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

Ensaios sobre as associações do consumo de cannabis com o índice CCEB, as preferências sobre a legalização e o desempenho universitário dos estudantes efetivamente matriculados

Submitted by Beatriz Machado ([email protected]) on 2020-01-09T17:33:29Z No. of bitstreams: 2 license_rdf: 914 bytes, checksum: f9944a358a0c32770bd9bed185bb5395 (MD5) Tese VFinal Com Ficha - Alvaro Mendes (8).pdf: 942880 bytes, checksum: ca2c8c629df2bf94f83eccc577ac8bca (MD5)Approved for entry into archive by Camila Silva ([email protected]) on 2020-01-10T19:29:00Z (GMT) No. of bitstreams: 2 license_rdf: 914 bytes, checksum: f9944a358a0c32770bd9bed185bb5395 (MD5) Tese VFinal Com Ficha - Alvaro Mendes (8).pdf: 942880 bytes, checksum: ca2c8c629df2bf94f83eccc577ac8bca (MD5)Made available in DSpace on 2020-01-16T20:09:42Z (GMT). No. of bitstreams: 2 license_rdf: 914 bytes, checksum: f9944a358a0c32770bd9bed185bb5395 (MD5) Tese VFinal Com Ficha - Alvaro Mendes (8).pdf: 942880 bytes, checksum: ca2c8c629df2bf94f83eccc577ac8bca (MD5) Previous issue date: 2018-04-09Esta tese pretende contribuir para o debate sobre a questão da melhor política pública possível para a Cannabis no Brasil a partir de quatro objetivos principais: (i) verificar as associações entre o índice socioeconômico CCEB e o consumo de Cannabis dos universitários brasileiros das capitais; (ii) analisar as associações do consumo crônico de Cannabis com a progressão dos alunos efetivamente matriculados em universidades brasileiras das capitais; (iii) apresentar uma discussão sobre as forças que conduzem os movimentos de legalização no ocidente; e (iv) examinar as associações de diferentes padrões de consumo com o suporte à legalização da maconha no Brasil. Com o intuito de responder às perguntas definidas foram empregadas revisões bibliográficas, estatísticas descritivas e regressões econométricas sobre as duas principais bases de usuários de drogas no Brasil, o 1° Levantamento Nacional sobre o Uso de Álcool, Tabaco e Outras Drogas entre Universitários das 27 Capitais Brasileiras e o 2° Levantamento Nacional de Álcool e Drogas (II LENAD) do INPAD/UNIFESP. As principais descobertas para cada um dos objetivos elencados, foram: (i) a Cannabis é a droga ilícita com a maior proporção de consumo recreativo nessa população. Além disso, indivíduos provenientes das classes A e B do critério CCEB estão associados a 120% mais chances de consumo de maconha nos últimos 12 meses quando comparados aos das classes C, D e E. (ii) Nossas melhores estimativas apontam que um risco moderado ou alto de dependência de Cannabis esteve associado a uma diminuição da probabilidade de passar direto em 4,9% no Modelo de Probabilidade Linear (MPL) e em 33,6% no MPL-VI. Nos modelos probit e probit bivariado, a redução verificada foi de 5,2% e 9,8%. As associações entre o consumo e um pior desempenho educacional foram negativas nos 20 modelos apresentados, sendo significativas ao nível de 10% em 13 deles. (iii) os usuários marginalizados; a subcultura da Cannabis; os usuários recreativos e dependentes; os especialistas pró-legalização e filantropia progressista; e a indústria da Cannabis seriam os principais agentes da expansão do suporte à legalização no Ocidente. (iv) O componente do autointeresse do consumo de Cannabis é o principal fator determinante para o suporte à legalização da substância no Brasil. Assim, os usuários recreativos estão associados a um risco 20,6 vezes maior de apoiar a legalização da maconha em relação aos não usuários.This thesis intends to contribute to the debate about the best public policy for Cannabis available in Brazil and has four main objectives: (i) to verify the associations between the socioeconomic index CCEB and the Cannabis consumption of the Brazilian university students; (ii) analyze the associations of chronic consumption of Cannabis with the progression of students actually enrolled in Brazilian universities; (iii) present a discussion of the forces driving legalization movements in the West; and (iv) to examine the associations of different patterns of consumption with the support to Cannabis legalization in Brazil. In order to answer the proposed objectives, bibliographical reviews, descriptive statistics and econometric regressions were applied to the two main databases of Brazilian drug users, the 1st Nationwide Survey on the Use of Alcohol, Tobacco and Other Drugs among College Students in the 27 Brazilian State Capitals of FM/USP and the 2nd National Survey on Alcohol and Drugs (II LENAD) of INPAD / UNIFESP. The main findings for each of the objectives listed were: (i) Cannabis is the illicit drug with the highest proportion of recreational consumption in this population. In addition, individuals from classes A and B of the CCEB index are associated with a 120% greater chance of marijuana use in the last 12 months when compared to classes C, D and E. (ii) Our best estimates indicate that a moderate or high risk of dependence on Cannabis was associated with a decrease in the probability of be approved in all disciplines (without take a final exam) on the Linear Probability Model (MPL) by 4.9% and in MPL-VI by 33.6%. In the probit and bivariate probit models, the reduction was 5.2% and 9.8%. The associations between consumption and worse educational performance were negative in the 20 presented models, being significant at the level of 10% in 13 of them. (iii) marginalized users; the Cannabis subculture; recreational and dependent users; the prolegalization experts and progressive philanthropic; and the Cannabis industry are the main supporters of legalization movements in the West. (iv) The self-interest component of Cannabis use is the main determining factor for legalization support of the substance in Brazil. Thus recreational users are associated with a 20.6 times greater risk of supporting marijuana legalization than non-users

NEOTROPICAL ALIEN MAMMALS: a data set of occurrence and abundance of alien mammals in the Neotropics

Biological invasion is one of the main threats to native biodiversity. For a species to become invasive, it must be voluntarily or involuntarily introduced by humans into a nonnative habitat. Mammals were among first taxa to be introduced worldwide for game, meat, and labor, yet the number of species introduced in the Neotropics remains unknown. In this data set, we make available occurrence and abundance data on mammal species that (1) transposed a geographical barrier and (2) were voluntarily or involuntarily introduced by humans into the Neotropics. Our data set is composed of 73,738 historical and current georeferenced records on alien mammal species of which around 96% correspond to occurrence data on 77 species belonging to eight orders and 26 families. Data cover 26 continental countries in the Neotropics, ranging from Mexico and its frontier regions (southern Florida and coastal-central Florida in the southeast United States) to Argentina, Paraguay, Chile, and Uruguay, and the 13 countries of Caribbean islands. Our data set also includes neotropical species (e.g., Callithrix sp., Myocastor coypus, Nasua nasua) considered alien in particular areas of Neotropics. The most numerous species in terms of records are from Bos sp. (n = 37,782), Sus scrofa (n = 6,730), and Canis familiaris (n = 10,084); 17 species were represented by only one record (e.g., Syncerus caffer, Cervus timorensis, Cervus unicolor, Canis latrans). Primates have the highest number of species in the data set (n = 20 species), partly because of uncertainties regarding taxonomic identification of the genera Callithrix, which includes the species Callithrix aurita, Callithrix flaviceps, Callithrix geoffroyi, Callithrix jacchus, Callithrix kuhlii, Callithrix penicillata, and their hybrids. This unique data set will be a valuable source of information on invasion risk assessments, biodiversity redistribution and conservation-related research. There are no copyright restrictions. Please cite this data paper when using the data in publications. We also request that researchers and teachers inform us on how they are using the data

NEOTROPICAL XENARTHRANS: a data set of occurrence of xenarthran species in the Neotropics

Xenarthrans—anteaters, sloths, and armadillos—have essential functions for ecosystem maintenance, such as insect control and nutrient cycling, playing key roles as ecosystem engineers. Because of habitat loss and fragmentation, hunting pressure, and conflicts with domestic dogs, these species have been threatened locally, regionally, or even across their full distribution ranges. The Neotropics harbor 21 species of armadillos, 10 anteaters, and 6 sloths. Our data set includes the families Chlamyphoridae (13), Dasypodidae (7), Myrmecophagidae (3), Bradypodidae (4), and Megalonychidae (2). We have no occurrence data on Dasypus pilosus (Dasypodidae). Regarding Cyclopedidae, until recently, only one species was recognized, but new genetic studies have revealed that the group is represented by seven species. In this data paper, we compiled a total of 42,528 records of 31 species, represented by occurrence and quantitative data, totaling 24,847 unique georeferenced records. The geographic range is from the southern United States, Mexico, and Caribbean countries at the northern portion of the Neotropics, to the austral distribution in Argentina, Paraguay, Chile, and Uruguay. Regarding anteaters, Myrmecophaga tridactyla has the most records (n = 5,941), and Cyclopes sp. have the fewest (n = 240). The armadillo species with the most data is Dasypus novemcinctus (n = 11,588), and the fewest data are recorded for Calyptophractus retusus (n = 33). With regard to sloth species, Bradypus variegatus has the most records (n = 962), and Bradypus pygmaeus has the fewest (n = 12). Our main objective with Neotropical Xenarthrans is to make occurrence and quantitative data available to facilitate more ecological research, particularly if we integrate the xenarthran data with other data sets of Neotropical Series that will become available very soon (i.e., Neotropical Carnivores, Neotropical Invasive Mammals, and Neotropical Hunters and Dogs). Therefore, studies on trophic cascades, hunting pressure, habitat loss, fragmentation effects, species invasion, and climate change effects will be possible with the Neotropical Xenarthrans data set. Please cite this data paper when using its data in publications. We also request that researchers and teachers inform us of how they are using these data

NEOTROPICAL CARNIVORES: a data set on carnivore distribution in the Neotropics

Mammalian carnivores are considered a key group in maintaining ecological health and can indicate potential ecological integrity in landscapes where they occur. Carnivores also hold high conservation value and their habitat requirements can guide management and conservation plans. The order Carnivora has 84 species from 8 families in the Neotropical region: Canidae; Felidae; Mephitidae; Mustelidae; Otariidae; Phocidae; Procyonidae; and Ursidae. Herein, we include published and unpublished data on native terrestrial Neotropical carnivores (Canidae; Felidae; Mephitidae; Mustelidae; Procyonidae; and Ursidae). NEOTROPICAL CARNIVORES is a publicly available data set that includes 99,605 data entries from 35,511 unique georeferenced coordinates. Detection/non-detection and quantitative data were obtained from 1818 to 2018 by researchers, governmental agencies, non-governmental organizations, and private consultants. Data were collected using several methods including camera trapping, museum collections, roadkill, line transect, and opportunistic records. Literature (peer-reviewed and grey literature) from Portuguese, Spanish and English were incorporated in this compilation. Most of the data set consists of detection data entries (n = 79,343; 79.7%) but also includes non-detection data (n = 20,262; 20.3%). Of those, 43.3% also include count data (n = 43,151). The information available in NEOTROPICAL CARNIVORES will contribute to macroecological, ecological, and conservation questions in multiple spatio-temporal perspectives. As carnivores play key roles in trophic interactions, a better understanding of their distribution and habitat requirements are essential to establish conservation management plans and safeguard the future ecological health of Neotropical ecosystems. Our data paper, combined with other large-scale data sets, has great potential to clarify species distribution and related ecological processes within the Neotropics. There are no copyright restrictions and no restriction for using data from this data paper, as long as the data paper is cited as the source of the information used. We also request that users inform us of how they intend to use the data