Objectives: To review the potential benefits of pediatric combination vaccines to children, parents, providers, managed care organizations, and manufacturers and to discuss the scientific, social, and economic issues that need to be addressed to provide optimum uptake of these vaccines.
Results: Combination vaccines provide multiple advantages for children, parents, and providers; however, their development involves considerable research and expense to ensure efficacy and safety. As the complexity of these vaccines increases, more extensive laboratory and clinical trials will be needed to ensure antigen compatibility, immunogenicity, and acceptable reactogenicity. To accommodate the large numbers of subjects necessary to establish vaccine efficacy and the absence of rare severe adverse events, revision of future licensure requirements may be necessary. Cost-benefit studies will be helpful in guiding pricing levels for manufacturers, efficient purchase plans for providers, and appropriate reimbursement policies for managed care organizations.
Conclusions: The continued development and introduction of new combination vaccines offers significant potential benefits. Optimal uptake will require careful review of their many advantages and attention to potential problems perceived by those who will be affected by their use: manufacturers, children, parents, providers, and payers.