OBJECTIVES: Pneumococcal (Pnc) disease represents a major healthcare concern being associated with severe complications. Scope of this study was to evaluate the budgetary impact effect of providing vaccination with seven-valent pneumococcal conjugate vaccine (PCV) to newborns in Lombardy (Italy). METHODS: Budget impact analysis was applied to the 2004 cohort of newborns of Lombardy: efficacy data as number of pneumonia and acute otitis media (AOM) cases, and consumption of resources were derived from a large multicenter single-blind clinical study (results published) of vaccinated versus unvaccinated Italian children. Vaccinated children were administered 3 doses of PCV at 3, 5 and 11 months of age; Pnc morbidity was recorded until the 30th month of age. Economic analysis was performed in the perspective of the third party payer, considering direct costs (vaccine doses, administration costs, drugs, visits and hospitalisations for management of Pnc disease complications); unit cost of resources (2006 values) was retrieved from national reimbursement tariff lists and other published sources. RESULTS: The cost of vaccination was calculated as €133/patient; cost of pneumonia and AOM were calculated as €2258 and €31 per case. Vaccination of the whole newborns population of Lombardy would avoid about 6700 cases of AOM and 2700 cases of pneumonia. The economic effect of vaccination would be a net saving, ranging from €million 1.0 to 0.8 and 0.5 for respectively 100%, 80% and 50% vaccination coverage. These savings may be underestimated when considering the economic effects on cases of meningitis, the extension of vaccination benefits after the second year of age in the vaccinated infants and the effect of herd immunity on total population. CONCLUSION: Our analysis suggests that the use of PCV in infants is likely to be economically justified due to savings from pneumonia and AOM cases averted, in the population of newborns of Lombardy.