Abstract

Vaccine evaluation studies, based on surveillance data, provide rigorous evidence on the population impact. Beyond the traditional clinical trials, these studies should be part of the evaluation strategy from its conception. Cuba has still not introduced a pneumococcal vaccination; thus a high priority has been given to the development and evaluation of a new heptavalent conjugate vaccine candidate (PCV7-T), which is currently in an advanced phase of clinical evaluation. This paper puts into perspective the value of surveillance and evaluation studies to quantify the effects and impact of the introduction and use of pneumococcal vaccination on invasive and non-invasive disease rates and nasopharyngeal colonisation (carrier status) in infants and pre-school children. The surveillance studies and the ongoing evaluation studies, as well as the main results of the former, are described. The methodological and operational challenges are also addressed. All these elements will contribute to the body of evidence that will support the decision-making on the introduction of the new Cuban vaccine in the National Vaccination Program, and will form the basis for the evaluation of the health impact of the infant population after the introduction of the pneumococcal vaccine in Cuba.

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