Formal regulation began with vaccine testing, and in response to tragedies associated with vaccine use, more comprehensive regulatory procedures began to be defined.11
In the United States of America, the country with the longest history in vaccine regulation, 20 children became ill and 14 died in 1901 following receipt of an equine-derivedEquine-derivedA substance extracted from horses, e.g. some antibodies used in passive immunization are extracted from the serum of horses exposed to the target antigen. diphtheriaDiphtheriaA disease caused by toxigenic strains of Corynebacterium diphtheriae. Often marked by the formation of a false membrane in the throat, diphtheria is a serious vaccine-preventable disease that can cause death in unvaccinated children. antitoxin contaminated with tetanusTetanusA disease caused primarily by toxigenic C. tetani. The rare but often fatal disease affects the central nervous system by causing painful muscular contractions. toxin.
This event stimulated the first legislation to regulate the sale of biologicalsBiologicalsA medical product prepared from biologic material of human, animal, or microbiologic origin (e.g., blood products, vaccines, insulin)., the Biologics Control Act, signed into law in 1902.12
Today vaccine regulation includes a range of measures — legal, administrative and technical — that governments take to ensure the vaccines' safety, efficacy and quality. They can vary from country to country, both in scope and implementation, but generally include at least the following functions:
- licensing the manufacture, import, export, distribution, promotion and advertising of vaccines;
- assessing the safety, efficacy and quality of vaccines, and issuing marketing authorization;
- inspecting, and conducting surveillance of, manufacturers, importers, wholesalers and dispensers of vaccines;
- controlling and monitoring the quality of vaccines existing on the market;
- controlling the promotion and advertising of vaccines;
- monitoring adverse reactions related to the vaccines in use;
- providing independent information on vaccines to the professionals and the public.
Progress in vaccine regulation globally includes shifts towards strictly defined procedures for vaccine consistency, reliance on Good Manufacturing Practices (GMPs) rather than final product testing and continued vaccine pharmacovigilance and impact surveillanceSurveillanceThe systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis, to gain knowledge of the pattern of disease occurrence and potential in a community, in order to control and prevent disease in the community. rather than individual, sporadic field studies.