Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização

Abstract

The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials".Articles focusing on specifi c adverse events were excluded.The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity.The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.

Prevalência e fatores associados à ocorrência de eventos adversos pós-vacinação em crianças

“…(1,2,12,13) Immunization coverage rates in Brazil are considered high, especially in relation to children, granting the country global recognition regarding immunization actions, considered an important measure of social coverage. (1,14) The high frequency of AEFI in children under one year old found in this study was also evidenced in other studies. (7,8,15) This study points out that in this age group there is a higher concentration of vaccines applied and the immune system is still immature, increasing the probability of infectious processes, allergies, and clinical alterations that may be associated with immunization.…”

“…(7,8,15) This study points out that in this age group there is a higher concentration of vaccines applied and the immune system is still immature, increasing the probability of infectious processes, allergies, and clinical alterations that may be associated with immunization. (13,14,16,17) The present study evidenced the predominance of AEFI in children aged between 3 and 6 months. Six of the fifteen vaccine doses are recommended for children under one year old.…”

Ocorrência De Eventos Adversos Pós-Vacinação Em Idosos

“…Embora o percentual de DVA identificado neste estudo esteja abaixo do estimado pelo PNI, este evento adverso requer vigilância rigorosa, devido a sua gravidade e alta letalidade em idosos (21) . A vacina FA também causou EAPV não grave, com percentuais superiores aos referidos pelo PNI(9), provavelmente pelo aumento da sensibilidade da vigilância epidemiológica (22) . Apesar de o abscesso subcutâneo quente ter apresentado baixa frequência, a sua ocorrência é preocupante porque indica desvio da qualidade, que interfere na segurança do paciente e origina erro de imunização, evento evitável que pode causar ou levar a um uso inapropriado de imunobiológicos, ou causar dano a um paciente, enquanto o produto está sob o controle de profissionais de saúde (9) .…”

National immunization program: vaccination, compliance and pharmacovigilance

“…The early, honest and efficient communication of the results of one investigation assure the integrity of immunization programs 11 .…”