Vaccines, Immunology and Clinical Trials

Biomarkers and Case Reports

Vaccines prevent infectious diseases, but vaccination is not without risk and adverse events are reported although they are more commonly reported for biologicals than for vaccines. Vaccines and biologicals must undergo a rigorous assessment before and after licensure to minimize safety concerns. Potential safety concerns should be identified as early as possible during the development of vaccines and biologicals to minimize investment risk. State-of-the-art tools and methods to identify safety concerns and biomarkers that are predictive of clinical outcomes are indispensable. For vaccines and adjuvant formulations, systems biology approaches, supported by single-cell microfluidics applied to translational studies between preclinical and clinical studies, could improve reactogenicity and safety predictions.