Pharmacogenomics in the Evaluation of Efficacy and Adverse Events During Clinical Development of Vaccines

Abstract

The understanding of vaccine-induced immune responses in adults and infants is limited. Current vaccination schedules for infants are frequently debated. Especially, the relationship among the timing, the frequency of the dosing, and the generation of an immunological memory are debated. Vaccine antigen-induced cytokine responses to vaccinations given in infancy are of particular interest because little is known about cellular responses in this age, and the information available is based on antibody responses. Pharmacogenomics is ideally suited to study cellular responses related to immune response; in addition, toxicity, inflammation, apoptosis, stress, and oncogenesis can be monitored, since the expression of thousands of genes can be measured in a single experiment.

Pharmacogenetics in Europe: Barriers and Opportunities

“…Companies might therefore use patent rights to block the development of diagnostics. On the other hand, some pharmacogenomic tests offer the potential to reduce the costs of clinical trials by pre-identifying patients who might experience adverse drug reactions (ADRs) [38, 39]. In such cases large pharmaceutical companies may choose to pursue the development of relevant diagnostic tests themselves or turn to the expertise of smaller diagnostic firms.…”

Application Of Pharmacogenomics To Vaccines

“…Others have commented that ‘Knowledge that a trait of interest has high heritability can support a study that proposes to investigate the genetic determinants of that trait’ [61]. It is important to note that the unique genetic and environmental characteristics of different individuals and vaccines demand a clear understanding of the role of critical aspects of vaccine pharmacogenomics [11,62]. …”