Segurança da vacina de febre amarela em idosos: uma revisão sistemática e metanálise
Segurança da vacina de febre amarela em idosos: uma revisão sistemática e metanálise
Data
2021
Autores
Abreu, Ariane de Jesus Lopes de
Journal Title
Journal ISSN
Volume Title
Publisher
Instituto Nacional de Cardiologia
Resumo
A vacina contra a febre amarela é considerada eficaz e segura, porém é contraindicada para alguns grupos específicos devido ao risco de desenvolvimento de eventos adversos. Para indivíduos acima de 60 anos, a vacina é indicada mediante uma avaliação de risco-benefício. Estudos reportaram haver um risco aumentado de eventos adversos graves entre a população idosa (≥60 anos) após a vacinação contra febre amarela, porém as evidências existentes ainda são limitadas. O objetivo deste trabalho foi avaliar o risco de eventos adversos graves em idosos pós-vacinação contra febre amarela em comparação com a população não idosa. Foi realizada uma revisão sistemática utilizando diferentes bases de dados (Medline, Embase, Web of Science, Scopus, Lilacs, Database of Abstracts of Review of Effects e Toxiline), assim como fontes de literatura cinzenta e dados de vigilância de eventos adversos pós-vacinação. Os estudos incluídos não possuíam restrição de idioma e data de publicação. Foram incluídos estudos de ensaios clínicos, coorte, caso-controle e série de casos que tinham como intervenção a vacina contra febre amarela, independente de sua linhagem, e possuíam como desfecho eventos adversos graves (anafilaxia, manifestações neurológicas associada à vacina, doença viscerotrópica associada à vacina e óbito) em indivíduos ≥60 anos. O processo das etapas de seleção e extração da revisão foram conduzidos de forma independente por dois revisores e as discordâncias resolvidas em consenso. Os estudos incluídos na revisão foram analisados de forma descritiva, metanalizados e expressos em razão de riscos com intervalo de confiança de 95%, dependendo do grau de heterogeneidade encontrado. Uma análise de subgrupo, baseada nos dados de idade, e de sensibilidade foi realizada para examinar as contribuições individuais dos estudos na representatividade geral da heterogeneidade encontrada. Para exame de viés de publicação, foram realizados os testes de Egger e Begg e o gráfico de funil. Os dados advindos de fontes de vigilância de eventos adversos foram analisados de forma descritiva. Os programas EndNote® e R versão 4.0.2 foram utilizados para a seleção e análise dos dados. Para análise da qualidade metodológica dos estudos e das evidências foram utilizadas as ferramentas Risk-of-bias tool for randomized trials (RoB 2.0), Risk Of Bias in Non-randomized Studies - of Interventions (ROBINS-I) e o sistema GRADE. No total, dezessete estudos foram incluídos na revisão. Os resultados da metanálise mostram uma prevalência de 14 eventos adversos graves para cada 1.000.000 de vacinados e que o risco de eventos adversos graves após a vacinação contra a febre amarela é 2,51 vezes maior para idosos quando comparados à população não idosa. Dentre os tipos de eventos analisados, o risco para doença viscerotrópica associada à vacina foi até seis vezes maior quando comparado a população abaixo de 60 anos. Essa mesma tendência quanto a risco por faixa etária e tipo de evento adverso grave foi observada na análise dos dados obtidos pelo VAERS e SI-PNI. A evidência encontrada nesta revisão corrobora que a indicação da vacina contra febre amarela em indivíduos com mais de 60 anos de idade deve ser baseada em uma análise cuidadosa da avaliação de risco-benefício individual.
Palavras-chave: Vacina contra Febre Amarela, Eventos Adversos, Revisão Sistemática, Idoso
Yellow fever vaccine is considered effective and safe, but it is contraindicated for some specific groups due to the risk of developing adverse events. For individuals over 60 years of age, the vaccine is indicated based on a benefit-risk assessment. Studies show that there is an increased risk of serious adverse events among the elderly population (≥60 years) after yellow fever vaccination, but the existing evidence is still limited. The aim of this study was to assess the risk of serious adverse events in elderly people after vaccination against yellow fever compared to the non-elderly population. A systematic review was performed using different databases (Medline, Embase, Web of Science, Scopus, Lilacs, Database of Abstracts of Review of Effects and Toxiline), as well as gray literature sources and post-vaccination adverse event surveillance data. The included studies did not have language and publication date restrictions. Clinical trials, cohort, case-control and case series studies were included if they had yellow fever vaccine as the intervention, regardless of its lineage, and had serious adverse events as an outcome (anaphylaxis, neurological manifestations associated with the vaccine, vaccine-associated viscerotropic disease and death) in individuals ≥60 years of age. The process of the review selection and extraction steps were independently conducted by two reviewers and disagreements were solved in consensus. The studies included in the review were descriptively analyzed, meta-analyzed and expressed as a risk ratio with a 95% confidence interval, depending on the degree of heterogeneity found. A subgroup analysis based on age and sensitivity data was performed to examine individual studies' contributions to overall representativeness of the heterogeneity found. To examine publication bias, the Egger and Begg tests and the funnel graph were performed. Data from adverse event surveillance sources were analyzed descriptively. EndNote® and R version 4.0.2 programs were used for data selection and analysis. To analyze the methodological quality of the studies and the evidence, the Risk-of-bias tool for randomized trials (RoB 2.0), Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) and the GRADE system were used. In total seventeen studies were included in the review. The result of the meta-analysis shows that the prevalence of serious adverse events is 14 per 1,000,000 vaccinated and that the risk of serious adverse events after yellow fever vaccination is 2.51 times higher for the elderly compared to the non-elderly population. Among the types of events analyzed, the risk for vaccine-associated viscerotropic disease was up to six times higher when compared to the population under 60 years of age. This same trend in terms of risk by age group and type of serious adverse event was observed in the analysis of data obtained by VAERS and SI-PNI. The evidence found in this review supports that the indication of yellow fever vaccine in individuals over 60 years of age should be based on a careful analysis of the individual benefit-risk assessment. Keywords: Yellow Fever Vaccine, Adverse Events, Systematic Review, Aged
Yellow fever vaccine is considered effective and safe, but it is contraindicated for some specific groups due to the risk of developing adverse events. For individuals over 60 years of age, the vaccine is indicated based on a benefit-risk assessment. Studies show that there is an increased risk of serious adverse events among the elderly population (≥60 years) after yellow fever vaccination, but the existing evidence is still limited. The aim of this study was to assess the risk of serious adverse events in elderly people after vaccination against yellow fever compared to the non-elderly population. A systematic review was performed using different databases (Medline, Embase, Web of Science, Scopus, Lilacs, Database of Abstracts of Review of Effects and Toxiline), as well as gray literature sources and post-vaccination adverse event surveillance data. The included studies did not have language and publication date restrictions. Clinical trials, cohort, case-control and case series studies were included if they had yellow fever vaccine as the intervention, regardless of its lineage, and had serious adverse events as an outcome (anaphylaxis, neurological manifestations associated with the vaccine, vaccine-associated viscerotropic disease and death) in individuals ≥60 years of age. The process of the review selection and extraction steps were independently conducted by two reviewers and disagreements were solved in consensus. The studies included in the review were descriptively analyzed, meta-analyzed and expressed as a risk ratio with a 95% confidence interval, depending on the degree of heterogeneity found. A subgroup analysis based on age and sensitivity data was performed to examine individual studies' contributions to overall representativeness of the heterogeneity found. To examine publication bias, the Egger and Begg tests and the funnel graph were performed. Data from adverse event surveillance sources were analyzed descriptively. EndNote® and R version 4.0.2 programs were used for data selection and analysis. To analyze the methodological quality of the studies and the evidence, the Risk-of-bias tool for randomized trials (RoB 2.0), Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) and the GRADE system were used. In total seventeen studies were included in the review. The result of the meta-analysis shows that the prevalence of serious adverse events is 14 per 1,000,000 vaccinated and that the risk of serious adverse events after yellow fever vaccination is 2.51 times higher for the elderly compared to the non-elderly population. Among the types of events analyzed, the risk for vaccine-associated viscerotropic disease was up to six times higher when compared to the population under 60 years of age. This same trend in terms of risk by age group and type of serious adverse event was observed in the analysis of data obtained by VAERS and SI-PNI. The evidence found in this review supports that the indication of yellow fever vaccine in individuals over 60 years of age should be based on a careful analysis of the individual benefit-risk assessment. Keywords: Yellow Fever Vaccine, Adverse Events, Systematic Review, Aged
Description
Palavras-chave
Vacina contra Febre Amarela, Eventos Adversos, Revisão Sistemática, Idoso, Yellow Fever Vaccine, Adverse Events, Systematic Review, Aged
Citação
Lagos LWA. Segurança da vacina de febre amarela em idosos: uma revisão sistemática e metanálise. Rio de Janeiro. Dissertação [Mestrado Profissional em Avaliação de Tecnologias em Saúde] Instituto Nacional de Cardiologia - INC; 2021.