Incidência de anafilaxia relacionada às vacinas do Programa Nacional de Imunizações
Incidence of vaccine-related anaphylaxis from Brazil's National Immunization Program
Debora Demenech Hernandes; Jorge Kalil; Carla Dinamerica Kobayashi; Ana Karolina Barreto Berselli Marinho
Resumo
A incidência de anafilaxia pós-vacinal é um evento de saúde raro e carece de melhor detalhamento no Brasil. Neste estudo, objetivou-se descrever a incidência de anafilaxia como evento supostamente atribuído à vacinação e imunização (ESAVI) das vacinas do Programa Nacional de Imunizações (PNI). Foi realizado estudo retrospectivo com dados extraídos do sistema de notificação de ESAVI do PNI entre 01/2021 e 05/2023 com aceitação na Plataforma Brasil e aprovação ética. Foram identificados 84 casos encerrados com o descritor “anafilaxia” ou “choque anafilático” entre 290.101 eventos adversos notificados, concentrados principalmente nas regiões Sul e Sudeste. Crianças de 0 a 9 anos foram predominantemente afetadas, com maior incidência em mulheres e indivíduos brancos. A anafilaxia associou-se em números absolutos principalmente às vacinas COVID-19, destacando os fabricantes AstraZeneca/Fiocruz (vetor viral), Pfizer Comirnaty (RNAm) e CoronaVac (inativada), e a maior taxa de incidência foi com a vacina antirrábica (2,8 por milhão de doses aplicadas). A incidência global foi de 0,14/milhão de doses aplicadas. Entre os desfechos não foi relatado óbito. A subnotificação de casos é relevante e sublinha a importância de manter sistemas robustos de vigilância e manejo de reações alérgicas em programas de vacinação. Este estudo segue tendências mundiais da raridade da anafilaxia relacionada às vacinas. Os dados reforçam a segurança das vacinas COVID-19 e demais vacinas existentes no PNI, independente da demografia analisada.
Palavras-chave
Abstract
Vaccine-related anaphylaxis is a rare health event, and its incidence requires further investigation in Brazil. The objective of this study was to describe the incidence of anaphylaxis as an event supposedly attributed to vaccination and immunization (ESAVI) associated with the Brazilian National Immunization Program (PNI). A retrospective study was conducted with data extracted from the PNI ESAVI notification system between January 2021 and May 2023, with ethical approval and registration in Plataforma Brasil. Among 290,101 adverse events reported, 84 cases closed with the descriptor "anaphylaxis" or "anaphylactic shock" were identified, mainly concentrated in the South and Southeast regions. Children aged 0 to 9 years were predominantly affected, with a higher incidence in women and white individuals. In absolute numbers, anaphylaxis was associated mainly with the AstraZeneca/Fiocruz (viral vector), Pfizer Comirnaty (mRNA), and CoronaVac (inactivated virus) COVID-19 vaccines, while the highest relative incidence was with the anti-rabies vaccine (2.8 cases per million doses administered). The overall incidence was 0.14 per million vaccine doses. No deaths were reported. Underreporting of vaccine-related anaphylaxis is relevant and highlights the importance of maintaining robust systems for surveillance and management of allergic reactions within vaccination programs. This study corroborates global trends in the rarity of vaccine-related anaphylaxis. The low incidence of this event, regardless of recipient demographics, provides further evidence of the safety of COVID-19 vaccines and other vaccines included in the PNI.
Keywords
Referências
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Submetido em:
08/03/2024
Aceito em:
14/03/2024
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