OBJECTIVES: Evaluate sistematically the studies of budget impact analysis (BIA) of vaccines in relation to the methodology. METHODS: A systematic review of literature was performed in the following databases: MedLine, Embase, Virtual Health Library (BVS), Cochrane Library and Centre for Reviews and Dissemination. The time of publication was not limited. After the search, the studies have gone through some steps: reading the title/abstract, reading the full text, data extraction and quality assessment. Inclusion criteria were budget impact analysis in vaccines. Two reviewers worked independently on the steps os review with reconciliation mettings. Disagreement cases were resolved arbitrarily or through a third reviewer. RESULTS: Of the 218 studies identified in the search in databases, 22 were included in the systematic review. Most studies (59%) were performed in Europe, 54,5% carried another economic evaluation in addition to the BIA, and half were cost-effectiveness analysis and 68,2% had industry funding. The pneumococcal vaccine was the most representative, with 40,9%, followed by influenza (22,7%), rotavirus (18,2%), Tdap (4,5%), HIV (4,5%), hexavalent (4,5%) and HPV (4,5%). Relative to the methodology, we realized the absence of important items in some studies, for an economic analysis, such as time horizon, perspective of analysis and conclusion related to BIA, and for the vaccines, such as number of doses, efficacy/effectiveness data and vaccine coverage. CONCLUSIONS: With the systematic review possible to observe that the BIA have some gaps related to methodology, whether in regard to economic analysis or vaccines. Thus, we realized the need for discussions on the development of guidelines for BIA witch eventually will lead to an improvement of quality of the studies methodologies.