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.).
Subject(s)
Intussusception/etiology , Rotavirus Vaccines/adverse effects , Africa South of the Sahara/epidemiology , Female , Humans , Immunization Schedule , Incidence , Infant , Intussusception/epidemiology , Intussusception/mortality , Intussusception/therapy , Male , Risk , Rotavirus Infections/prevention & control , Rotavirus Vaccines/administration & dosage , Time-to-Treatment , Vaccines, Attenuated/administration & dosage , Vaccines, Attenuated/adverse effectsABSTRACT
Introduction: an increasing trend of routine immunization performance has generally been observed over the past decade in Ethiopia. However, inconsistencies were observed over time and among different sources of data. This review analyzed systematically data from various sources and produced regional and national coverage estimates for antigens offered in the infant immunization program in Ethiopia. Methods: we collated data from administrative reports, population-based surveys and other sources to produce annual estimates of vaccination coverage. We obtained relevant data for each of the 9 Regional States and 2 city administrations, for the period 2007-2016. Region level estimates were produced based on survey results, interpolation between or extrapolation. We aggregated the resulting region level estimates, using a population-weighted approach, to give national estimates. Results: we found that the national Penta 3 coverage of Ethiopia increased from 59% in 2007 to 71% in 2016. For the 110 vaccination estimates produced at region level, 71 were based on interpolation or extrapolation from empirical anchor points; 18% were based on surveys and 17% were based on administrative data. Conclusion: while we recognize the critical importance of improving the quality of information on vaccination coverage from administrative reporting systems, we are also cognizant of the expected continued need for region level surveys and improved rapid-monitoring exercises.