Perfil dos eventos supostamente atribuíveis à vacina Covid em crianças e adolescentes da cidade de Curitiba, notificados no ano de 2022
Tipo
TCC
Data de publicação
2024-05-23
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Citações (Scopus)
Autores
Dazzi, Camila Ortolan
Baldacconi, Isabella Dória
Baldacconi, Isabella Dória
Orientador
Rossoni, Andrea Maciel de Oliveira
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Resumo
A COVID-19, infecção causada pelo novo coronavírus 2 (SARS-CoV-2), é responsável pela Síndrome Respiratória Aguda Grave (SRAG). Crianças e adolescentes estão suscetíveis à infecção pelo vírus e com risco de complicações. Após a liberação das vacinas, alterou-se o cenário crítico da pandemia, no entanto, os relatos de diversas reações adversas da vacina foram, e ainda são, motivo para muitos optarem por não imunizarem seus filhos, o que traz grande risco à saúde pública, aumentando as chances de uma nova onda da pandemia. Objetivos: Analisar todos os eventos supostamente atribuíveis à vacinação e imunização (ESAVI) da COVID, em crianças e adolescentes, assim como, verificar a frequência de eventos adversos graves na aplicação de rotina em Curitiba, no ano de 2022. Metodologia: Trata-se de um estudo descritivo, analítico, transversal com coleta de dados retrospectiva, utilizando dados secundários da Secretaria Municipal de Saúde de Curitiba. A amostra foi composta por todos os ESAVI da COVID, em indivíduos de 6 meses a 18 anos incompletos, na cidade de Curitiba, notificadas no Sistema de Notificação e-SUS Notifica, referentes ao ano de 2022. Este trabalho foi aprovado pelo CEP das instituições, sob o CAAE nº. 69161923.1.3001.0101. Resultados: Nesse período foram aplicadas 394.241 doses e do total de notificados 299 foram considerados ESAVI e 158 foram classificadas como erros de aplicação (34,5%). A incidência dos ESAVI foi de 75,8 eventos a cada 100.000 doses aplicadas. Dentre eles, os considerados não graves foram: febre (52,5%), sintomas gastrointestinais (30,8%), sintomas respiratórios (31,1%), sintomas no local da aplicação (26,4%), mialgia (22,1%), astenia, cansaço e prostração (15%), calafrios e tremor (12,4%) e sintomas alérgicos (9,4%). As demais reações consideradas não graves tiveram incidência menor do que 5%. Apenas 1,3% foi considerado grave, sendo estes: miocardite, dor torácica, plaquetopenia e parestesia de membros. A incidência de eventos graves correspondeu a 1 caso a cada 100.000 doses aplicadas. Nenhum óbito foi registrado e não houve relatos de sequelas. A média da idade foi de 9,11 anos (±0,19; IC 95% 8,72 – 9,50), sendo que por faixa etária, a de maior prevalência foi entre 5-9 anos (50,5%). Não houve diferença em relação ao sexo (50,2% ocorreram no sexo feminino). A vacina que apresentou a maior frequência com os eventos adversos foi a Pfizer® pediátrica, em (44,5%) dos casos, seguida da CoronaVac® (33,4%); 57,9% ocorreram na primeira dose; 31,4% na segunda dose e 10,7% nas demais doses. A média do intervalo entre aplicação e início dos sintomas foi de 1,35 dias (±0,9; IC 95% 1,16 – 1,54). Conclusão: Os eventos adversos à vacina ocorreram numa baixa frequência e sem gravidade. Nenhum óbito pela vacina foi registrado, em comparação com a doença, que apresentou 34,7 óbitos a cada 100 mil crianças no mesmo período. Conclui-se que os ESAVI da COVID não justificam o cenário atual de hesitação vacinal.
COVID-19, caused by the novel coronavirus 2 (SARS-CoV-2), leads to Severe Acute Respiratory Syndrome (SARS). Children and adolescents are susceptible to virus infection and at risk of complications. Despite the critical pandemic landscape changing post-vaccine release, reports of various vaccine adverse reactions have led many to refrain from vaccinating their children, posing significant public health risks and increasing the likelihood of a new pandemic wave. Objectives: To analyze all events supposedly attributable to COVID vaccination and immunization (ESAVI) in children and adolescents, as well as to assess the frequency of severe adverse events during routine administration in Curitiba in the year 2022. Methodology: This is a descriptive, analytical, cross-sectional study with retrospective data collection, utilizing secondary data from the Municipal Health Department of Curitiba. The sample comprised all COVID ESAVI cases in individuals aged 6 months to less than 18 years in the city of Curitiba, reported in the e-SUS Notification System, for the year 2022. This study was approved by the Institutional Review Boards under protocol number CAAE 69161923.1.3001.0101. Results: During this period, 394,241 doses were administered, and out of the total reported, 299 were considered COVID ESAVI, with 158 classified as application errors (34.5%). The incidence of ESAVI was 75.8 events per 100,000 doses administered. Among these, those considered non-severe were: fever (52.5%), gastrointestinal symptoms (30.8%), respiratory symptoms (31.1%), local application site symptoms (26.4%), myalgia (22.1%), asthenia, fatigue, and prostration (15%), chills and tremor (12.4%), and allergic symptoms (9.4%). Other reactions considered non-severe had an incidence of less than 5%. Only 1.3% were considered severe, including myocarditis, chest pain, thrombocytopenia, and limb paresthesia (one case each). The incidence of severe events corresponded to 1 case per 100,000 doses administered. No deaths were recorded, and there were no reports of sequelae. The mean age was 9.11 years (±0.19; 95% CI 8.72 – 9.50), with the highest prevalence by age group being between 5-9 years (50.5%). There was no difference regarding gender (50.2% occurred in females). The vaccine with the highest frequency of adverse events was the pediatric Pfizer®, in (44.5%) of cases, followed by CoronaVac® (33.4%); 57.9% occurred after the first dose, 31.4% after the second dose, and 10.7% after subsequent doses. The mean interval between administration and symptom onset was 1.35 days (±0.9; 95% CI 1.16 – 1.54). Conclusion: Adverse events following immunization (AEFI) transpired at a low frequency and severity. No vaccine-related fatalities were recorded, contrasting with the disease which exhibited 34.7 deaths per 100,000 children during the same period. It is concluded that COVID AEFIs do not substantiate the current landscape of vaccine hesitancy.
COVID-19, caused by the novel coronavirus 2 (SARS-CoV-2), leads to Severe Acute Respiratory Syndrome (SARS). Children and adolescents are susceptible to virus infection and at risk of complications. Despite the critical pandemic landscape changing post-vaccine release, reports of various vaccine adverse reactions have led many to refrain from vaccinating their children, posing significant public health risks and increasing the likelihood of a new pandemic wave. Objectives: To analyze all events supposedly attributable to COVID vaccination and immunization (ESAVI) in children and adolescents, as well as to assess the frequency of severe adverse events during routine administration in Curitiba in the year 2022. Methodology: This is a descriptive, analytical, cross-sectional study with retrospective data collection, utilizing secondary data from the Municipal Health Department of Curitiba. The sample comprised all COVID ESAVI cases in individuals aged 6 months to less than 18 years in the city of Curitiba, reported in the e-SUS Notification System, for the year 2022. This study was approved by the Institutional Review Boards under protocol number CAAE 69161923.1.3001.0101. Results: During this period, 394,241 doses were administered, and out of the total reported, 299 were considered COVID ESAVI, with 158 classified as application errors (34.5%). The incidence of ESAVI was 75.8 events per 100,000 doses administered. Among these, those considered non-severe were: fever (52.5%), gastrointestinal symptoms (30.8%), respiratory symptoms (31.1%), local application site symptoms (26.4%), myalgia (22.1%), asthenia, fatigue, and prostration (15%), chills and tremor (12.4%), and allergic symptoms (9.4%). Other reactions considered non-severe had an incidence of less than 5%. Only 1.3% were considered severe, including myocarditis, chest pain, thrombocytopenia, and limb paresthesia (one case each). The incidence of severe events corresponded to 1 case per 100,000 doses administered. No deaths were recorded, and there were no reports of sequelae. The mean age was 9.11 years (±0.19; 95% CI 8.72 – 9.50), with the highest prevalence by age group being between 5-9 years (50.5%). There was no difference regarding gender (50.2% occurred in females). The vaccine with the highest frequency of adverse events was the pediatric Pfizer®, in (44.5%) of cases, followed by CoronaVac® (33.4%); 57.9% occurred after the first dose, 31.4% after the second dose, and 10.7% after subsequent doses. The mean interval between administration and symptom onset was 1.35 days (±0.9; 95% CI 1.16 – 1.54). Conclusion: Adverse events following immunization (AEFI) transpired at a low frequency and severity. No vaccine-related fatalities were recorded, contrasting with the disease which exhibited 34.7 deaths per 100,000 children during the same period. It is concluded that COVID AEFIs do not substantiate the current landscape of vaccine hesitancy.
Descrição
Palavras-chave
imunização , SARS-CoV-2 , reações adversas , immunization , SARS-CoV-2 , adverse reactions