Incidência de episódios hipotônicos-hiporresponsivos associados à vacina combinada DTP/Hib usada no Programa Nacional de Imunizações

Abstract

Objective: To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonichyporesponsive episodes.Method: Follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only. Results:The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine. Conclusion:The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.J Pediatr (Rio J). 2007;83(6):523-528: Active surveillance, hypotonic-hyporesponsive episodes, DTwP/Hib vaccine, safety.

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

“…Another simple alternative was adopted in an area in the city of Rio de Janeiro, Southeastern Brazil, to evaluate severe adverse effects following DPwT/Hib vaccination after the inclusion of this vaccine in routine use in 2002.This program studied a cohort of children enrolled in 16 primary health care units.These units were part of the municipal health care network of the city of Rio de Janeiro, and therefore comprised a very well-defi ned population. 76 A more complex active SAEFI strategy is the analysis of information from cohorts of individuals within delimited areas or areas covered by the same health care providers.These providers have large databases consisting of electronic patient fi les (EPFs) linked to electronic immunization registries (EIRs). 20 The data stored in these databases include information on vaccination, intercurrent clinical events, and other data on the target population.Real-time data entry reduces underreporting and recall bias 24 and allows for more precise denominators to be obtained for risk estimation.…”

“…76,106 Given their recent implementation, and the fact that such systems are not yet adopted in most countries, 36 there is very little knowledge of the SAEFI's goals, strategies, and requirements in terms of adaptation to the peculiarities of health care systems in different countries.The aim of the present review was analyze certain conceptual and operational aspects of SAEFI systems.…”

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

“…Ignorance of the population may undermine reliability on the product and immunization coverage, as observed in relation to the influenza vaccine in 2012. (20,21) In view of the above, the present study suggests the improvement of surveillance actions in relation to AEFI, accuracy in completing the notification form, and continuous education in health services in order to update professionals working in immunization rooms and guide the population on the theme to increase the reliability, quality, and safety of immunization. (1,2,22) …”

“…Most cases are reported in children under two years old. (1,20) Regarding the outcome of the AEFI, the course in most cases was the contraindication with change in the vaccine schedule, especially related to the tetravalent and pentavalent vaccines. In most cases the intensity of the AEFI was considered non-severe and the progress consisted in cure without sequelae.…”

Avaliação do sistema brasileiro de vigilância de eventos adversos pós-vacinação

“…The introduction of the combined diphtheria-tetanus-whole-cell pertussis and Haemophilus influenzae type b (DTwP/Hib) vaccine 8 into the Brazilian routine immunization schedule in 2002 offers an opportunity to evaluate the performance of the PSAEFI. The DTwP/Hib vaccine was chosen as it is supplied by a single manufacturer 9 and has been associated with most AEFI reports in Brazil 10 .…”