Regulations and procedures in parasite vaccine development.
Although immunisation protocols for a wide variety of parasitic diseases have been developed, it is often questioned why these do not always reach the market. In this review information about the regulations and procedures that apply to licensing the production and marketing of medicinal preparations, especially parasite vaccines, is presented. These general regulations specify issues on product (quality, safety, efficacy and potency) and production (facilities and consistency). Vaccine developers and manufacturers have to comply with these regulations, which may involve years of research and development. Moreover, where the manufacturer claims specific features of the product, these claims have to be corroborated by (experimental) data. A series of principles has been used to develop vaccines against parasite infections varying from the use of (attenuated) live vaccines to killed vaccines and subunit vaccines. The implications of some specific regulatory issues associated with these approaches are discussed.
Schetters
Th P M
TP
Parasitology R&D Department, Intervet International, P.O. Box 31, 5830 AA, Boxmeer, The Netherlands. theo.schetters@intervet.com
Gravendyck
M
M
D000818:Animals; D005062:European Union; D019317:Evidence-Based Medicine; D006801:Humans; D016052:Protozoan Vaccines; D011786:Quality Control; D012106:Research; D012449:Safety; D016896:Treatment Outcome; D014481:United States; D014611:Vaccination / Q000331:legislation & jurisprudence* / Q000379:methods*; D014613:Vaccines, Attenuated
D016052:Protozoan Vaccines; D014613:Vaccines, Attenuated