The use of prevention of colonization as a biologically functional endpoint makes clinical field assessments (phase

III or IV) smaller, less costly, faster and technically feasible in a wide variety of locations. Therefore it can be used to assess not only new vaccine formulations but also address vaccine dosage and schedules relevant to check details the local vaccination programs. We also argue that it is a critical method for documenting PCV impact at the individual and community level following introduction into the routine immunization programs of countries; although it is not a disease endpoint in itself, where IPD surveillance is limited or not possible, colonization impact reveals the biologic impact of the vaccine on the organism and by bridging to other data where both IPD and colonization have been assessed, will allow for inferences about disease impact. Therefore, the learn more specific PneumoCarr project goals were to (1) develop the use of vaccine efficacy against pneumococcal nasopharyngeal

colonization (VE-colonization) as part of the regulatory licensure process, and (2) determine recommendations for how to optimally use NP colonization evaluations to inform the impact of PCV vaccines for public health purposes. The project objectives to meet these goals were to (1) develop the scientific basis and analytic why tools for pneumococcal colonization studies as a supportive strategy for licensure, and (2) develop and support the technical community understanding and acceptance of pneumococcal colonization as an approach to licensure of novel pneumococcal vaccines. These two objectives address the key obstacles

to use of VE-colonization as a strategy for the development, licensure and implementation of new pneumococcal vaccine products. An international consultation “Workshop to explore the role of carriage studies in the evaluation and licensing of new pneumococcal vaccines”, co-sponsored by WHO and PneumoCarr, was convened at WHO in Geneva, Switzerland, in March 2012 to provide vaccine manufacturers and regulators the opportunity to understand and comment on the “Case for Carriage, C4C” document, a PneumoCarr white paper that presents the justification for the inclusion of VE-col in pneumococcal vaccine licensure pathway.