Developing a vaccination evaluation model to support evidence-based decision making on national immunization programs

Among all public health provisions national immunization programs (NIPs) are beyond doubt one of the most effective in reducing mortality, morbidity, and costs associated with major infectious diseases. To maintain their success, NIPs have to modernize in response to many new and old demands regarding efficacy, safety, availability of new vaccines, emerging and evolving pathogens, waning immunity, altered epidemiological situations, and the public's trust in the program. In this paper we present an evaluation model in the form of a checklist that may help in collecting relevant scientific information that is necessary for evaluation and decision making when considering changes in a NIP. Such a checklist points to relevant information on the vaccine-preventable disease, the pathogen causing it, the vaccine, and the cost-effectiveness ratio of the vaccine. However, the final judgment on a potential change in the NIP cannot be based on a simple algorithm, as the relevant information reflects factors of a very different kind and magnitude, to which different value judgements may be added, and which may have certain degrees of uncertainty. Because any change in the NIP may be accompanied by more or less unforeseen changes in the vaccine's efficacy, evolutionary consequences, including the antigenic composition of the pathogen, and the vaccine's safety profile, an intensive surveillance program should accompany any NIP. Elements thereof include clinical-epidemiological surveillance, surveillance of vaccination coverage, immune surveillance, surveillance of microbial population dynamics, and surveillance of adverse events and safety issues. We emphasize that the decision to introduce a vaccine in the NIP should be taken as seriously, both scientifically and ethically, as the decision to withhold a vaccine from the NIP. In the latter case one might be responsible for vaccine-preventable disease and mortality.     

Immunohistochemical evaluation of cartilage-derived morphogenic protein-1 and -2 in normal human salivary glands and pleomorphic adenomas

Cartilage-derived morphogenic protein (CDMP)-1 and -2 belong to the bone morphogenetic protein (BMP) family in the transforming growth factor (TGF)-beta superfamily. CDMP-1 and CDMP-2 were reported to play essential roles in limb cartilage and limb-joint formation in developing mice. Although pleomorphic adenoma of the salivary glands is an epithelial tumor, it frequently shows ectopic cartilaginous formation. These findings suggested that CDMP-1 and -2 may play essential roles in chondroid formation in salivary pleomorphic adenoma. To evaluate this hypothesis, we examined the expression and localization of CDMP-1 and -2 immunohistochemically in 20 normal human salivary glands and 35 pleomorphic adenomas. CDMP-1 was immunolocalized in the striated ducts and the intercalated ducts in the normal salivary glands. CDMP-1 was immunolocalized in the cuboidal neoplastic myoepithelial cells around the chondroid areas of the pleomorphic adenomas, whereas these molecules were not localized in the spindle-shaped neoplastic myoepithelial cells of the myxoid element or the lacuna cells of the chondroid element in these tumors. CDMP-2 was expressed neither in normal salivary glands nor any of the elements of the pleomorphic adenomas. Type-II collagen and aggrecan were immunolocalized throughout the matrix around the lacuna cells of the chondroid element, whereas type-X collagen was not immunolocalized in any epithelial or stromal elements, including the chondroid elements. Aggrecan was deposited not only on the chondroid matrix, but also on the myxoid stroma and intercellular spaces of the tubulo-glandular structures, whereas chondromodulin-I was deposited on the chondroid matrix. These results indicated that the cuboidal neoplastic myoepithelial cells around the chondroid areas expressed CDMP-1 and suggested that this molecule may play a role in the differentiation of neoplastic myoepithelial cells in pleomorphic adenoma. The phenotype of the lacuna cells was similar to that of mature to upper hypertrophic chondrocytes of the authentic cartilage. In conclusion, pleomorphic adenoma expressed CDMP-1 but not CDMP-2.