Objective: To present the evaluation framework supporting the clinical, epidemiological and impact studies to introduce the new Cuban conjugated pneumococcal vaccine in the national vaccination program.
Methods: The design of the evaluation strategy of the new vaccine in the Cuban included: the revision of the scientific evidence available in literature, the definition of the evaluation objectives, the application of conceptual and methodological evaluation frame, the performance of the process to generate the new scientific evidences about the new vaccine. The regulatory frame for the evaluation and introduction of new PCVs were taken into consideration during the whole process.
Results: The background of licensed pneumococcal vaccine with similarly based studies was synthetized. The evaluation strategy of the Cuban vaccine was presented in terms of objectives, key processes, and main components (context evaluation, generation of evidence for making-decisions, introduction of the new vaccine and impact evaluation). The procedures to collect information and analysis of the new evidence generated on PCV7-TT are defined (characterize the study problem, the functioning of the new vaccine, and cost-effectiveness and impact). The evaluation strategy is operationalized in the Cuban context, where preschool children and infants are defined as target population. The contributions, strengths and weaknesses in the evaluation design and in the generation of evidences are discussed.
Conclusions: The rigorous scientific evidences generated by the implementation evaluation strategies, applied to the new Cuban conjugated pneumococcal vaccine will allow the decision-making for its introduction to national health system in Cuba.