title: Which pharmacovigilance for vaccines?
abstract: Vaccines are not separate health products but anti-infectious medicines administered for the large part prophylactically and for which the effect is immunological and not pharmacological. They should be evaluated by the usual methods of clinical pharmacology and pharmacovigilance, taking into account certain specificities (mechanism of action, manufacture, frequent administration to healthy subjects, particular recommendations, etc.). Experience from some vaccination campaigns have revealed insufficiencies notably in data collection allowing evaluation of the interest of a vaccine to public health, its relevance to the recent epidemiology of the disease in question and long-term security. The absence of data can generate fear in the general population that is broadcast by anti-vaccination lobby. For a more optimal pharmacovigilance of vaccines, it is necessary to: (i) improve the coherence between the evaluating authorities; (ii) set up, in addition to the usual risk management plan, an active microbiological and epidemiological surveillance and to follow up exposed populations; (iii) have programmes of education of the medical community regarding vaccination and health education for the general public.
authors.affiliation: Service de Pharmacologie, Hôpital Henri Mondor, Paris, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Louët
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Loupi
authors.forename: Françoise
authors.initials: F
authors.lastname: Haramburu
mesh_terms: D003625:Data Collection; D004345:Drug Industry / Q000592:standards; D004501:Education, Medical; D006266:Health Education; D006801:Humans; D011159:Population Surveillance; D011358:Product Surveillance, Postmarketing; D012308:Risk Management; D014612:Vaccines / Q000009:adverse effects* / Q000592:standards