Stability Studies of Vaccines

Abstract

Edward Jenner laid the foundation of vaccination as he was the first to introduce and use the procedure as well as pursued his scientific investigation against the deadly smallpox. Due to his work and the recent advancements in science, now the world claims that smallpox has been eradicated from the world. For long-lasting effective immunization, both the humoral- and cell-mediated parts of the adaptive immunity need to be stimulated. There are almost seven types of vaccines that are currently in use or in the stage of development. The benefit-risk profile (efficacy) of each vaccine is constantly evaluated during the entire process right from the individual component pre-clinical evaluation (in vitro and in vivo) and clinical (human trial) and developmental phase till the end use. The Vaccine Adverse Event Reporting System (VAERS) used by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) monitors post-licensure vaccine efficacy and safety using various methods and techniques. Advanced kinetic models are used to calculate the degradation kinetics rate of biological products such as protein and virus-based vaccines and also an emulsion-based adjuvant vaccine. Statistical tools are used to select an optimal number based on the variable parameters used for fitting of experimental data obtained from different steps of kinetic models.