Brazilian recommendations on the safety and effectiveness of the yellow fever vaccination in patients with chronic immune-mediated inflammatory diseases

Background: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Main body of the abstract: Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. Conclusion: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV

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

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

Prevalência De Sorotipos De Streptococcus Grupo B Que Colonizam Gestantes De Risco Numa Maternidade Na Cidade De São Paulo

Objectives: Vaccines In Development Against Group B Streptococcus (Gbs) Should Contain The Most Prevalent Serotypes In The Population. The Key Objective Of The Study Was To Investigate The Prevalence Of Different Serotypes Of Gbs That Colonize Pregnant Women At Risk In A Private Maternity Hospital In The City Of São Paulo. The Secondary Objectives Were To Correlate The Gbs Serotypes With Maternal Age, Parity, And Risk Factors Such As Maternal Fever, Prematurity, Prolonged Membrane Rupture (18 Or More Hours Before Delivery), Intra-Amniotic Infection And Previous History Of Gbs Infection. Methods: The Study Was Developed In A Complex Of Private Maternity Hospitals Of The City Of São Paulo, Hospital E Maternidade Santa Joana And Promatre Paulista, And In The Special Laboratory Of Clinical Microbiology (Laboratório Especial De Microbiologia Clínica - Lemc) Of The Universidade Federal De São Paulo. The Strains Of Gbs Isolated In Routine Maternity Procedures, In Pregnancy At Risk, (2014-2018) Were Sent To Lemc ForObjetivos: As Vacinas Contra Streptococcus Grupo B (Egb) Em Desenvolvimento Devem Conter Os Sorotipos Mais Prevalentes Na População. O Objetivo Principal Do Estudo Foi Conhecer A Prevalência Dos Diferentes Sorotipos De Egb Que Colonizam Gestantes De Risco Numa Maternidade Privada Na Cidade De São Paulo. O Objetivo Secundário Foi Correlacionar Os Sorotipos De Egb Com Idade Materna, Paridade E Fatores De Risco Como Febre Materna, Prematuridade, Bolsa Rota Por Mais De 18 Horas, Fisometria E História Anterior De Infecção Pelo Egb. Métodos: O Estudo Foi Desenvolvido No Complexo De Maternidades Privadas Da Cidade De São Paulo, Hospital E Maternidade Santa Joana E Promatre Paulista E No Laboratório Especial De Microbiologia Clínica (Lemc) Da Universidade Federal De São Paulo. As Cepas De Egb Isoladas Nas Coletas De Rotina, De Gestantes De Risco, Nas Maternidades (2014-2018) Foram Encaminhadas Ao Lemc Para Confirmação Por Espectrometria De Massa (Maldi-Tof) Com Posterior Extração De Dna E Identificação Dos SorotiposDados abertos - Sucupira - Teses e dissertações (2018

Capsular genotype distribution of Group B Streptococcus colonization among at-risk pregnant women in Sao Paulo, Brazil.

Background: Vaccines in development against Group B Streptococcus (GBS) should contain the most prevalent capsular genotypes screened in the target population. In low- and middle-income countries epidemiological data on GBS carriage among pregnant women, a prerequisite condition for GBS neonatal sepsis, is needed to inform vaccine strategies. Objective: To investigate the prevalence of different GBS capsular genotypes that colonizes at-risk pregnant women in a private maternity hospital in São Paulo, Brazil. Methods: GBS strains isolated in routine maternity procedures from at-risk pregnant women from 2014 to 2018 were confirmed by mass spectrometry (MALDI-TOF) with subsequent DNA extraction for identification of capsular genotype through polymerase chain reaction (PCR). Demographic and gestational data were analyzed. Results: A total of 820 Todd-Hewitt broths positive for GBS were selected for streptococcal growth. Recovery and confirmation of GBS by MALDI-TOF were possible in 352. Strains were processed for determination of capsular genotype by PCR. From the total of 352 GBS isolates, 125 strains (35.5%) were genotyped as Ia; 23 (6.5%) as Ib; 41 (11.6%) as II; 36 (10.2%) as III; 4 (1.1%) as IV; 120 (34.1%) as V and 1 strain (0.3%) as VIII. Two isolates (0.7%) were not genotyped by used methodology. No statistically significant correlation between gestational risk factors, demographic data and distribution of capsular genotypes were found. Conclusions: GBS capsular genotypes Ia, Ib, II, III, and V were the most prevalent isolates colonizing at risk pregnant women in the present study. The inclusion of capsular genotypes Ia and V in the composition of future vaccines would cover 69.6% of capsular genotypes in the studied population. No statistically significant differences were observed between capsular genotype and gestational and demographic data and risk factors

Pertussis in Latin America and the Hispanic Caribbean: a systematic review

Introduction: Pertussis in Latin America continues to cause periodic epidemics with substantial morbidity particularly among young children. The disease has persisted despite long-standing vaccination programs in the region. Areas covered: We conducted a systematic review to characterize the recent epidemiology of pertussis in Latin America and Hispanic Caribbean. We undertook a holistic approach and attempted to include all available data concerning pertussis that may explain the changing dynamics of the disease. Expert opinion: There are wide disparities in the reported annual incidence rates of pertussis both within and between countries in the region. General trends in pertussis incidence are difficult to ascertain due to the heterogeneity in the epidemiological data. Available data suggests that the disease burden has changed over the years such that now it predominantly affects those 10 Latin American countries currently recommend vaccination of pregnant women

Rotavírus e alergia alimentar: uma breve revisão sobre a doença e a importância da vacinação

Artigo produzido a partir da Nota Técnica SBIm sobre o tema, disponível em http://sbim.org.br/images/ files/nota-sbim-asbai-sbp-rotavirus08022017-v2.pdf.Sociedade Brasileira de Imunizações. São Paulo, SP, Brasil.Sociedade Brasileira de Imunizações. São Paulo, SP, Brasil.Sociedade Brasileira de Imunizações. São Paulo, SP, Brasil.Sociedade Brasileira de Imunizações. São Paulo, SP, Brasil.Sociedade Brasileira de Imunizações. São Paulo, SP, Brasil.Sociedade Brasileira de Imunizações. São Paulo, SP, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Sociedade Brasileira de Pediatria. Rio de Janeiro, RJ, Brasil.Associação Brasileira de Alergia e Imunologia. São Paulo, SP, Brasil.Associação Brasileira de Alergia e Imunologia. São Paulo, SP, Brasil.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Ananindeua, PA, Brasil.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Ananindeua, PA, Brasil.Os questionamentos sobre a utilização da vacina rotavírus são frequentes, tanto da parte de médicos quanto de pacientes. As principais dúvidas são sobre a eficácia e segurança da vacina. Porém, os casos de crianças com quadros de alergia alimentar também despertam a atenção, em especial quando há diagnóstico ou suspeita de alergia à proteína do leite de vaca (APLV). Com o objetivo de esclarecer e orientar o profissional da Saúde, especialmente o pediatra, para uma adequada prescrição, os departamentos científicos de imunizações e alergia das sociedades brasileiras de Imunizações (SBIm), de Alergia e Imunologia (Asbai) e de Pediatria (SBP), além do Instituto Evandro Chagas, produziram uma breve revisão sobre a doença por rotavírus, as vacinas hoje licenciadas e a importância de sua utilização, além de comentários sobre alergia alimentar