Safety and Effectiveness of Rotavirus Vaccine in Children Under Five Years Old: A Systematic Review and Meta-Analysis

Rotavirus is the most common cause of diarrhea in children worldwide. Vaccination of children has a very important effect in reducing diarrheal infection. This study was conducted to determine the safety and effectiveness of a rotavirus vaccine in children.

This study was a systematic review and meta-analysis, the data bases searched being Iranmedex, Nirp, SID, Web of science, Scopus, CRD, Pubmed, Magiran, Cochrane, and Google scholar search engine between 2000 and 2019. The inclusion criteria were children under 5 years of age, interventions with the rotavirus vaccines, Rota Teq or RV1 or RV5 or RRV or RRVTV or Rotarix or RIX-4414, compared with placebo or no vaccine. All the intervention studies were, after evaluating the quality of the methodology, included in the study. The total final effect was estimated by estimating the standard error and the ratio through meta-analysis using a random model method, followed by calculating the vaccine effectiveness. The publication bias of the studies was evaluated using the relevant tests.

A total of 767 related articles were searched by systematic review, followed by studying the full texts of 61 articles and screening 18 based on the consequences resulting from reduced visits, reduced hospitalizations and deaths, and selecting finally six studies. The overall efficiencies of the Rotateq vaccine and Rotarix were estimated, based on the standard error index and the efficacy ratio index, to be 94% and 79%, respectively, and the risk ratio (case group to the control group) was 23.81-41.96.

The findings of this study confirm the high effectiveness of the rotavirus vaccine in reducing rotavirus diarrhea. This means that the economic burden attributable to this disease will be significantly reduced.