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

Exploring the experience of chronic pain among female Survival Sex Workers : a qualitative study

Background The prevalence of self-identified chronic pain in Canadian adults is approximately one in five people. Marginalization and addictions have been shown to complicate chronic pain in vulnerable populations. This study aimed to understand the experience of chronic pain among female Survival Sex Workers in Vancouver's downtown eastside (DTES). Methods This study used an exploratory qualitative analysis with in-depth, semi-structured interviews. Members of PACE Society who self-identified as a current or former Survival Sex Worker and who had a chronic pain experience known to PACE support workers were invited to participate. Interviews were conducted, audio recorded and transcribed. The investigators met to read the transcripts and discuss emerging themes. The process continued until no new themes were observed. Results Participants ranged in age from 42 to 56 years old and all self- identified as females and Survival Sex Workers. Eleven of thirteen interviews were analyzed for themes. Drug use for pain management, both prescribed and illicit, was the most important theme. Poverty, the need to continue working and the lack of stable housing were barriers to adequately addressing the source of chronic pain. Participants felt judged for living in the downtown eastside, being a drug user and/or being Aboriginal and only two participants had been referred to a pain specialist. All participants were involved in support networks made up of other Sex Workers and all spoke of a sense of community and survival. Conclusions Our study emphasizes the complex nature of chronic pain and addictions among a uniquely marginalized population. The study is unique in that it contributes the perspectives of a traditionally “hard-to-reach” population and demonstrates that Sex Workers should not only participate in but should lead development and implementation of research and programs for managing chronic pain in the setting of addiction.Medicine, Faculty ofNon UBCFamily Practice, Department ofReviewedFacultyGraduateOthe

Intersecting structural barriers to reporting violence among men and non-binary sex workers under end-demand criminalization in Canada

A growing body of evidence indicates that sex work criminalization is linked to increased risk of violence and undermines the occupational health and safety (OHS) of sex workers. However, less is known about men and non-binary sex workers’ (MNBSWs) experiences with workplace violence and police-based systems for reporting violence under end-demand criminalization. To address this gap, we conducted 21 semi-structured interviews with MNBSWs in British Columbia between 2020 and 2021. Analysis drew on structural determinants of health and intersectionality frameworks. Most participants described sex work as not inherently dangerous. When participants experienced workplace violence, many described feeling morally obligated to report these incidents to protect others. However, participants experienced barriers to reporting violence to police due to intersecting sex work and substance use criminalization and stigmatization, anti-Indigenous racism, anti-poverty stigma, homophobia, transphobia, and gender stereotypes. Participants further described the need for gender-inclusive community-based systems of reporting violence against sex workers. Our findings demonstrate how intersecting forms of criminalization, stigmatization, and discrimination prevent MNBSWs from reporting workplace violence. Along with calls to decriminalize sex work and substance use, these findings highlight the need to develop community-based systems for reporting violence that account for intersecting identities, including gender, to improve OHS conditions for MNBSWs

Digital Exclusion and the Structural Barriers to Safety Strategies among Men and Non-Binary Sex Workers Who Solicit Clients Online

Background: Evidence shows that online solicitation facilitates sex workers’ ability to mitigate the risk of workplace violence. However, little is known about how end-demand sex work criminalization and the regulation of online sex work sites shape men and non-binary sex workers’ ability to maintain their own safety while soliciting services online. Methods: We conducted 21 semi-structured interviews with men and non-binary sex workers in British Columbia between 2020–2021 and examined their ability to enact safety strategies online in the context of end-demand criminalization. Analysis drew on a structural determinants of health framework. Results: Most participants emphasized that sex work is not inherently dangerous and described how soliciting services online facilitated their ability to enact personal safety strategies and remain in control of client interactions. However, participants also described how end-demand criminalization, sex work stigma, and restrictive website policies compromise their ability to solicit services online and to enact safety strategies. Conclusions: Alongside calls to decriminalize sex work, these findings emphasize the need to normalize sex work as a form of labour, promote access to online solicitation among men and non-binary sex workers, and develop standards for online sex work platforms in partnership with sex workers that prioritize sex worker safety.Graduate and Postdoctoral StudiesMedicine, Faculty ofNon UBCMedicine, Department ofPopulation and Public Health (SPPH), School ofReviewedFacultyResearcherOthe

Cardiovascular Health by Life\u27s Essential 8 and Associations With Coronary Artery Calcium in South Asian American Adults in the MASALA Study

South Asian Americans experience high cardiovascular disease risk. We evaluated the distribution and correlates of cardiovascular health (CVH) summarized by the Life\u27s Essential 8 (LE8) score among South Asian adults. In participants of the MASALA (Mediators of Atherosclerosis in South Asians Living in America) study, the association of demographic, social, and cultural factors with LE8 score was evaluated with t tests and analysis of variance. The association of LE8 score with coronary artery calcium (CAC) was evaluated with adjusted logistic regression. There were 556 women (mean age 55.9 years [SD 8.7], mean LE8 score 67.2 (SD 12.6) and 608 men (mean age 57.5 years [SD 9.9], mean LE8 score 61.9 (SD 13.1). Among women and men, the LE8 CVH score was higher in participants with higher annual family income, higher educational attainment, and fewer depressive symptoms. Overall, there was 26% lower odds of any CAC for each 10-point higher LE8 score (odds ratios [OR] 0.74, 95% confidence intervals [CI] 0.66 to 0.83), with similar magnitude of association in women and men. Participants with a high LE8 CVH score had 82% lower odds of CAC (OR 0.18, 95% CI 0.09 to 0.33), and participants with an intermediate LE8 CVH score had 38% lower odds of CAC (OR 0.62, 95% CI 0.41 to 0.94) than did participants with a low LE8 CVH score, with similar findings stratified by gender. In conclusion, in this cohort of South Asian Americans, most adults had suboptimal CVH assessed by the LE8 score. Higher LE8 score correlated with lower odds of any CAC

Association between dairy product intake and body composition among South Asian adults from the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study

South Asians, who are at a disproportionately greater risk of atherosclerotic CVD (ASCVD), represent a rapidly growing population in the USA. The relationship between dairy products, a major component of South Asian diets, and body composition - an established risk factor for ASCVD, is unclear. The aim of the present study was to examine associations between dairy intake and multiple measures of body composition (BMI, waist and hip circumference, waist:hip ratio, abdominal lean mass, subcutaneous, visceral, and intermuscular fat areas) among South Asian adults in the USA. A baseline analysis was conducted using existing data from the Mediators of Atherosclerosis in South Asians Living in America cohort. In women, the highest (>1·9 servings/d) v. lowest (<1 serving/d) tertile of dairy intake was associated with 53 % lower odds of a waist circumference >80 cm (95 % CI 0·25, 0·89, Pfor trend<0·05). No associations were observed between dairy intake and measures of body composition. However, >3 servings of low-fat yogurt/week was associated with a 9·9 cm2 lower visceral fat area (95 % CI -19·07, -0·72, P<0·05) and 2·3 cm2 lower intermuscular fat area (95 % CI -3·76, -0·79, P<0·05) as compared with those with three servings/week. Milk and cheese were not associated with body composition measures. These analyses suggest that higher consumption of low-fat yogurt is associated with lower visceral and intermuscular fat in the whole sample, and women with higher dairy intake have lower waist circumference. Our study supports dietary incorporation of dairy products, and recognises the utility of multidimensional measures of central adiposity

Concordance between Dash Diet and Hypertension: Results from the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study

High blood pressure is an important predictor of atherosclerotic cardiovascular disease (ASCVD), particularly among South Asians, who are at higher risk for ASCVD when compared to other population groups. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is established as the best proven nonpharmacological approach to preventing hypertension in adults. Using data from the Mediators of Atherosclerosis in South Asians Living in America (MASALA) cohort, we calculated a DASH dietary score to examine the association between adherence to the DASH diet and its components, and prevalent and incident hypertension and systolic and diastolic blood pressure, after five years of follow-up. We found that the relative risk ratio (RRR) of incident hypertension was 67% lower among participants in the highest DASH diet score category (aRRR: 0.33; 95% CI: 0.13, 0.82; p = 0.02) compared with those in the lowest DASH diet score category in fully adjusted models. These findings are consistent with previous clinical trials and large prospective cohort studies, adding to evidence that supports the diet-disease relationship established between DASH diet and hypertension. This study is the first to examine DASH diet adherence and hypertension among South Asian adults in the U.S