Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-EAPV): vantagens e desafios / Post-Vaccination Adverse Event Information System (SI-EAPV): advantages and challenges

Moura, Ana Débora Assis; Rouberte, Emília Soares Chaves; Lima, Francisca Elisângela Teixeira; Chaves, Cristianne Soares; Canto, Surama Valena Elarrat; Lima, Guldemar Gomes de

doi:10.34119/bjhrv3n5-334

Cited by 2 publications

(1 citation statement)

References 3 publications

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“…The NIP is responsible for the registration, investigation and causality analysis of AEFI reported by the public health system. 12 For this study we requested the SI-EAPV (AEFI Surveillance Information System) dataset to the Brazilian MoH, using the Fala BR platform (https://www.gov.br/acessoainformacao/pt-br/falabr). 13 This system is linked to the national system for reporting AE related to the use of drugs and vaccines in VigiMed, adopted at the end of 2018 by Anvisa, as a result of its partnership with the Uppsala Monitoring Centre (UMC).…”

Section: Methodsmentioning

confidence: 99%

Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil

Qiao

Abreu²,

Dias³

et al. 2021

Preprint

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BackgroundAlthough COVID-19 vaccines are currently under use in pregnant and postpartum women, there is still lack of evidence regarding safety and effectiveness in these populations. This study aims to describe the safety profile of COVID-19 vaccines in pregnant and postpartum women in the early stage of vaccination campaign in Brazil.MethodsThis is an observational cross-sectional study using data from the Brazilian surveillance information system for adverse events (SI-EAPV) to characterize the safety of COVID-19 vaccines available (Sinovac/Butantan, Pfizer/BioNTech, AstraZeneca and Janssen) in Brazilian pregnant and postpartum women after receiving it from April to August 2021. A descriptive analysis was performed to assess the frequency and incidence rate of the adverse events (AE) for COVID-19 vaccines.ResultsA total of 3,333 adverse events following COVID-19 immunization were reported for the study population in the SIEAPV. The incidence of AE found was 309.4/100,000 doses (95% CI 297.23, 321.51). Regarding the four vaccines available in the country, Sinovac/Butantan had the lowest incidence (74.08/100,000 doses; 95% CI 63.47, 84.69). Systemic events were the most frequent notified for the group (82.07%), followed by local (11.93%) and maternal (4.74%), being most of them classified as non-severe (90.65%).ConclusionA similar pattern of AE as stated in other studies was found, with even better results for non-viral vector vaccines, corroborating to the recommendation of vaccination for these groups. Even though, further studies appraising a longer observation time are still needed to provide a broader safety aspect for the vaccines currently under use for this population.

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Section: Methodsmentioning

confidence: 99%

Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil

Qiao

Abreu²,

Dias³

et al. 2021

Preprint

View full text Add to dashboard Cite

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Adverse events of COVID-19 vaccines in pregnant and postpartum women in Brazil: A cross-sectional study

Covas

Abreu²,

Dias³

et al. 2023

PLoS ONE

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Background By the fact that pregnant and postpartum women are currently using COVID-19 vaccines, ensure their safety is critical. So, more safety evidence is crucial to include this new technology to their vaccine’s calendar and to develop public policies regarding the support and training of Health Care Personnel. This study aims to describe the adverse events (AE) of COVID-19 vaccines in pregnant and postpartum women in the early stage of vaccination campaign in Brazil. Methods An observational cross-sectional study using data from the Brazilian surveillance information system to characterize the AE of COVID-19 vaccines (Sinovac/Butantan, Pfizer/BioNTech, AstraZeneca and Janssen) in Brazilian pregnant and postpartum women from April to August 2021. Frequency and incidence rate of AE for COVID-19 vaccines were assessed. Results 3,333 AE following immunization were reported for the study population. AE incidence was 309.4/100,000 doses (95% CI 297.23, 321.51). Within the vaccines available, Sinovac/Butantan had the lowest incidence (74.08/100,000 doses; 95% CI 63.47, 84.69). Systemic events were the most frequent notified (82.07%), followed by local (11.93%) and maternal (4.74%), being most of them classified as non-severe (90.65%). Conclusion Our results corroborate the recommendation of vaccination for these groups. Even though, further studies appraising a longer observation time are still needed to provide a broader safety aspect for the vaccines currently under use for this population.

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Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-EAPV): vantagens e desafios / Post-Vaccination Adverse Event Information System (SI-EAPV): advantages and challenges

Cited by 2 publications

References 3 publications

Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil

Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil

Adverse events of COVID-19 vaccines in pregnant and postpartum women in Brazil: A cross-sectional study

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