COVID-19 infection originated in Wuhan, China in December 2019 and crippled human health globally in no time. The public health emergency required urgent efforts to develop and test the efficacy and safety of vaccines to combat the COVID-19 pandemic. The emergency use approval has been granted to COVID-19 vaccines before the completion of conventional phases of clinical trials. However, there is no comprehensive review of safety data reported from the vaccine trials, which is critical information to inform the policies in order to improve uptake of COVID-19 vaccines and mitigate the risk aversion perceived due to the COVID-vaccine side effects. This study aims to systematically review and synthesize the evidence on the safety data from the published COVID-19 vaccine trials. This study followed PRISMA guidelines. We searched three major electronic databases (PubMed, Embase, and Google Scholar) for published studies between Dec 2019 and 2020. Eligible study designs were randomized trials and pre-and post-intervention evaluations. Descriptive findings of included studies were reported stratified by target population, setting, outcomes, and overall results. From PubMed, Embase, WHO database, and Google Scholar screened titles and abstracts, 11 studies were identified in this review. Most of the reactions reported were mild to moderate whereas a few with severe intensity. All reactions resolved within 3-4 days. The & Jaykaran Charan

National Heart, Lung, and Blood Institute and UnitedHealth Group.

Background People with chronic conditions are disproportionately prone to be affected by the COVID-19 pandemic but there are limited data documenting this. We aimed to assess the health, psychosocial and economic impacts of the COVID-19 pandemic on people with chronic conditions in India. Methods Between July 29, to September 12, 2020, we telephonically surveyed adults (n = 2335) with chronic conditions across four sites in India. Data on participants’ demographic, socio-economic status, comorbidities, access to health care, treatment satisfaction, self-care behaviors, employment, and income were collected using pre-tested questionnaires. We performed multivariable logistic regression analysis to examine the factors associated with difficulty in accessing medicines and worsening of diabetes or hypertension symptoms. Further, a diverse sample of 40 participants completed qualitative interviews that focused on eliciting patient’s experiences during the COVID-19 lockdowns and data analyzed using thematic analysis. Results One thousand seven hundred thirty-four individuals completed the survey (response rate = 74%). The mean (SD) age of respondents was 57.8 years (11.3) and 50% were men. During the COVID-19 lockdowns in India, 83% of participants reported difficulty in accessing healthcare, 17% faced difficulties in accessing medicines, 59% reported loss of income, 38% lost jobs, and 28% reduced fruit and vegetable consumption. In the final-adjusted regression model, rural residence (OR, 95%CI: 4.01,2.90–5.53), having diabetes (2.42, 1.81–3.25) and hypertension (1.70,1.27–2.27), and loss of income (2.30,1.62–3.26) were significantly associated with difficulty in accessing medicines. Further, difficulties in accessing medicines (3.67,2.52–5.35), and job loss (1.90,1.25–2.89) were associated with worsening of diabetes or hypertension symptoms. Qualitative data suggest most participants experienced psychosocial distress due to loss of job or income and had difficulties in accessing in-patient services. Conclusion People with chronic conditions, particularly among poor, rural, and marginalized populations, have experienced difficulties in accessing healthcare and been severely affected both socially and financially by the COVID-19 pandemic.

Background: The burden of noncommunicable diseases and their risk factors has rapidly increased worldwide, including in India. Innovative management strategies with electronic decision support and task sharing have been assessed for hypertension, diabetes mellitus, and depression individually, but an integrated package for multiple chronic condition management in primary care has not been evaluated. Methods: In a prospective, multicenter, open-label, cluster-randomized controlled trial involving 40 community health centers, using hypertension and diabetes mellitus as entry points, we evaluated the effectiveness of mWellcare, an mHealth system consisting of electronic health record storage and an electronic decision support for the integrated management of 5 chronic conditions (hypertension, diabetes mellitus, current tobacco and alcohol use, and depression) versus enhanced usual care among patients with hypertension and diabetes mellitus in India. At trial end (12-month follow-up), using intention-to-treat analysis, we examined the mean difference between arms in change in systolic blood pressure and glycated hemoglobin as primary outcomes and fasting blood glucose, total cholesterol, predicted 10-year risk of cardiovascular disease, depression score, and proportions reporting tobacco and alcohol use as secondary outcomes. Mixed-effects regression models were used to account for clustering and other confounding variables. Results: Among 3698 enrolled participants across 40 clusters (mean age, 55.1 years; SD, 11 years; 55.2% men), 3324 completed the trial. There was no evidence of difference between the 2 arms for systolic blood pressure (Δ=−0.98; 95% CI, −4.64 to 2.67) and glycated hemoglobin (Δ=0.11; 95% CI, −0.24 to 0.45) even after adjustment of several key variables (adjusted differences for systolic blood pressure: – 0.31 [95% CI, −3.91 to 3.29]; for glycated hemoglobin: 0.08 [95% CI, −0.27 to 0.44]). The mean within-group changes in systolic blood pressure in mWellcare and enhanced usual care were −13.65 mm Hg versus −12.66 mm Hg, respectively, and for glycated hemoglobin were −0.48% and −0.58%, respectively. Similarly, there were no differences in the changes between the 2 groups for tobacco and alcohol use or other secondary outcomes. Conclusions: We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02480062.