CHAPTER 4

• Jurisdiction: United States

CHAPTER 4 EXPERIMENTATION STAGES FOR A VACCINE¹

It may be helpful, as one studies the claim of an unexpected injury from a product, to ask how the product was tested before it reached the market. Preclinical evaluation of the experimental vaccine looks at its injection-site reactions and examines a toxicological profile in animal models like mice or rabbits to determine how the vaccine works in a living system.² The animal models provide some safety insights for the experimentation team. Then brave human patients can participate in the next phase, the human clinical trial stages, at which human safety and human health benefits are established.

At Phase I, the vaccine science team seeks to determine the safety profile, pharmacokinetics, and pharmacologic information. Initial administration of the test vaccine to human...