Immunogenicity and safety of inactivated SARS-CoV-2 vaccine (CoronaVac) using two-dose primary protocol in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up.

Introduction: Vaccines are essential for the prevention and control of several diseases, indeed, monitoring the immune response generated by vaccines is crucial. The immune response generated by vaccination against SARS-CoV-2 in children and adolescents is not well defined regarding to the intensity and medium to long-term duration of a protective immune response, which may point out the need of booster doses and might support the decisions in public health. Objective: The study aims to evaluate the immunogenicity and safety of inactivated SARS-CoV-2 vaccine (CoronaVac) in a two-dose primary protocol in children and adolescent aging from 3 to 17 years old in Brazil. Methods: Participants were invited to participate in the research at two public healthcare centers located in Serrana (São Paulo) and Belo Horizonte (Minas Gerais), Brazil. Participants underwent medical interviews to gather their medical history, including COVID-19 history and medical records. Physical exams were conducted, including weight, blood pressure, temperature, and pulse rate measurements. Blood samples were obtained from the participants before vaccination, 1 month after the first dose, and 1, 3, and 6 months after the second dose and were followed by a virtual platform for monitoring post-vaccination reactions and symptoms of COVID-19. SARS-CoV-2 genome from Swab samples of COVID-19 positive individuals were sequenced by NGS. Total antibodies were measured by ELISA and neutralizing antibodies to B.1 lineage and Omicron variant (BA.1) quantified by PRNT and VNT. The cellular immune response was evaluated by flow cytometry by the quantification of systemic soluble immune mediators. Results: The follow-up of 640 participants showed that the CoronaVac vaccine (Sinovac/Butantan Institute) was able to significantly induce the production of total IgG antibodies to SARS-CoV-2 and the production of neutralizing antibodies to B.1 lineage and Omicron variant. In addition, a robust cellular immune response was observed with wide release of pro-inflammatory and regulatory mediators in the early post-immunization moments. Adverse events recorded so far have been mild and transient except for seven serious adverse events reported on VigiMed. Conclusions: The results indicate a robust and sustained immune response induced by the CoronaVac vaccine in children and adolescents up to six months, providing evidences to support the safety and immunogenicity of this effective immunizer.

Increased Home Death Due to Cardiopulmonary Arrest in Times of COVID-19 Pandemic. / Aumento de Óbitos Domiciliares devido a Parada Cardiorrespiratória em Tempos de Pandemia de COVID-19.

BACKGROUND: Cardiovascular diseases constitute an important group of causes of death in the country. Ischemic heart diseases that are the main causes of cardiopulmonary arrest, leading to an impact on the mortality of the cardiovascular diseases in the health system. OBJECTIVE: Assess the number of home deaths by cardiopulmonary arrest notified by the Mobile Emergency Medical Service (SAMU) in March 2018, 2019 and 2020. METHODS: Observational study carried out from the analysis of cardiopulmonary arrest mortality data of citizens assisted by SAMU in Belo Horizonte, Minas Gerais, Brazil. Social and clinical characteristics and occurrence information of the patients were analyzed. The mortality rate due to cardiopulmonary arrest in relation to the total number of attendances was assessed. A significance level of 95% was considered. RESULTS: There was increase of home deaths due to cardiopulmonary arrest in March 2020 compared to March 2018 (p<0.001) and March 2019 (p=0.050). Of the deaths reported in 2020, 63.8% of the patients were aged 60 years or older, 63.7% of the occurrences were performed in the afternoon and approximately 87% of the cardiopulmonary arrest notified had associated clinical comorbidities, with systemic arterial hypertension and heart failure represented by 22.87% and 13.03% of the reported cases, respectively. The majority of the evaluated sample of this study did not have any medical care follow-up (88.7%). CONCLUSION: Considering the increase in the number of the deaths, we suggest reflections and readjustments regarding the monitoring of chronic non-transmissible diseases during a pandemic, as well as improvements in death surveillance. (Arq Bras Cardiol. 2021; 116(2):266-271).

FUNDAMENTO: As doenças cardiovasculares constituem um grupo importante de causas de morte no Brasil. As doenças isquêmicas do coração são as principais causas de parada cardiorrespiratória, levando a um impacto na mortalidade devido às doenças cardiovasculares no sistema de saúde. OBJETIVO: Avaliar o número de óbitos domiciliares por parada cardiorrespiratória notificados pelo Serviço de Atendimento Móvel de Urgência (SAMU) em março de 2018, 2019 e 2020. MÉTODOS: Trata-se de um estudo observacional realizado a partir da análise de dados de mortalidade por parada cardiorrespiratória de cidadãos atendidos pelo SAMU em Belo Horizonte, Minas Gerais, Brasil. Foram analisadas as características sociais e clínicas e as informações de ocorrência. Foi avaliada a taxa de mortalidade por parada cardiorrespiratória em relação ao número total de atendimentos. Foi considerado um nível de significância de 95%. RESULTADOS: Houve um aumento nos óbitos domiciliares por parada cardiorrespiratória em março de 2020, em comparação com março de 2018 (p < 0,001) e março de 2019 (p = 0,050). Dos óbitos relatados em 2020, 63,8% dos pacientes tinham 60 anos ou mais; 63,7% das ocorrências foram à tarde e aproximadamente 87% dos casos de parada cardiorrespiratória notificados apresentavam comorbidades clínicas, com hipertensão arterial sistêmicas e parada cardíaca correspondendo a 22,87% e 13,03% dos casos relatados, respectivamente. A maioria da amostra avaliada deste estudo não teve acompanhamento médico (88,7%). CONCLUSÃO: Considerando o aumento do número de óbitos, sugerimos reflexões e reajustes quanto ao monitoramento das doenças crônicas não transmissíveis durante a pandemia, bem como melhorias na vigilância dos óbitos. (Arq Bras Cardiol. 2021; 116(2):266-271).

Aumento de Óbitos Domiciliares devido a Parada Cardiorrespiratória em Tempos de Pandemia de COVID-19 / Increased Home Death Due to Cardiopulmonary Arrest in Times of COVID-19 Pandemic

Resumo Fundamento As doenças cardiovasculares constituem um grupo importante de causas de morte no Brasil. As doenças isquêmicas do coração são as principais causas de parada cardiorrespiratória, levando a um impacto na mortalidade devido às doenças cardiovasculares no sistema de saúde. Objetivo Avaliar o número de óbitos domiciliares por parada cardiorrespiratória notificados pelo Serviço de Atendimento Móvel de Urgência (SAMU) em março de 2018, 2019 e 2020. Métodos Trata-se de um estudo observacional realizado a partir da análise de dados de mortalidade por parada cardiorrespiratória de cidadãos atendidos pelo SAMU em Belo Horizonte, Minas Gerais, Brasil. Foram analisadas as características sociais e clínicas e as informações de ocorrência. Foi avaliada a taxa de mortalidade por parada cardiorrespiratória em relação ao número total de atendimentos. Foi considerado um nível de significância de 95%. Resultados Houve um aumento nos óbitos domiciliares por parada cardiorrespiratória em março de 2020, em comparação com março de 2018 (p < 0,001) e março de 2019 (p = 0,050). Dos óbitos relatados em 2020, 63,8% dos pacientes tinham 60 anos ou mais; 63,7% das ocorrências foram à tarde e aproximadamente 87% dos casos de parada cardiorrespiratória notificados apresentavam comorbidades clínicas, com hipertensão arterial sistêmicas e parada cardíaca correspondendo a 22,87% e 13,03% dos casos relatados, respectivamente. A maioria da amostra avaliada deste estudo não teve acompanhamento médico (88,7%). Conclusão Considerando o aumento do número de óbitos, sugerimos reflexões e reajustes quanto ao monitoramento das doenças crônicas não transmissíveis durante a pandemia, bem como melhorias na vigilância dos óbitos. (Arq Bras Cardiol. 2021; 116(2):266-271)

Abstract Background Cardiovascular diseases constitute an important group of causes of death in the country. Ischemic heart diseases that are the main causes of cardiopulmonary arrest, leading to an impact on the mortality of the cardiovascular diseases in the health system. Objective Assess the number of home deaths by cardiopulmonary arrest notified by the Mobile Emergency Medical Service (SAMU) in March 2018, 2019 and 2020. Methods Observational study carried out from the analysis of cardiopulmonary arrest mortality data of citizens assisted by SAMU in Belo Horizonte, Minas Gerais, Brazil. Social and clinical characteristics and occurrence information of the patients were analyzed. The mortality rate due to cardiopulmonary arrest in relation to the total number of attendances was assessed. A significance level of 95% was considered. Results There was increase of home deaths due to cardiopulmonary arrest in March 2020 compared to March 2018 (p<0.001) and March 2019 (p=0.050). Of the deaths reported in 2020, 63.8% of the patients were aged 60 years or older, 63.7% of the occurrences were performed in the afternoon and approximately 87% of the cardiopulmonary arrest notified had associated clinical comorbidities, with systemic arterial hypertension and heart failure represented by 22.87% and 13.03% of the reported cases, respectively. The majority of the evaluated sample of this study did not have any medical care follow-up (88.7%). Conclusion Considering the increase in the number of the deaths, we suggest reflections and readjustments regarding the monitoring of chronic non-transmissible diseases during a pandemic, as well as improvements in death surveillance. (Arq Bras Cardiol. 2021; 116(2):266-271)