Estrategia y resultados de la farmacovigilancia de vacunas desde el Instituto Finlay, 2009.

This paper aims at showing the strategy and the results of pharmacosurveillance at Finlay Institute, as owner of sanitary medical registries. The biography of products was consolidated in post-marketing stage and risk/benefit balance was examined. In our case, the spontaneous notification of adverse events and the compliance with good practices and rules/regulations of the regulatory authority was possible due to agreements with institutions that allowed the access to digital and auditable data bases. Data-mining search of the grouping of rare and unexpected events for a same lot or accidents, the preparation of periodic safety reports and the systematic practice to fill requested information on subpopulations and special groups, allowed updating the safety profile of vaccines. It was confirmed that the frequency of adverse events of trivalent Leptospirosis vaccine, the typhoid Vi vaccine and tetanus toxoid, was lower than 0.1 report per every 100 000 vaccinees, while the other vaccines showed values from 0.1 to 1 per 100 000 vaccinees. From 80% to 95% of the notifications were causally related to the vaccine, and only 0.89% was of serious severity, almost all of it in children younger than one year. General manifestations were predominant. Results showed the pertinence of industry pharmacosurveillance to obtain valuable safety information on vaccine administration. [ABSTRACT FROM AUTHOR]