Healthy Skepticism Library item: 12162

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Le Louët H, Loupi E, Haramburu F; Round Table No 3, Giens XXII.
Which pharmacovigilance for vaccines?
Therapie 2007 May-Jun; 62:(3):241-7
http://www.journal-therapie.org/index.php?option=article&access=doi&doi=10.2515/therapie:2007039

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.

Keywords:
Data Collection Drug Industry/standards Education, Medical Health Education Humans Population Surveillance Product Surveillance, Postmarketing* Risk Management Vaccines/adverse effects* Vaccines/standards