Quelle PharmacoVigilance pour les vaccins ?

Abstract

Vaccines are drugs. Like all medicines, they are submitted to pre-clinical tests and then clinical trials. These tests and trials are essential but unfortunately insufficient because, for example, they are necessarily too short, they include too few subjects not representative of future treated patients... These points underline, once again, the importance for both patients and their doctors of the pharmacovigilance after marketing authorization. Phar- macovigilance of vaccines involves first, like all other medicines, the reporting of adverse drug reactions to the regional pharmacovigilance centers. For vaccines, it can be first spontaneous (i.e. not solicited or passive) and sought (encouraged active, as did for the HIN vaccine) involving not only health professionals but also the whole population (patients, relatives... ). Spontaneous reporting remains the only methodfor an early warning detection. The pharmacoepidemiological methods (case-control, cohort studies, expected- observed method, Self Controlled Cases-Series...) are secondarily used to confirm or deny a signal suggested by spontaneous notifications. More than elsewhere, these studies are also needed to quantify the populational risk. Pharmacovigilance is essential for a modern, clinical and medical evaluation of the benefit of vaccine. Knowledge of vaccine pharmaco- vigilance data also allows to recall the excellent benefits harms balance of these drugs, much higher than that of many other drug classes.