RESUMEN
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.
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.
Asunto(s)
HumanosAsunto(s)
Humanos , Femenino , Embarazo , Aborto Espontáneo , Vacunas contra la COVID-19 , COVID-19/prevención & controlRESUMEN
Regulations for the vaccination of pregnant women in Brazil occurred in March 2021. Despite the absence of robust data in the literature on the coronavirus disease 2019 (COVID-19) vaccinations in pregnant women, it is understood that the benefit-risk ratio tends to be favorable when considering the pandemic and the high burden of the disease. However, it is still important to monitor for Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to draw safety profiles of the different platforms used in pregnant and postpartum women. The present study aims to describe the main characteristics of ESAVIs related to COVID-19 vaccines occurring in pregnant women in the first months of the vaccination campaign in Brazil. During the evaluation period, 1,674 notifications of ESAVIs in pregnant women were recorded, and 582 notifications were included for the analysis. Of the 582 ESAVIs identified, 481 (82%) were classified as non-serious adverse events and 101 (17%) as serious adverse events. Ten deaths were identified, including one death which was considered to be causally related to the vaccine. The other nine maternal deaths had causality C, that is, without causal relationship with the vaccine, and most were due to complications inherent to pregnancy, such as pregnancy-specific hypertensive disorder (PSHD) in 4 cases and 3 due to COVID-19. Despite some limitations in our study, we believe it brings new insights into COVID-19 vaccines in this group and will add to the available evidence.
As determinações vacinação nas gestantes foram estabelecidas em março de 2021, no Brasil. Apesar da ausência de dados robustos na literatura da vacinação contra coronavirus disease 2019 (COVID-19) nesse grupo, entende-se que a relação de benefício versus risco tende a ser favorável considerando a situação pandêmica e a elevada carga de doença, tendo justificado o uso dessas vacinas em ampla escala nas gestantes de todo o mundo. Entretanto, o monitoramento dos eventos adversos pós vacinação (EAPVs) torna-se ainda mais importante para traçar um perfil de segurança das diferentes plataformas nas gestantes e puérperas. O presente estudo tem como objetivo descrever as principais características dos EAPVs contra COVID-19 ocorridos nas gestantes nos primeiros meses de campanha da vacinação no Brasil. Foram identificadas 1.674 notificações em gestantes, com a inclusão de 582 EAPVs analisados. Dos 582 EAPVs identificados, 481 (82%) foram classificados como eventos adversos não-graves e 101 (17%) como eventos adversos graves, sendo 10 (9,9%) destes referentes aos óbitos. Apenas um caso de óbito materno teve relação causal com a vacinação comprovada (causalidade A1), e foi secundário à síndrome trombocitopênica trombótica (TTS) após a vacina AstraZeneca/Fiocruz. Os outros nove óbitos maternos tiveram causalidade C, ou seja, sem relação causal com a vacina, e a maioria por complicações inerentes à gravidez, como a doença hipertensiva específica da gestação (DHEG) e COVID-19. Apesar de algumas limitações em nosso estudo, acreditamos que ele traz dados importantes sobre as vacinas COVID-19 neste grupo aumentando as evidências disponíveis.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Brasil/epidemiología , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Femenino , Humanos , Embarazo , Mujeres Embarazadas , Vacunación , Vacunas/efectos adversosRESUMEN
Abstract Regulations for the vaccination of pregnant women in Brazil occurred in March 2021. Despite the absence of robust data in the literature on the coronavirus disease 2019 (COVID-19) vaccinations in pregnant women, it is understood that the benefit-risk ratio tends to be favorable when considering the pandemic and the high burden of the disease. However, it is still important to monitor for Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to draw safety profiles of the different platforms used in pregnant and postpartum women. The present study aims to describe the main characteristics of ESAVIs related to COVID-19 vaccines occurring in pregnant women in the first months of the vaccination campaign in Brazil. During the evaluation period, 1,674 notifications of ESAVIs in pregnant women were recorded, and 582 notifications were included for the analysis. Of the 582 ESAVIs identified, 481 (82%) were classified as non-serious adverse events and 101 (17%) as serious adverse events. Ten deaths were identified, including one death which was considered to be causally related to the vaccine. The other nine maternal deaths had causality C, that is, without causal relationship with the vaccine, and most were due to complications inherent to pregnancy, such as pregnancy-specific hypertensive disorder (PSHD) in 4 cases and 3 due to COVID-19. Despite some limitations in our study, we believe it brings new insights into COVID-19 vaccines in this group and will add to the available evidence.
Resumo As determinações vacinação nas gestantes foram estabelecidas em março de 2021, no Brasil. Apesar da ausência de dados robustos na literatura da vacinação contra coronavirus disease 2019 (COVID-19) nesse grupo, entende-se que a relação de benefício versus risco tende a ser favorável considerando a situação pandêmica e a elevada carga de doença, tendo justificado o uso dessas vacinas em ampla escala nas gestantes de todo o mundo. Entretanto, o monitoramento dos eventos adversos pós vacinação (EAPVs) torna-se ainda mais importante para traçar um perfil de segurança das diferentes plataformas nas gestantes e puérperas. O presente estudo tem como objetivo descrever as principais características dos EAPVs contra COVID-19 ocorridos nas gestantes nos primeiros meses de campanha da vacinação no Brasil. Foram identificadas 1.674 notificações em gestantes, com a inclusão de 582 EAPVs analisados. Dos 582 EAPVs identificados, 481 (82%) foram classificados como eventos adversos não-graves e 101 (17%) como eventos adversos graves, sendo 10 (9,9%) destes referentes aos óbitos. Apenas um caso de óbito materno teve relação causal com a vacinação comprovada (causalidade A1), e foi secundário à síndrome trombocitopênica trombótica (TTS) após a vacina AstraZeneca/Fiocruz. Os outros nove óbitos maternos tiveram causalidade C, ou seja, sem relação causal com a vacina, e a maioria por complicações inerentes à gravidez, como a doença hipertensiva específica da gestação (DHEG) e COVID-19. Apesar de algumas limitações em nosso estudo, acreditamos que ele traz dados importantes sobre as vacinas COVID-19 neste grupo aumentando as evidências disponíveis.
Asunto(s)
Humanos , Femenino , Embarazo , Brasil , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Enfermedades Prevenibles por Vacunación , Vacunas contra la COVID-19/efectos adversosRESUMEN
Determination of the neutrophil gelatinase-associated lipocalin (NGAL) level can be used to detect acute kidney injury (AKI) earlier than determination of the serum creatinine (SCr) level in settings such as cardiac surgery, contrast nephropathy, and intensive care units. We hypothesized that urine NGAL (UrNGAL) would be an early biomarker of drug nephrotoxicity. To test this, we studied hemodynamically stable patients treated with amphotericin B (AmB). We measured the SCr and UrNGAL levels at the baseline and daily after initiation of AmB up to day 14 or development of AKI by the use of the SCr criterion. AKI was defined according to a Kidney Disease: Improving Global Outcomes (KDIGO) criterion (an increase in the SCr level by ≥0.3 mg/dl within 48 h or an SCr level ≥1.5 times the baseline level within 7 days). We studied 24 patients with a mean age of 48.4 ± 16.4 years. Most patients were male, and the patients received AmB (12 received AmB deoxycholate and 12 received liposomal AmB) for the treatment of leishmaniasis (91.7%). Overall, 17/24 patients fulfilled a KDIGO criterion for AKI. Peak UrNGAL levels were higher in patients with AKI than in patients without AKI and in recipients of AmB deoxycholate than in recipients of liposomal AmB. The diagnostic performance of the UrNGAL level on day 5 for the detection of AKI was moderate, with the area under the curve (AUC) being 0.68 (95% confidence interval [CI], 0.41 to 0.95). In the subgroup receiving AmB deoxycholate, however, the AUC rose to 0.89 (95% CI, 0.67 to 1.00). In a patient-level analysis, we found that AKI could be detected 3.2 days earlier by the use of the UrNGAL criterion than by the use of the SCr criterion (times to AKI by the UrNGAL and SCr criteria, 3.7 ± 2.5 versus 6.9 ± 3.3 days, respectively; P = 0.001). Future studies should evaluate if a treatment strategy oriented toward evaluation of UrNGAL levels will improve outcomes. These findings for AmB-induced AKI in leishmaniasis patients could serve as a basis for the investigation of urine biomarkers in the early detection of drug nephrotoxicity in other clinical settings.
Asunto(s)
Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/diagnóstico , Anfotericina B/efectos adversos , Lipocalinas/sangre , Lesión Renal Aguda/sangre , Adulto , Anfotericina B/uso terapéutico , Creatinina/sangre , Ácido Desoxicólico/efectos adversos , Ácido Desoxicólico/uso terapéutico , Combinación de Medicamentos , Femenino , Hemodinámica , Humanos , Leishmaniasis/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Studies on amphotericin B (AmB) nephrotoxicity use diverse definitions of acute kidney injury (AKI). Here, we used the new Kidney Disease Improving Global Outcome (KDIGO) system to describe the incidence, predictors, and impact of AmB-induced AKI on hospital mortality in 162 patients treated with AmB (120 with deoxycholate preparation and 42 with liposomal preparation). KDIGO stage 1 requires an absolute increase of ≥0.3 mg/dl or ≥1.5× over baseline serum creatinine (SCr), while stage 2 requires ≥2×, and stage 3 requires ≥3×. A binary KDIGO definition (KDIGObin) corresponds to stage ≥1. For comparison, we included two definitions of AKI traditionally utilized in nephrotoxicity studies: ≥0.5 mg/dl (NT0.5) and ≥2× (NT2×) increase in baseline SCr. The overall incidence of AmB-induced AKI by KDIGObin was 58.6% (stage 1, 30.9%; stage 2, 18.5%; stage 3, 9.3%). Predictors of AKI by KDIGObin were older age and use of furosemide and angiotensin-converting enzyme inhibitor (ACE-I). Traditional criteria detected lower incidences of AKI, at 45.1% (NT0.5) and 27.8% (NT2×). Predictors of AKI by traditional criteria were older age and use of vancomycin (NT0.5) and use of vancomycin and vasopressors (NT2×). KDIGObin detected AKI 2 days earlier than the most sensitive traditional criterion. However, only traditional criteria were associated with intensive care unit (ICU) admission, mechanical ventilation, and mortality. In conclusion, the increase in sensitivity of KDIGObin is accompanied by a loss of specificity and ability to predict outcomes. Prospective studies are required to weigh the potential gain from early AKI detection against the potential loss from undue changes in management in patients with subtle elevations in SCr.