A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data.

BACKGROUND: Intussusception (IS) is a form of acute intestinal obstruction that occurs mainly in infants and is usually of unknown cause. An association between IS and the first licensed rotavirus vaccine, a reassortant-tetravalent, rhesus-based rotavirus vaccine (RRV-TV), led to the withdrawal of the vaccine. New rotavirus vaccines have now been developed and extensively studied for their potential association with IS. This study aimed to describe the epidemiology and to estimate the incidence of IS in Latin American infants prior to new vaccine introduction. METHODS: Children under 2 years of age representing potential IS cases were enrolled in 16 centers in 11 Latin American countries from January 2003 to May 2005. IS cases were classified as definite, probable, possible or suspected as stated on the Brighton Collaboration Working Group guidelines. RESULTS: From 517 potential cases identified, 476 (92%) cases were classified as definite, 21 probable, 10 possible and 10 suspected for intussusception. Among the 476 definite IS cases, the median age at presentation was 6.4 months with 89% of cases aged <1 year. The male to female ratio was 1.5:1. The incidence of definite IS per 100,000 subject-years ranged from 1.9 in Brazil to 62.4 in Argentina for children <2 years of age, and from 3.8 in Brazil to 105.3 in Argentina for children aged <1 year. Median hospital stay was 4 days with a high prevalence of surgery as the primary treatment (65%). Most cases (88%) made a complete recovery, but 13 (3%) died. No clear seasonal pattern of IS cases emerged. CONCLUSIONS: This study describes the epidemiology and estimates the incidence of IS in Latin American infants prior to the introduction of new rotavirus vaccines. The incidence of IS was found to vary between different countries, as observed in previous studies. TRIAL REGISTRATION: Clinical study identifier 999910/204 (SERO-EPI-IS-204).

Cost-effectiveness analysis measuring the total costs against the health benefits of three different rotavirus vaccines for Mexico.

Rotavirus (RV) infection causes acute rotavirus gastroenteritis (RVGE) in infants. Safe and effective RV vaccines are available, of which Mexico has included one in its national immunization program (NIP) since 2007. Health outcome gains, expressed in quality-adjusted life years (QALYs), and cost improvements are important additional factors for the selection of a NIP vaccine. These two factors were analyzed here for Mexico over one year implementing three RV vaccines: 2-dose Rotarix (HRV), versus 3-dose RotaTeq (HBRV), and 3-dose Rotasiil (BRV-PV), presented in a 1-dose or 2-dose vial). HRV would annually result in discounted QALY gains of 263 extra years compared with the other vaccines by averting an extra 24,022 homecare cases, 10,779 medical visits, 392 hospitalizations, and 12 deaths. From a payer's perspective and compared with HRV, BRV-PV 2-dose vial and BRV-PV 1-dose vial would annually result in $13,548,179 and $4,633,957 net savings, respectively, while HBRV would result in $3,403,309 extra costs. The societal perspective may also show savings compared with HRV for BRV-PV 2-dose vial of $4,875,860, while BRV-PV 1-dose vial and HBRV may show extra costs of $4,038,363 and $12,075,629 respectively. HRV and HBRV were both approved in Mexico, with HRV requiring less investment than HBRV with higher QALY gains and cost savings. The HRV vaccine produced those higher health gains due to its earlier protection and greater coverage achieved after its schedule completion with two doses only, providing full protection at four months of age instead of longer periods for the other vaccines.

Rotavirus (RV) infection causes acute diarrhea in infants and can be life-threatening. Several safe and effective vaccines against RV and its complications exist. For many governments choosing vaccines for national immunization programs, total costs or savings and health gains are important factors in the selection process. We compared the costs and health benefits of three RV vaccines for Mexico: HRV, HBRV, and BRV-PV, that have different dosing schedules: two doses for HRV and three doses for HBRV and BRV-PV. HRV is currently part of the national immunization program in Mexico. HRV would result in more health benefits as it incurs fewer RV-related cases, medical visits, hospitalizations, and infant deaths than the other vaccines due to its early protection achieved after only two doses to complete its schedule. However, from a payer's perspective, the least expensive vaccine was BRV-PV, while HRV was less expensive than HBRV. From a societal perspective, also accounting for families' costs and loss in income due to an infant's RV disease, and the families' costs and loss in income when accompanying the infant to the vaccination center, the HRV vaccine was less expensive than HBRV and BRV-PV presented in a 1-dose vial, while more expensive than BRV-PV presented in a 2-dose vial. HRV and HBRV are both approved in Mexico, although HBRV requires a greater investment at lower health benefits than HRV, from both a payer's and a societal perspective. A 2-dose vaccination scheme is an important asset for the economic value of this vaccination program.

Human caliciviruses detected in Mexican children admitted to hospital during 1998-2000, with severe acute gastroenteritis not due to other enteropathogens.

Few studies exist regarding the frequency of human caliciviruses as single etiologic agents in sporadic cases, or in outbreaks occurring in children hospitalized for acute gastroenteritis. In this study, a total of 1,129 children of <5 years of age and hospitalized due to acute diarrhea were enrolled from three main hospitals in Mexico City during a period of 3 years (March 1998 to December 2000). After analyzing all fecal samples for several enteropathogens, 396 stools that remained negative were further screened for human caliciviruses by RT-PCR using a primer set specific to norovirus and sapovirus. Human caliciviruses were detected in 5.6% (22/396) of the children. The minimum incidence rate for 1999 were 5.3% (7/132) for 1999 and 7.8% (13/167) for 2000, since only fecal specimens that tested negative to other enteric pathogens were examined. Positive samples were further characterized using specific GI and GII primers and sequencing. Norovirus GII was detected in 19/22 samples, most of them were GII/4, while sapovirus GI/2 was detected in one sample. Associations between the presence of human calicivirus and clinical and epidemiological data revealed that diarrhea occurred with a seasonal pattern, and that children hospitalized due to human calicivirus disease scored an average of 13 +/- 3.2 (SD) points on the Vesikari scale, which corresponded to severe episodes. These results highlight that human caliciviruses, by themselves, are enteropathogens of acute severe diarrhea among young Mexican children requiring hospitalization and that their detection is important in order to reduce the diagnosis gap.

Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study.

BACKGROUND: Peak incidence of rotavirus gastroenteritis is seen in infants between 6 and 24 months of age. We therefore aimed to assess the 2-year efficacy and safety of an oral live attenuated human rotavirus vaccine for prevention of severe gastroenteritis in infants. METHODS: 15 183 healthy infants aged 6-13 weeks from ten Latin American countries randomly assigned in a 1 to 1 ratio to receive two oral doses of RIX4414 or placebo at about 2 and 4 months of age in a double-blind, placebo-controlled phase III study were followed up until about 2 years of age. Primary endpoint was vaccine efficacy from 2 weeks after dose two until 1 year of age. Treatment allocation was concealed from investigators and parents of participating infants. Efficacy follow-up for gastroenteritis episodes was undertaken from 2 weeks after dose two until about 2 years of age. Analysis was according to protocol. This study is registered with ClinicalTrials.gov, number NCT00140673 (eTrack444563-023). FINDINGS: 897 infants were excluded from the according-to-protocol analysis. Fewer cases (p<0.0001) of severe rotavirus gastroenteritis were recorded for the combined 2-year period in the RIX4414 group (32 [0.4%] of 7205; 95% CI 0.3-0.6) than in the placebo group (161 [2.3%] of 7081; 1.9-2.6), resulting in a vaccine efficacy of 80.5% (71.3-87.1) to 82.1% (64.6-91.9) against wild-type G1, 77.5% (64.7-86.2) against pooled non-G1 strains, and 80.5% (67.9-88.8) against pooled non-G1 P[8] strains. Vaccine efficacy for hospital admission for rotavirus gastroenteritis was 83.0% (73.1-89.7) and for admission for diarrhoea of any cause was 39.3% (29.1-48.1). No cases of intussusception were reported during the second year of follow-up. INTERPRETATION: Two doses of RIX4414 were effective against severe rotavirus gastroenteritis during the first 2 years of life in a Latin American setting. Inclusion of RIX4414 in routine paediatric immunisations should reduce the burden of rotavirus gastroenteritis worldwide.

Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.

BACKGROUND: The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. METHODS: We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients). RESULTS: The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78). CONCLUSIONS: Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

Protective effects of natural rotavirus infection.

Rotavirus is a ubiquitous infection that is the leading cause of severe diarrhea worldwide. Severe infections are most commonly observed in the first 2 years of life. Rotavirus-induced diarrhea is associated with substantial morbidity and mortality rates and socioeconomic costs with adverse outcomes particularly prevalent in developing countries. The natural history of rotavirus infection can provide guidance for the development and optimization of an effective vaccine. Epidemiologic studies have demonstrated that children who acquire natural rotavirus infections develop immunity to subsequent infections, with the protective effect increasing with each natural infection. Natural infections also decrease the severity of any subsequent rotavirus infections. Notably, asymptomatic infections provide protection similar to that induced by symptomatic infections. Data also suggest that the antibody response to natural infection is heterotypic, and therefore may provide protection against multiple serotypes. These data suggest that the development of a vaccine that produces asymptomatic infection at an optimal time point may provide effective immunity. An effective vaccine should mimic protection provided by natural infection and provide protection against the most common rotavirus serotypes (ie, G1, G2, G3, G4, G9) and be able to decrease disease severity, reduce hospitalizations, and decrease disease-related costs.

Risk of Intussusception After Rotavirus Vaccination: Meta-analysis of Postlicensure Studies.

BACKGROUND: Postlicensure surveillance studies suggest a small temporal increase in the risk for intussusception with both currently available rotavirus vaccines (RV1; Rotarix, GSK and RV5; RotaTeq, Merck & Co., Inc.). This meta-analysis was undertaken to provide a single overall estimate of the relative risk of intussusception during the 7-day period after administration of RV1 and RV5. METHODS: Meta-analysis based on estimates of relative risk and corresponding 95% confidence intervals from 5 postlicensure studies providing an estimate of risk of intussusception during the 7-day period after administration of dose 1 and/or dose 2 of RV1 and/or RV5, based on active and/or passive surveillance, for confirmed intussusception cases (Brighton or other method of case confirmation). For each vaccine, the relative risk of intussusception was estimated postdose 1 and postdose 2. Results were pooled using the inverse variance method using both fixed-effect and random-effect models. RESULTS: The overall estimate of relative risk of intussusception during the 7 days postdose 1 was 5.4 (95% confidence interval: 3.9-7.4, 3 studies) for RV1 and 5.5 (3.3-9.3, 3 studies) for RV5. The overall estimate of relative risk of intussusception during the 7 days postdose 2 was 1.8 (1.3-2.5, 4 studies) for RV1 and 1.7 (1.1-2.6, 3 studies) for RV5. CONCLUSIONS: This meta-analysis showed a similar increased risk of intussusception, during the first 7 days after administration of dose 1 and, to a lesser extent, dose 2, for both currently available rotavirus vaccines. This suggests that intussusception may be a class effect of currently available oral rotavirus vaccines.

Natural rotavirus infection is not associated to intussusception in Mexican children.

AIMS: To determine whether natural rotavirus infection or infection by another enteropathogen is associated to intussusception (IS); and to describe the seasonality of IS compared with severe diarrhea (SD) and rotavirus SD in Mexican children. METHODS: A prospective, observational, multicenter and case-control study was conducted in Mexico City from December 1999 to February 2001. Cases were children younger than 1 year old hospitalized for IS; diagnosis was made by clinical features, radiologic and/or surgery findings. Controls were children younger than 1 year old hospitalized for another disease than a gastrointestinal illness (NGI). Cases and controls were paired by age and date of admission (+/-3 months; for both), in a 1:2 ratio. A surveillance of IS cases, SD and rotavirus SD episodes was conducted during the study period. Stool samples collected soon after IS resolution or at admission were tested for rotavirus, adenovirus, astrovirus, bacteria and parasites. RESULTS: Thirty cases of IS and 60 controls with NGI were studied. Rotavirus was not detected in any case of IS. Adenovirus (17%) was the only enteropathogen detected in IS. Rotavirus (8%), adenovirus (2%), astrovirus (2%) and bacteria (2%) were detected in NGI. Rotavirus infection was not associated with IS (odds ratio, 0; 95% confidence interval, 0-2.9), whereas adenovirus infection was strongly associated as risk factor for IS (odds ratio undefined; P = 0.003), compared with NGI. Seasonal variation in admissions for IS was small, whereas admissions for SD and rotavirus SD showed a marked seasonal increase during fall-winter. CONCLUSIONS: In Mexican children, rotavirus infection was not associated to IS; whereas a significant association was observed between adenovirus and IS. Also there was no increase in IS cases during the sharply defined fall-winter rotavirus outbreak. Observations from this controlled study suggest that natural rotavirus infection is not a risk factor for IS. This information may have implications for development of a safer and effective rotavirus vaccine.

Diarrhea morbidity and mortality in Mexican children: impact of rotavirus disease.

AIM: To analyze changes in prevalence and seasonality of diarrhea morbidity and mortality and to evaluate the impact of rotavirus disease among Mexican children younger than 5 years old. METHODS: Diarrhea surveillance was performed from 1990 to 2002. Rotavirus testing was performed on stool specimens from 1996 to 2002. Data were obtained from different surveillance systems considering a nationwide representation in Mexico. Diarrhea morbidity and mortality rates were analyzed against time to determine trends or seasonal patterns. RESULTS: Improvement of surveillance for all diarrhea episodes denoted an initial morbidity increase from 1995 to 1999, followed by a decrease by 2002, without any seasonal pattern. However, from 1990 to 1995, morbidity for severe diarrhea decreased 63%. From 1996 to 2002, 62-68% of severe diarrhea episodes occurring during the fall-winter season (FWS) were rotavirus-positive compared with 6-12% in the spring-summer season (SSS). From 1990 to 2002, diarrhea mortality decreased 84%. Higher mortality rates for children younger than 1 year old coincided precisely during the FWS, annually. Both severe diarrhea episodes and diarrhea deaths denoted a changing seasonal pattern. In 1990-1991, 2 waves of increased diarrhea activity occurred. The increase in SSS was much more pronounced than that in FWS. From 1992 to 1995 for severe diarrhea and from 1993 to 2002 for diarrhea deaths, the SSS frequencies subsequently reduced, whereas the FWS peaks remained annually. CONCLUSIONS: A significant reduction in morbidity and mortality of severe diarrhea has occurred from 1990 and 2002 in Mexican children younger than 5 years old. This is a consequence of preventive programs initiated for cholera control since 1991, which had greater impact on SSS diarrhea and limited response for FWS diarrhea, when rotavirus is mainly present. Currently rotavirus diarrhea requires new prevention strategies and specific control measures, such as a specific national vaccine program.

Evaluation of the second generation of a commercial latex agglutination test for the detection of rotavirus antigens in fecal samples.

BACKGROUND: Despite vaccine availability, the infection rate and disease burden associated with rotavirus infection are still high. Thus, accurate diagnosis of rotavirus infection continues to be necessary for proper patient clinical management and disease control. OBJECTIVE: To evaluate the performance of a novel, second generation, commercial latex tests (Pastorex™ Rotavirus latex agglutination test, BIORAD, Marnes-La-Coquette, France), for the detection of rotavirus in human feces. STUDY DESIGN: Using 166 fecal samples collected from children with acute diarrhea, and previously tested for rotavirus, calicivirus and astrovirus, the second generation Pastorex™ Rotavirus latex agglutination test was evaluated. RESULTS AND CONCLUSION: The test showed a sensitivity of 85.9% and a specificity of 97.7%. Positive and negative predicted values for the test were 97% and 88%, respectively. The results suggest that this commercial test is a good alternative for rotavirus diagnosis.

Impact of rotavirus vaccination on hospitalisations in Belgium: comparing model predictions with observed data.

BACKGROUND: Published economic assessments of rotavirus vaccination typically use modelling, mainly static Markov cohort models with birth cohorts followed up to the age of 5 years. Rotavirus vaccination has now been available for several years in some countries, and data have been collected to evaluate the real-world impact of vaccination on rotavirus hospitalisations. This study compared the economic impact of vaccination between model estimates and observed data on disease-specific hospitalisation reductions in a country for which both modelled and observed datasets exist (Belgium). METHODS: A previously published Markov cohort model estimated the impact of rotavirus vaccination on the number of rotavirus hospitalisations in children aged <5 years in Belgium using vaccine efficacy data from clinical development trials. Data on the number of rotavirus-positive gastroenteritis hospitalisations in children aged <5 years between 1 June 2004 and 31 May 2006 (pre-vaccination study period) or 1 June 2007 to 31 May 2010 (post-vaccination study period) were analysed from nine hospitals in Belgium and compared with the modelled estimates. RESULTS: The model predicted a smaller decrease in hospitalisations over time, mainly explained by two factors. First, the observed data indicated indirect vaccine protection in children too old or too young for vaccination. This herd effect is difficult to capture in static Markov cohort models and therefore was not included in the model. Second, the model included a 'waning' effect, i.e. reduced vaccine effectiveness over time. The observed data suggested this waning effect did not occur during that period, and so the model systematically underestimated vaccine effectiveness during the first 4 years after vaccine implementation. CONCLUSIONS: Model predictions underestimated the direct medical economic value of rotavirus vaccination during the first 4 years of vaccination by approximately 10% when assessing hospitalisation rates as compared with observed data in Belgium.

Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico.

BACKGROUND: Mexico initiated mass vaccination with the attenuated human rotavirus vaccine (Rotarix) in 2006. This postlicensure study aimed to assess any potential temporal association between vaccination and intussusception in Mexican infants. METHODS: Prospective, active surveillance for intussusception among infants aged less than 1 year was conducted in 221 hospitals across Mexico from the Mexican Institute of Social Security between January 2008 and October 2010. The temporal association between vaccination and intussusception was assessed by self-controlled case-series analysis. RESULTS: Of the 753 episodes of intussusception reported in 750 infants, 701 were in vaccinated infants (34.5% post-dose 1, 65.5% post-dose 2). The relative incidence of intussusception within 31 days of vaccination was 1.75 (95.5% confidence interval [CI]: 1.24-2.48; P=0.001) post-dose 1 and 1.06 (95.5% CI: 0.75-1.48; P=0.75) post-dose 2. The relative incidence of intussusception within 7 days of vaccination was 6.49 post-dose 1 (95.5% CI: 4.17-10.09; P<0.001) and 1.29 post-dose 2 (95.5% CI: 0.80-2.11; P=0.29). Clustering of intussusception within 7 days of vaccination was observed post-dose 1. An attributable risk of 3 to 4 additional cases of intussusception per 100,000 vaccinated infants was estimated. CONCLUSION: This is the largest surveillance study for intussusception after rotavirus vaccination to date. A temporal increase in the risk for intussusception was seen within 7 days of administration of the first vaccine dose. It is still uncertain whether rotavirus vaccination has any impact on the overall incidence of intussusception. This finding has to be put in perspective with the well-documented substantial benefits of rotavirus vaccination.

Burden of disease and costs of treating rotavirus diarrhea in Mexican children for the period 2001-2006.

OBJECTIVES: To estimate the health impact and the costs of treatment associated with rotavirus diarrhea in six yearly cohorts (2001-2006) of Mexican infants. METHODS: The perspective of study is from the health care system. We estimated the effect of rotavirus diarrhea on disability adjusted life years (DALYS) and diarrhea treatment costs in hypothetical cohorts of infants who are followed from birth up to five years of age beginning in years from 2001 to 2006. We used information from administrative databases on mortality and health care from the National System of Information on Health and from the Mexican Institute for Social Security to feed a decision analysis to project the burden of disease and costs of treatment. RESULTS: Estimates of DALYS were 19,426 in 2001 and decreased by 28.9% for 2006 meanwhile costs of treatment were relatively constant, estimated at US$ 38.7 million and increased only by 5%. CONCLUSION: Rotavirus diarrhea in Mexican children is a major disease burden, presenting significant treatment costs. Rotavirus diarrhea mortality is decreasing; however this has not led to a steady decrease in treatment costs in the 6 years period of analysis. A sensitivity analysis showed that incidences of rotavirus diarrhea as well as the parameters associated with health-care access were the main factors, which had a significant effect on the projected burden of disease and costs.

Economic impact of a rotavirus vaccination program in Mexico.

OBJECTIVES: To evaluate the cost and benefits of a national rotavirus childhood vaccination program in Mexico. METHODS: A decision-analysis model was designed to take the Mexican health care system's perspective on a comparison of two alternatives: to vaccinate against rotavirus or not. Using published, national data, estimations were calculated for the rotavirus illnesses, deaths, and disability-adjusted life years (DALYs) that would be averted and the incremental cost-effectiveness ratios (US$/DALY) of a hypothetical annual birth cohort of 2 285 000 children, with certain assumptions made for cost, coverage, and efficacy rates. RESULTS: With 93% coverage and a vaccine price of US$ 16 per course (2 doses), a rotavirus vaccination program in Mexico would prevent an estimated 651 deaths (or 0.28 deaths per 1 000 children); 13 833 hospitalizations (6.05 hospitalizations per 1 000 children); and 414 927 outpatient visits (182 outpatient visits per 1 000 children) for rotavirus-related acute gastroenteritis (AGE). Vaccination is likely to reduce the economic burden of rotavirus AGE in Mexico by averting US$ 14 million (71% of the overall health care burden). At a vaccine price of US$ 16 per course, the cost-effectiveness ratio would be US$ 1 139 per DALY averted. A reduction in the price of the rotavirus vaccination program (US$ 8 per course) would yield a lower incremental cost-effectiveness ratio of US$ 303 per DALY averted. CONCLUSIONS: A national rotavirus vaccination program in Mexico is projected to reduce childhood incidence and mortality and to be highly cost-effective based on the World Health Organization's thresholds for cost-effective interventions.

Economic impact of a rotavirus vaccination program in Mexico / Impacto económico de un programa de vacunación contra rotavirus en México

OBJECTIVES: To evaluate the cost and benefits of a national rotavirus childhood vaccination program in Mexico. METHODS: A decision-analysis model was designed to take the Mexican health care system's perspective on a comparison of two alternatives: to vaccinate against rotavirus or not. Using published, national data, estimations were calculated for the rotavirus illnesses, deaths, and disability-adjusted life years (DALYs) that would be averted and the incremental costeffectiveness ratios (US$/DALY) of a hypothetical annual birth cohort of 2 285 000 children, with certain assumptions made for cost, coverage, and efficacy rates. RESULTS: With 93 percent coverage and a vaccine price of US$ 16 per course (2 doses), a rotavirus vaccination program in Mexico would prevent an estimated 651 deaths (or 0.28 deaths per 1 000 children); 13 833 hospitalizations (6.05 hospitalizations per 1 000 children); and 414 927 outpatient visits (182 outpatient visits per 1 000 children) for rotavirus-related acute gastroenteritis (AGE). Vaccination is likely to reduce the economic burden of rotavirus AGE in Mexico by averting US$ 14 million (71 percent of the overall health care burden). At a vaccine price of US$ 16 per course, the cost-effectiveness ratio would be US$ 1 139 per DALY averted. A reduction in the price of the rotavirus vaccination program (US$ 8 per course) would yield a lower incremental cost-effectiveness ratio of US$ 303 per DALY averted. CONCLUSIONS: A national rotavirus vaccination program in Mexico is projected to reduce childhood incidence and mortality and to be highly cost-effective based on the World Health Organization's thresholds for cost-effective interventions.

OBJETIVOS: Evaluar el costo y los beneficios de un programa nacional de vacunación infantil contra el rotavirus en México. MÉTODOS: Se diseñó un modelo de análisis de decisión, desde la perspectiva del sistema de salud mexicano, para comparar dos alternativas: vacunar contra el rotavirus o no vacunar. A partir de datos nacionales publicados se estimó el número de casos y muertes por rotavirus, los años de vida ajustados por la discapacidad (AVAD) que se evitarían y la relación costo-efectividad incremental (US$/AVAD) de una cohorte anual hipotética de 2 285 000 niños; se partió de algunos supuestos sobre el costo, la cobertura y las tasas de eficacia. RESULTADOS: Con una cobertura de 93 por ciento y un precio de la vacuna de US$ 16,00 por esquema (dos dosis), se estima que un programa de vacunación contra rotavirus en México evitaría 651 muertes (0,28 muertes por 1 000 niños), 13 833 hospitalizaciones (6,05 hospitalizaciones por 1 000 niños) y 414 927 visitas de consulta externa (182 consultas por 1 000 niños) por gastroenteritis aguda asociada a rotavirus (GAR). La vacunación podría reducir la carga económica por GAR en México al evitar gastos por US$ 14 millones (71 por ciento de la carga total por atención sanitaria). A un precio de US$ 16,00 por esquema, la relación costo-efectividad sería de US$ 1 139,00 por AVAD evitado. Una reducción en el precio del programa de vacunación contra rotavirus (US $8,00 por esquema) generaría una menor relación costo-efectividad incremental de US$ 303,00 por AVAD evitado. CONCLUSIONES: Un programa nacional de vacunación contra rotavirus en México reduciría la incidencia y la mortalidad infantiles y sería altamente efectivo en función del costo, según los umbrales de las intervenciones de costo-efectividad de la Organización Mundial de la Salud.

Single multiplex polymerase chain reaction to detect diverse loci associated with diarrheagenic Escherichia coli.

We developed and tested a single multiplex polymerase chain reaction (PCR) that detects enterotoxigenic, enteropathogenic, enteroinvasive, and Shiga toxin-producing Escherichia coli. This PCR is specific, sensitive, and rapid in detecting target isolates in stool and food. Because of its simplicity, economy, and efficiency, this protocol warrants further evaluation in large, prospective studies of polymicrobial substances.