Strategies for the Nonclinical Safety Assessment of Vaccines

Over the past century, vaccines have made a large impact on public health. Prophylactic vaccines prevent disability and disease, saving millions of dollars in potential health-care spending. Since prophylactic vaccines are administered to healthy individuals, including infants and children, it is important to demonstrate the safety of vaccines preclinically prior to testing the vaccine in clinical studies. A benefit-to-risk profile is considered for each individual vaccine and depends on many factors including preclinical and clinical toxicities that are observed, frequency of administration and intended target population. For prophylactic vaccines, in particular, the concerns about potential risks often outweigh the perception of benefit [1]. Therefore, over the past decade, there has been an increased focus on nonclinical safety assessment of vaccines, including toxicity testing.