Factors associated with unexplained sudden deaths among adults aged 18-45 years in India - A multicentric matched case-control study.

BACKGROUND OBJECTIVES: In view of anecdotal reports of sudden unexplained deaths in India's apparently healthy young adults, linking to coronavirus disease 2019 (COVID-19) infection or vaccination, we determined the factors associated with such deaths in individuals aged 18-45 years through a multicentric matched case-control study. METHODS: This study was conducted through participation of 47 tertiary care hospitals across India. Cases were apparently healthy individuals aged 18-45 years without any known co-morbidity, who suddenly (<24 h of hospitalization or seen apparently healthy 24 h before death) died of unexplained causes during 1 st October 2021-31 st March 2023. Four controls were included per case matched for age, gender and neighborhood. We interviewed/perused records to collect data on COVID-19 vaccination/infection and post-COVID-19 conditions, family history of sudden death, smoking, recreational drug use, alcohol frequency and binge drinking and vigorous-intensity physical activity two days before death/interviews. We developed regression models considering COVID-19 vaccination ≤42 days before outcome, any vaccine received anytime and vaccine doses to compute an adjusted matched odds ratio (aOR) with 95 per cent confidence interval (CI). RESULTS: Seven hundred twenty nine cases and 2916 controls were included in the analysis. Receipt of at least one dose of COVID-19 vaccine lowered the odds [aOR (95% CI)] for unexplained sudden death [0.58 (0.37, 0.92)], whereas past COVID-19 hospitalization [3.8 (1.36, 10.61)], family history of sudden death [2.53 (1.52, 4.21)], binge drinking 48 h before death/interview [5.29 (2.57, 10.89)], use of recreational drug/substance [2.92 (1.1, 7.71)] and performing vigorous-intensity physical activity 48 h before death/interview [3.7 (1.36, 10.05)] were positively associated. Two doses lowered the odds of unexplained sudden death [0.51 (0.28, 0.91)], whereas single dose did not. INTERPRETATION CONCLUSIONS: COVID-19 vaccination did not increase the risk of unexplained sudden death among young adults in India. Past COVID-19 hospitalization, family history of sudden death and certain lifestyle behaviors increased the likelihood of unexplained sudden death.

Prevalence and antimicrobial resistance of Escherichia coli and Salmonella spp. in animal feed in Colombia.

Objective: To determine the prevalence and antimicrobial resistance of Escherichia coli and Salmonella spp. in animal feed samples collected between 2018 and 2021 in Colombia. Methods: This was a laboratory-based cross-sectional study using routine data from the program for inspection, surveillance, and control of animal feed at the Colombian Agriculture Institute. Samples of animal feed for swine, poultry, canine, feline, leporine, piscine, and equine species were processed for detection of E. coli and Salmonella spp. using enrichment and selective culture methods. Isolates were tested for antimicrobial susceptibility using an automated microdilution method. Results: Of 1 748 animal feed samples analyzed, 83 (4.7%) were positive for E. coli and 66 (3.8%) for Salmonella spp. The presence of E. coli and Salmonella spp. was highest in feed for poultry (6.4% and 5.5%) and swine (6.1% and 4.3%). Antimicrobial resistance testing was performed in 27 (33%) E. coli isolates and 26 (39%) Salmonella isolates. Among E. coli, resistance was most frequently observed to ampicillin (44.5%) followed by cefazolin (33.3%), ciprofloxacin (29.6%), ampicillin/sulbactam (26%), and ceftriaxone (11.1%). The highest resistance levels in Salmonella spp. isolates were against cefazolin (7.7%) and piperacillin/tazobactam (7.7%). Conclusions: This is the first study from Colombia reporting on the prevalence and antimicrobial resistance of E. coli and Salmonella spp. in animal feed samples. Its results establish a baseline over a wide geographical distribution in Colombia. It highlights the need to integrate antimicrobial resistance surveillance in animal feed due to the emergence of resistant bacteria in this important stage of the supply chain.

Multidrug-resistant Salmonella spp. in fecal samples of pigs with suspected salmonellosis in Antioquia, Colombia, 2019-2021.

Objectives: To determine the proportion of Salmonella enterica in fecal samples of live pigs with suspected salmonellosis analyzed at the diagnostic unit of the University of Antioquia, Colombia between 2019 and 2021, and examine the serotypes and antimicrobial resistance patterns. Methods: This was a laboratory-based cross-sectional study of routine data on fecal samples received from pig farms in all nine subregions of Antioquia state, Colombia. Salmonella spp. detection at the university is done using enrichment, selective culture, and polymerase chain reaction. Serotypes were identified using the Kauffmann-White scheme and isolates were tested for antimicrobial susceptibility using broth microdilution. Results: Of 653 samples tested, 149 (23%) were positive for S. enterica. Nine serotypes were identified. The most common were Salmonella Typhimurium (56%) and its monophasic variant (35%). Resistance to ampicillin (70%) was most frequently observed, followed by ciprofloxacin (55%), and sulfamethoxazole-trimethoprim (52%). No isolates were resistant to amikacin and gentamicin. Multidrug resistance (resistance to ≥ 3 classes of antibiotics) was observed in 61 (44%) isolates. Multidrug resistance was highest in S. Typhimurium (57%) compared with the other serotypes. Serotype was associated with multidrug resistance (p = 0.01), but age of the pig and sub-region were not. Conclusions: The proportion of Salmonella spp. and the associated high levels of multidrug resistance are of concern and may indicate irrational use of antimicrobials and poor management practices in pig production systems in the region. Strengthened surveillance is needed to monitor and improve farm management practices and the use of antimicrobials in farms in Colombia.

'We are not aware of notification of tuberculosis': A mixed-methods study among private practitioners from western India.

BACKGROUND: Implementing the Standards for tuberculosis care in India (STCI) guidelines in the private sector is vital. This study attempted to estimate the knowledge and practices regarding STCI guidelines among private practitioners and to explore the reasons and solutions for low tuberculosis (TB) notification rates. METHODS: We conducted a cross-sectional study for assessing the knowledge and practices of the STCI guidelines among 100 full-time allopathic private practitioners in Bhavnagar (in western part of India) from September 2018 to January 2019. Knowledge and practice were categorised as good or poor by assigning scores to the responses to a questionnaire based on the STCI guidelines. It was followed by two focus group discussions to explore the reasons and solutions for low notification rates of TB as perceived by private practitioners. RESULTS: Among the 100 private practitioners, 55% had good knowledge, and 41% had good practice regarding the STCI guidelines; 69% knew about the gazette notification of mandatory notification of TB, and 58% were notifying TB cases to the government. Lack of awareness about the process as well as incentives for notification, time constraints and infrequent visits by health workers were the main reasons perceived by private practitioners for not notifying TB cases to the government. The critical solutions suggested by them were creating awareness regarding the notification process as well as incentives, increasing health worker visits and use of social media for notification. CONCLUSION: Only about half of private practitioners follow the STCI guidelines for TB care, and the notification rates are low in our setting. Regular sensitisation programs need to be arranged for private practitioners to create awareness on TB notification.

A structured mentorship program for medical college faculty on health research.

BACKGROUND: A paradigm shift is required in faculty development programs on research skills, from theory-driven to hands-on practical approach. The objective of this study was to develop and implement a structured mentorship model for training of medical faculties in research skills. METHODS: An interventional study using functional mentorship and experiential learning based on a research project was conducted over a period of one year through two prevalidated modules: protocol and manuscript writing. We included early and mid-career medical faculty as mentees (mentor:mentee ratio-1:2). Module 1 consisted of eight days of active learning and 25 days of refinement period-the end point being submission of research proposal to the ethics committee. Module 2 consisted of six days of active learning and 15 days of refinement period with the end point being manuscript submission to a peer-reviewed journal. Context, Input, Process and Product model of evaluation was used for this program. RESULTS: All eight faculty who participated as mentees in this program completed the first module, developed protocols under this program and processed them through the ethics committee. Six of the eight participants of this original cohort attended the second module and five could submit their manuscript to a peer-reviewed journal within the stipulated date. Participants expressed improvement in their self-rating of research skills, satisfaction with the program and an overall favourable change in attitude towards research. CONCLUSION: Structured mentorship program with the help of local mentors could enhance research skills of medical faculty.

"Side effects--part of the package": a mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India.

BACKGROUND: High rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs. METHODS: This mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staff (treatment supervisors, medical officer and district program managers). RESULTS: Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. CONCLUSION: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems is the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.

Prevalence of risk factors and estimation of 10-year risk for cardiovascular diseases among male adult population of Tamil Nadu India-an insight from the National Family Health Survey-5.

OBJECTIVE: Cardiovascular diseases (CVD) are one of the most addressed preventable diseases of public health importance. However, the risk estimates and use of these risk scores for CVD prevention are the least explored areas. So, in this study, we explored the different categories of Framingham heart study (FHS) 10-year-CVD risk score and their associated factors among the adult male population in Tamil Nadu, India. METHODS: We used the risk factor level data for male adults aged 18 years and above from the National Family Health Survey (NFHS-5) of Tamil Nadu state, India. Sociodemographic variables, behavioral factors, and physiological/biochemical factors were considered as the risk factor and were estimated using the world health organization (WHO) STEPS categories. FHS 10-year-CVD risk score was calculated using a body-mass index-based published Cox regression equation. RESULTS: Out of 2289 adult males, only 1.12% of the participants had a 10-year CVD risk score greater than 30% and ∼4% of the total participants require statin treatment (FRS-CVD risk score ≥20). Educational status (aOR:14.21, 95 CI: 4.36-46.22- no formal schooling when compared to 10th and above standard), weekly fruit intake (aOR:0.51, 95 CI: 0.27-0.97 when compared to daily fruit intake) and abdominal obesity (aOR:2.43, 95 CI: 1.58-3.74) were found to be associated with higher FRS scores when adjusted for all other factors not involved in FRS calculation. CONCLUSION: Widespread use of this score needs to be encouraged in clinical practices and patients with a higher risk of CVD events should be counselled for lifestyle modifications and compliance with treatment for decreasing the burden due to CVDs.

Effects of Ultrasound-Guided Lower Extremity Nerve Blocks for Below-Knee Procedures in the Emergency Department of a Tertiary Care Hospital, Central Gujarat.

Background and objectives Ultrasound-guided femoral and popliteal sciatic nerve blocks are useful adjuncts for many below-knee procedures like debridement, amputation, etc. The objectives of the study were to find the efficacy and feasibility of the ultrasound-guided combined femoral and popliteal sciatic nerve block for below-knee procedures in the Emergency Medicine Department (ED). Methodology This prospective clinical study was carried out over three months in ED. A total of 30 patients undergoing below-knee procedures were included in the study. Femoral and popliteal sciatic nerve blocks were administered to each patient using the high-frequency linear ultrasound probe by emergency physicians trained in ultrasound. The effect of blocks, amount of local anesthetic (LA) used, duration of the procedure, and post-block analgesia were recorded. Patients were monitored for possible complications, if any. Data were entered and analyzed using a Microsoft Excel worksheet. Results The average volume of LAs required was around 34.5 cc for both blocks combined. No complications like vascular puncture or nerve injury were reported during the study. The time taken to complete the procedure was around 33 minutes, and the average time to achieve sensory block was around 9 minutes after completing the procedure. Conclusions An ultrasound-guided combined femoral and popliteal sciatic nerve block is an effective and feasible procedure and thus should be considered in ED for below-knee procedures.

Outcomes and Challenges in the Programmatic Implementation of Tuberculosis Preventive Therapy among Household Contacts of Pulmonary TB Patients: A Mixed-Methods Study from a Rural District of Karnataka, India.

The National TB Elimination Programme (NTEP) of India is implementing tuberculosis preventive treatment (TPT) for all household contacts (HHCs) of pulmonary tuberculosis patients (index patients) aged <5 years and those HHCs aged >5 years with TB infection (TBI). We conducted an explanatory mixed-methods study among index patients registered in the Kolar district, Karnataka during April-December 2022, to assess the TPT cascade and explore the early implementation challenges for TPT provision. Of the 301 index patients, contact tracing home visits were made in 247 (82.1%) instances; a major challenge was index patients' resistance to home visits fearing stigma, especially among those receiving care from the private sector. Of the 838 HHCs, 765 (91.3%) were screened for TB; the challenges included a lack of clarity on HHC definition and the non-availability of HHCs during house visits. Only 400 (57.8%) of the 692 eligible HHCs underwent an IGRA test for TBI; the challenges included a shortage of IGRA testing logistics and the perceived low risk among HHCs. As HHCs were unaware of their IGRA results, a number of HHCs actually eligible for TPT could not be determined. Among the 83 HHCs advised of the TPT, 81 (98%) initiated treatment, of whom 63 (77%) completed treatment. Though TPT initiation and completion rates are appreciable, the NTEP needs to urgently address the challenges in contact identification and IGRA testing.

Test and Treat Model for Tuberculosis Preventive Treatment among Household Contacts of Pulmonary Tuberculosis Patients in Selected Districts of Maharashtra: A Mixed-Methods Study on Care Cascade, Timeliness, and Early Implementation Challenges.

Tuberculosis preventive treatment (TPT) is an important intervention in preventing infection and reducing TB incidence among household contacts (HHCs). A mixed-methods study was conducted to assess the "Test and Treat" model of TPT care cascade among HHCs aged ≥5 years of pulmonary tuberculosis (PTB) patients (bacteriologically/clinically confirmed) being provided TPT care under Project Axshya Plus implemented in Maharashtra (India). A quantitative phase cohort study based on record review and qualitative interviews to understand the challenges and solutions in the TPT care cascade were used. Of the total 4181 index patients, 14,172 HHCs were screened, of whom 36 (0.3%) HHCs were diagnosed with tuberculosis. Among 14,133 eligible HHCs, 10,777 (76.3%) underwent an IGRA test. Of them, 2468 (22.9%) tested positive for IGRA and were suggested for chest X-ray. Of the eligible 2353 HHCs, 2159 (91.7%) were started on TPT, of whom 1958 (90.6%) completed the treatment. The median time between treatment initiation of index PTB patient and (a) HHC screening was 31 days; (b) TPT initiation was 64 days. The challenges in and suggested solutions for improving the TPT care cascade linked to subthemes were tuberculosis infection testing, chest X-ray, human resources, awareness and engagement, accessibility to healthcare facilities, TPT drugs, follow-up, and assessment. A systematic monitoring and time-based evaluation of TPT cascade care delivery followed by prompt corrective actions/interventions could be a crucial strategy for its effective implementation and for the prevention of tuberculosis.

Hypertension and its association with body mass index among the Indian population. Findings from a nationwide survey (NFHS-4), 2015-16.

Background: Globally, hypertension (HTN) and obesity are two cardinal causes of morbidity and mortality. The Asian population shows comorbidities associated with obesity at a much lower body mass index (BMI) than the western population. Aim: The primary objective of the present study was to evaluate the association between BMI and HTN among the adult population. Material and Methods: We did a cross-sectional secondary data analysis of the NFHS-4 datasets, conducted during 2015-16. We included the adult population, that is, ≥19 years of age (93,040 men and 5,46,066 women), and excluded adolescents and pregnant women from our analysis. HTN was the primary dependent variable, while BMI was the primary predictor variable. Other covariates included age, education, place of residence, wealth index, use of alcohol and tobacco, and diabetes. Weighted analysis was done to depict our results. Results: Around 18.7% of men and 13.5% of women were hypertensive, of which 53.86% of males and 38.7% females were either overweight or obese. The odds of living with HTN among obese men and women increased with age, wealth, use of alcohol and tobacco, and comorbidities such as diabetes. The prevalence of HTN was higher even among the underweight adults living with diabetes and those consuming alcohol and tobacco. Conclusion: We reaffirm the significant association between BMI and HTN among adults. The use of the Asian classification of BMI for India and its neighboring countries to assess the burden of obesity would help in planning better interventions. A community-based targeted approach would help in controlling and reducing the prevalence of HTN.

Gender-specific factors associated with hypertension among women of childbearing age: Findings from a nationwide survey in India.

Background: The association of conventional (modifiable and non-modifiable) risk factors for hypertension has already been established in the literature. However, there are other putative risk factors specific to women (early menarche, age at first childbirth, women empowerment, number of children born, hysterectomy, etc.) in the development of hypertension. This study is the first study to highlight the potential association of gender-specific factors along with other conventional risk factors and hypertension, using a nationwide sample. Methods: The study is a secondary analysis of the data collected from the National Family Health Survey-4 (NFHS-4), a nationally representative sample of 699,686 women of reproductive age in India. The interview schedule included data on general background characteristics, marriage, reproductive history, hysterectomy, knowledge, and utilization of family planning services, maternal and child care, women empowerment, non-communicable diseases, and domestic violence. The blood pressure was measured by direct observation by the study investigators using a digital blood pressure monitor. To account for disproportionate sampling and non-response, a weighted statistical analysis was performed. Logistic regression analysis was done to study the strength of the association between the risk factors and hypertension (computation of unadjusted and adjusted odds ratio). Results: The prevalence of hypertension was 11.8% among women. Among the conventional factors, older age, higher body mass index (BMI), tobacco use, and alcohol use had higher odds for hypertension, while higher education, higher socio-economic position, and living in urban areas had lower odds. Among the gender-specific factors, younger age at first childbirth, early menarche, oral contraceptive pill use [adjusted OR: 1.23; (1.18-1.28)], and hysterectomy [adjusted OR: 1.10; (1.05-1.69)] were found to be risk factors for hypertension. Domestic violence was significantly associated with hypertension [unadjusted OR: 1.11; (1.02-1.20)]. Empowered women had lower odds of hypertension [adjusted OR: 0.93; (0.95-1.03)]. Conclusion: Significant association of these gender-specific factors among women necessitates the need for taking into account these factors while screening for hypertension among women and thus, designing a tailored model better suited to them for risk assessment.

Screening Vaccinees for Non-Communicable Diseases and Risk Factors at a Covid-19 Vaccination Center in Vadodara, Gujarat.

Context: Adult population visiting COVID vaccination center is a potential teachable moment for screening and preventive advice on non-communicable diseases. Objectives: The objective of this study was to assess the proportion of vaccinees volunteering for screening and to know the proportion of newly detected hypertensives and diabetics among the screened vaccinees at COVID-19 vaccination center. Setting and Design: This descriptive, cross-sectional, operational research study was carried out at the COVID vaccination center at a medical college in central Gujarat from July to September 2021. Methods: After receiving the vaccine, the vaccinee was offered screening through a community-based assessment checklist for risk factors of non-communicable diseases, blood pressure, and blood sugar measurement. Those volunteering for this screening received a slip mentioning their risk score, blood pressure and blood sugar reading, and relevant health information and disease prevention advice. The study variables were acceptability (proportion of vaccinees volunteering for screening) and yield (newly detected hypertensives and diabetics among those screened). Results: Among vaccinees, 27.7% volunteered for risk scoring and blood pressure measurement, whereas 8.3% volunteered for blood sugar measurement. Around 15.5% of vaccinees had high-risk scores as per the community-based assessment checklist. The yield of freshly detected high blood pressure and high blood sugar was 19.3% and 10.5%, respectively. The yield was similar even among vaccinees under 30 years of age. Conclusions: Vaccinees demonstrated interest in undergoing screening for non-communicable diseases. Yield indicates that such screening is worth the effort.

Screening adults with tuberculosis for severe illness at notification: programme experience from Gujarat, India.

BACKGROUND: National tuberculosis (TB) programmes in high-burden countries do not systematically assess severity at diagnosis followed by referral for inpatient care. Due to limited capacity, comprehensive assessment of all TB patients is not practical. In three districts of Gujarat (West India) in June 2021, we determined the feasibility of screening for severe illness by paramedical staff of public facilities and the burden of 'high risk for severe illness' at notification among adults (≥15 y of age) with TB. METHODS: In this cross-sectional study, the screening criteria for high risk for severe illness was the presence of any one of the following: body mass index (BMI) ≤14.0 kg/m2, BMI ≤16.0 kg/m2 with bilateral leg swelling, respiratory rate >24/min, oxygen saturation <94% or inability to stand without support. We summarized the feasibility indicators and burden using proportion (95% confidence interval [CI]) and median, as applicable. RESULTS: Of 626 notified adults, 87% were screened. The median time interval for screening was 3 d from notification and all indicators were collected in 97% of patients. The burden of high risk for severe illness was high, at 41.6% (95% CI 37.5 to 45.8). CONCLUSIONS: High burden and feasibility (high coverage, acceptable time interval and minimal missing data) makes a strong case for routine screening of severe illness.

Dietary salt consumption pattern as an antecedent risk factor for hypertension: Status, vision, and future recommendations.

Multiple salt reduction strategies have been devised from time to time, addressing the issues of hypertension without considering the other essential factors, like the variability of salt sensitivity from the person to person. In this paper, we discuss how high salt consumption is one modifiable risk factor associated with hypertension among Indians, and there needs to be updated cut-off values. A thorough literature search on salt consumption articles on well-known search engines like Cochrane Library, PubMed, Google Scholar and Embase electronic database revealed a paucity of data in this field for India. Several studies revealed that the mean salt intake among the Indian populations ranges between 5.22 and 42.30 g/day. Moreover, among other risk factors analysed, salt intake (≥ 5 gm/day) was significantly associated with the development of hypertension. Although the need to address reduced salt intake for primordial prevention of hypertension and related cardiovascular diseases (CVDs) in India is well acknowledged by the key stakeholders, social and cultural beliefs, unorganized food retail sector and lack of existing food policing are some of the potential barriers that affect the progress and employment of such effective strategies. Some multinational food companies have already research is warranted to evaluate the contextual barriers and facilitators and to adopt effective strategies to improve awareness among consumers, to encourage the endorsement of salt reduction by the food industry, and to facilitate the adoption of countrywide consumer-friendly food labelling. We concluded that salt consumption is high in India, although this assessment has been done primarily by subjective methods in India. People all across are recommended the same cut-off value of dietary salt consumption regardless of the diversity in dietary patterns and environmental conditions across the country. There is an urgent need to address these issues through evidence-based population research.

Role of vaccine science diplomacy in low-middle-income countries for eradicating the vaccine-preventable diseases: Targeting the "LAST MILE".

The meaning of "vaccine diplomacy (VD)" is defined as "the use of vaccines to increase a country's diplomatic relations and influence over other nations." The golden era of vaccine science diplomacy started during the time of Cold War between the United States (US) and the Union of Soviet Socialist Republics (USSR) with the development of a prototype of oral polio vaccine by the US Scientist Dr Albert Sabin working along with his Soviet counterparts. The foundation stone was already laid down by Edward Jenner when he shared his technique of the smallpox vaccine with other major countries to curb the spread of smallpox. Eventually, such a step led to the eradication of such a deadly disease. Only time has changed, not the tide. Even today, vaccines continue to remain as one of the important tools for achieving Millennium Developmental Goals (MDGs) and other targets in developing countries like India. During the wake of the Corona Virus Diseases-19 (COVID-19) pandemic, India's role in developing its vaccine science diplomacy has been a point of attraction. The phase-3 trial of Covaxin being developed by Bharat Biotech started in Lucknow and Gorakhpur in October 2020, and it is widely considered as the forerunner for the Indian vaccine market. As per the Union Health Ministry of India- "The Union Government is working on at least five distinct ways, ranging from free vaccines to guaranteed supply, in which it can help its immediate neighbours and countries in West Asia, Africa and even Latin America-officials familiar with the plan said on conditions of anonymity. The idea is to leverage the country's standing as the world's vaccine factory to merge diplomatic ties. Historically, it is observed that by the development and introduction of newer vaccines from time to time, many dismaying hurdles to vaccine science diplomacy (VSD) arise from ongoing wars and political instability. The current scenario is that both VSD and VD are at crossroads, and there is a possibility of getting a good direction if we make a piggyback policy approach of vaccine diplomacy along with the foreign policy. The lessons learned from the past must be followed now and, in the future, to make a better world for all. We acknowledge that the COVID-19 episode has again highlighted the dire need for VSD, and we assume that not only COVID-19 but in future, emerging and re-emerging diseases will occur so we have to prepare ourselves for combatting those future emerging and re-emerging diseases.

Expanded principles of ethics and its implementation during COVID-19 vaccine trials: A scoping evidence based research synthesis.

The COVID-19 pandemic will subside only through the emergence and distribution of an efficacious vaccine. The two main aspects that should be maintained in equilibrium: the dire necessity for speedy vaccine research and the need for safeguarding the research subjects, which is of utmost concern in research ethics. This opens up a discussion of what norms to follow during the clinical trials while developing the vaccine. As of now, various companies like Moderna, Pfizer, University of Oxford, Astra-Zeneca and so on have moved beyond the safety, efficacy and immunogenic studies. This narrative review explores and discusses the key principles of ethics: a principle of autonomy, beneficence, non-maleficence, and justice along with its ten general expanded principles. Furthermore, it delves into the different types of vaccines, their mechanisms, side effects, limitations, and advantages.

Efficacy and safety of colchicine in COVID-19: a meta-analysis of randomised controlled trials.

BACKGROUND: Colchicine, an anti-inflammatory drug is prescribed nowadays for COVID-19. In this meta-analysis, we evaluated efficacy and safety of colchicine in patients with COVID-19. METHODS: We searched databases for randomised controlled studies evaluating efficacy and/or safety of colchicine as compared with supportive care in patients with COVID-19. The efficacy outcomes were mortality, ventilatory support, intensive care unit (ICU) admission and length of hospital stay. The safety outcomes were adverse events, serious adverse events and diarrhoea. A meta-analytical summary was estimated using random effects model through Mantle-Hanzle method. An I2 test was used to assess heterogeneity. The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach was used to assess quality of evidence for each outcome. RESULTS: Out of 69 full texts assessed, 6 studies (16148 patients with COVID-19) were included in meta-analysis. Patients receiving colchicine did not show significant reduction in mortality (risk difference, RD -0.00 (95% CI -0.01 to 0.01), I2=15%), ventilatory support (risk ratio, RR 0.67 (95% CI 0.38 to 1.21), I2=47%), ICU admission (RR 0.49 (95% CI 0.19 to 1.25), I2=34%), length of hospital stay (mean difference: -1.17 (95% CI -3.02 to 0.67), I2=77%) and serious adverse events (RD -0.01 (95% CI -0.02 to 0.00), I2=28%) than those who received supportive care only. Patients receiving colchicine had higher rates of adverse events (RR 1.58 (95% CI 1.07 to 2.33), I2=81%) and diarrhoea (RR 1.93 (95% CI 1.62 to 2.29), I2=0%) than supportive care treated patients. The GRADE quality of evidence was moderate for most outcomes. CONCLUSION: The moderate quality evidence suggests no benefit of addition of colchicine to the standard care regimen in patients with COVID-19.