseline to 36.0 per 100,000 children in 2008 (rate reduction, 41%; 95% CI, 36 to 47; P<0.001). As compared with baseline, diarrhea-related mortality was 29% lower for children between the ages of 12 and 23 months, few of whom were age-eligible for vaccina- tion. Mortality among unvaccinated children between the ages of 24 and 59 months was not significantly reduced. The reduction in the number of diarrhea-related deaths persisted through two full rotavirus seasons (2008 and 2009). Conclusions After the introduction of a rotavirus vaccine, a significant decline in diarrhea-related deaths among Mexican children was observed, suggesting a potential benefit from rotavirus vaccination. n engl j med 362;4 nejm.org january 28, 2010 299 Downloaded from www.nejm.org at INSTITUT CATALA DE LA SALUT on May 3, 2010 . Copyright © 2010 Massachusetts Medical Society. All rights reserved. The new england journal of medicine espite the improved safety of food, tained by one of three health care institutions: water, and sanitation and the aggressive the Ministry of Health through the National Cen- Dpromotion of noninvasive interventions ter for Child and Adolescent Health (CENSIA) (e.g., oral rehydration therapy) and prevention purchases vaccine for 50% of Mexican infants; strategies (e.g., increased breast-feeding), diarrhea Instituto Mexicano del Seguro Social (IMSS) pur- remains the second leading infectious cause of chases vaccine for all workers and their families, childhood death worldwide, accounting for ap- constituting approximately 43% of the Mexican proximately 1.8 million annual deaths in children population; and Instituto de Seguridad y Servicios under 5 years of age.1 Rotavirus is the single Sociales de los Trabajadores del Estado (ISSSTE) most important cause of severe childhood diar- purchases vaccine for all federal employees, rep- rhea globally and annually causes more than half resenting approximately 7% of the population. In a million deaths among children under 5 years of February 2006, the Ministry of Health introduced age.2,3 In a large clinical trial conducted in Latin the monovalent rotavirus vaccine in impoverished America, the monovalent human rotavirus vaccine regions of selected states in Mexico, accounting Rotarix (GlaxoSmithKline Biologicals) showed a for less than 5% of the Mexican birth cohort. In protective efficacy of 85% against severe rotavi- November 2006, the vaccine was also made avail- rus disease and of 42% against severe diarrhea able for children who were insured through the from any cause.4-7 On the basis of these encour- IMSS, and in May 2007, the Ministry of Health aging data, several countries in the Americas be- extended the program to include all Mexican chil- gan including a rotavirus vaccine in their routine dren born after February 1, 2007. It was recom- childhood immunization program in 2006.8,9 mended that infants receive two doses of vaccine, In Mexico, substantial reductions in diarrhea- at 2 and 4 months of age. related deaths and complications occurred from 1990 to 2002 as a result of improved sanitation Vaccine Coverage Data and safe water, the promotion of breast-feeding There were no surveys of rotavirus vaccine cover- and oral rehydration, and supplementation with a age during the years of our study. However, as the megadose of vitamin A.10-12 These measures have supplier of vaccine for half of Mexican infants, reduced the number of diarrhea-related deaths CENSIA maintains administrative coverage data occurring in the spring and summer months for this population. Thus, we assessed vaccina- that were attributable to bacterial pathogens, but tion coverage data available through CENSIA for deaths during the fall and winter months, when this cohort of children. CENSIA, which purchases the prevalence of rotavirus is increased, have per- and distributes the vaccine to the states, uses an sisted.10 Because of the persistent burden of electronic registration system through which the diarrhea-related deaths and hospitalizations from Mexican states (territorial jurisdictions and health rotavirus, in 2006, Mexico became one of the centers) report on the number of vaccine doses first countries worldwide to introduce the mono- that have been administered (either one or two valent rotavirus vaccine in its national immuni- doses for the rotavirus vaccine). The recording and zation program. reporting of doses generally follow the recommen- Because prelicensure trials did not assess the dations of the World Health Organization (WHO). effect of rotavirus vaccination on mortality from At the local level, clinic workers maintain a diarrhea, the assessment of whether the use of tally sheet for the number of administered vac- these vaccines will prevent diarrhea-related death cine doses. A supervisor is responsible for check- is a high public health priority.13 In this study, ing the quality of the data at the local level. Each we examined trends in diarrhea-related deaths month, the clinics report to the state the num- among Mexican children before and after the in- ber of doses that have been administered. State troduction of rotavirus vaccination and correlat- health workers subsequently transmit the aggre- ed these trends with data on vaccine coverage. gated data to CENSIA. We used the administra- tive method to assess rates of vaccine coverage.14 Methods The administrative method provides a crude esti- mate of coverage, which equals the annual num- Population ber of doses administered, divided by the birth Mexico has an annual birth cohort of 1.9 million cohort that is eligible to receive vaccine pur- infants. In Mexico, vaccines for children are ob- chased through CENSIA. 300 n engl j med 362;4 nejm.org january 28, 2010 Downloaded from www.nejm.org at INSTITUT CATALA DE LA SALUT on May 3, 2010 . Copyright © 2010 Massachusetts Medical Society. All rights reserved. Effect of Rotavirus Vaccine on Death from Childhood Diarrhea We calculated rotavirus vaccine coverage among Results children who were 11 months of age or younger and among those between the ages of 12 and 23 Vaccine Coverage months at the end of 2007. A determination of On the basis of CENSIA data, before the 2008 vaccine coverage according to age at the end of rotavirus season, 826,112 first doses and 565,797 2007 allowed us to estimate the number of chil- second doses of monovalent rotavirus vaccine were dren who potentially would be protected from administered in a target population that included severe rotavirus disease during 2008. 1.12 million infants who were 11 months of age or younger, for an overall vaccine coverage of 74% Diarrhea-Related Deaths for the first dose and 51% for the second dose. For the period from January 2003 through May Approximately 69,600 of the total doses (5%) 2009, we obtained data on diarrhea-related deaths were administered during 2006 in selected im- among Mexican children from the National In- poverished regions of 14 Mexican states. Because stitute of Statistics, Geography, and Informatics infants in these regions constitute less than 5% and the Ministry of Health’s General Directorate of the overall birth cohort in Mexico, it was un- of Health Information, which collates all infor- likely that the vaccine program would have a major mation from death certificates for children under effect on the rate of diarrhea-related death nation- 5 years of age. Data were accessed through the wide. In addition, before the 2008 rotavirus sea- National System for Health Information.15 From son, CENSIA vaccine coverage was low among these data, we abstracted information on diar- children between 12 and 23 months of age, with rhea-related deaths, using the following codes an estimated coverage of 4% for the first dose from the International Classification of Diseases, 10th and 2% for the second dose in January 2008.
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