OnthewaytoImplementationofVaccinationProgramsMyths.pptVIP

Clinical trials rely entirely upon the participation of volunteers. 97 A vaccine usually goes through three phases of clinical trials before it can be licensed for public use. 97,98 Phase I trials involve about 20 to 80 healthy adult subjects and are used to ascertain whether the product has any major toxicity problems. Phase I trials also allow the manufacturer to collect some safety and immunogenicity data on dose-related immune responses. 97,98 Phase II trials use larger numbers of subjects (100 to 200), as well as controls. These trials further evaluate product safety and provide preliminaryinformation on dosing and efficacy. 97,98 Phase III trials use several hundred to thousands of subjects to confirm safety and efficacy. They may also provide information that will be included in the package insert and support approval by the regulatory bodies. 97,98 Phase IV trials may be conducted following licensure of the vaccine in an attempt to detect reactions that may not have been observed in Phase I–III clinical trials.97,98 [Ref 97: Baylor, p 1545] [Ref 97: Baylor, p 1545] [Ref 98: NIAID, p 16] [Ref 97: Baylor, p 1545] [Ref 98: NIAID, p 16] [Ref 97: Baylor, p 1545] [Ref 98: NIAID, p 16] [Ref 97: Baylor, p 1547] [Ref 98: NIAID, p 16] [Ref 97: Baylor, p 1548] [Ref 98: NIAID, p 16] [Ref 97: Baylor, p 1545-1548] [Ref 98: NIAID, p 16] This graph shows the typical evolution of an immunization program.98 Stage One: There is a high level of morbidity and mortality due to the disease and a vaccine is, therefore, developed.98 Stage Two: Disease decreases as an effective vaccine begins to be used in thepopulation. More people get vaccinated and the disease incidence goes down even more. Even if a vaccine adverse reaction is extremely rare, it will be seen more “frequently” as the vaccine is used in millions of people.98 Stage Three: Over time, the perceived threat of the disease will decrease, and reports of adverse events will increase and receive gre