From the laboratory microfuge tube to animals and then to clinical trials. Overall, this section explains what it takes to develop a new vaccine. The process begins in the laboratory. After candidate vaccine is developed in the laboratory it is first tested in both animals and in additional laboratory trials to determine if it has the appropriate properties including safety, immune response, and where possible, protection against tuberculosis. Next, the vaccine will be evaluated in humans in a series of defined steps.
The process of vaccine evaluation has been carefully defined. It proceeds in several phases - from the bench, through animals, into the field, and through the approval process.