Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Acute acalculous cholecystitis in systemic lupus erythematosus: a rare initial manifestation

ABSTRACT Acute acalculous cholecystitis is a very rare gastrointestinal manifestation in systemic lupus erythematosus and becomes rarer as an initial manifestation. There are only two cases reported. The authors report a 20-year-old black woman that presented acute acalculous cholecystitis revealed by abdominal computed tomography. During hospitalization, she was diagnosed systemic lupus erythematosus. Conservative treatment with antibiotics was performed with complete remission of the symptoms. Corticosteroid was started in ambulatory. Cholecystectomy has been the treatment of choice in acute acalculous cholecystitis as a complication of systemic lupus erythematosus. The patient responded well to conservative treatment, and surgery was not required. This case is unique in the way that corticosteroid was started in ambulatory care. We should not forget that the acute acalculous cholecystitis can be the initial presentation of systemic lupus erythematosus although its occurrence is very rare. Conservative treatment should be considered. Abdominal computed tomography was a determinant exam for better assessment of acute acalculous cholecystitis

Colecistite aguda acalculosa no lúpus eritematoso sistêmico: uma manifestação inicial rara

ResumoA colecistite aguda acalculosa é uma manifestação gastrointestinal rara no lúpus eritematoso sistêmico e ainda mais rara como manifestação inicial. Foram descritos apenas dois casos até o momento. Os autores relatam o caso de uma mulher negra de 20 anos, com quadro de colecistite aguda acalculosa revelada pela tomografia computadorizada do abdome. Durante a hospitalização, a paciente foi diagnosticada com lúpus eritematoso sistêmico. Houve remissão completa dos sintomas após tratamento conservador com antibióticos. Iniciou‐se tratamento com corticosteroides no ambulatório. Embora a colecistectomia seja o tratamento de escolha em casos de colecistite aguda acalculosa como complicação do lúpus eritematoso sistêmico, a paciente respondeu bem ao tratamento conservador; logo, a cirurgia não foi necessária. Este caso é único em razão do modo como o corticosteroide foi iniciado no atendimento ambulatorial. É importante lembrar que a colecistite aguda acalculosa pode ser a manifestação inicial do lúpus eritematoso sistêmico, embora sua ocorrência seja rara. Deve‐se considerar a realização de tratamento conservador. A tomografia computadorizada do abdome foi determinante para que fosse feita uma melhor avaliação da colecistite aguda acalculosa.AbstractAcute acalculous cholecystitis is a very rare gastrointestinal manifestation in systemic lupus erythematosus and becomes rarer as an initial manifestation. There are only two cases reported. The authors report a 20‐year‐old black woman that presented acute acalculous cholecystitis revealed by abdominal computed tomography. During hospitalization, she was diagnosed systemic lupus erythematosus. Conservative treatment with antibiotics was performed with complete remission of the symptoms. Corticosteroid was started in ambulatory. Cholecystectomy has been the treatment of choice in acute acalculous cholecystitis as a complication of systemic lupus erythematosus. The patient responded well to conservative treatment, and surgery was not required. This case is unique in the way that corticosteroid was started in ambulatory care. We should not forget that the acute acalculous cholecystitis can be the initial presentation of systemic lupus erythematosus although its occurrence is very rare. Conservative treatment should be considered. Abdominal computed tomography was a determinant exam for better assessment of acute acalculous cholecystitis

Hemorrhagic adrenal cyst

The authors present a case of a hemorrhagic adrenal cyst, one of the tumors known in literature as incidentalomas, emphasizing the clinical characteristics, since adrenal cysts or pseudocysts are generally rare and observed by chance during imaging procedures. Traditionally they are classified as pseudocysts, endothelial, epithelial or parasitic cysts. Laparoscopic adrenalectomy has been considered the treatment of choice for benign, functioning or non-functioning adrenal lesions. Small cystic adrenal tumors can be managed conservatively by laparoscopic decortication or marsupialization, but larger cysts should be treated by total or partial adrenalectomy

Panniculitis in the newborn: a case report

The authors present a case of panniculitis in a newborn, a rare disease in the neonatal period discussing its causes and differential diagnosis, emphasizing a possible diagnosis of erythema nodosum

Severe osteogenesis imperfecta: case report

ABSTRACT The authors present a case of Osteogenesis Imperfecta, emphasizing the clinical and epidemiological characteristics, forms of classification and treatment of the disease. This is an important case not only to the knowledge of pediatricians and orthopedists, but also for other professionals involved with the problem. This article has been jointly described by the Departments of Pediatrics and Neonatology of the Girassol Clinic in Luanda Capital of the Republic of Angola, Africa

Analisando as pesquisas em educação especial no Brasil Analysing research in special education in Brazil

Nosso objetivo foi examinar a articulação lógica entre o problema e a proposição teórico-metodológica das produções na área da Educação Especial, focando os seus pressupostos epistemológicos. Nos fundamentamos nos pressupostos das tendências empírico-analítica, fenomenológica-hermenêutica, crítico-dialética e do paradigma da complexidade. O procedimento adotado foi interpretar todas as dissertações/teses produzidas nos Programas de Pós-Graduação em Educação e Educação Especial do Brasil, que versam sobre Educação Especial, produzidas nos anos de 2001, 2002 e 2003, disponíveis no banco de teses da CAPES. Encontramos as tendências empírica, fenomenológica e dialética. Os equívocos encontrados foram a não inserção da pesquisa entre as produções na área; ausência de criticidade; não posicionamento numa determinada concepção de educação; construção teórica fundamentada em concepções diferentes; falta de coerência nos pressupostos teórico-metodológicos; não explicitação metodológica; não descrição dos procedimentos éticos; e má elaboração dos resumos. Concluímos pela necessidade da melhoria das dissertações/teses para que possamos avançar na produção de conhecimento na área da Educação Especial.<br>Our objective was to analyze the logical articulation between the problem and the theoretical-methodological proposal of studies in the field of Special Education, focusing on the epistemological issues. We based our study on the empiric-analytical tendencies, phenomenology-hermeneutic, critical-dialectical and the complexity paradigm. The procedure that was adopted was interpreting all dissertations/thesis produced in Post-Graduate programs in Education and Special Education in Brazil, which focus on Special Education, produced in 2001, 2002 and 2003, available online at CAPES' thesis database. We found empirical, phenomenological and dialectic tendencies. The errors encountered included the failure to include the research among the productions in the field; lack of critical approach; lack of making explicit what educational conception the study was based on; theoretical construction based on different conceptions; lack of coherence in the theoretical-methodological proposals; lack of methodological specification; absence of ethical procedural descriptions; and poorly written abstracts. We came to the conclusion that improvements in theses /dissertations are necessary so as to continually move forward in the production of knowledge in the field of Special Education