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Background: Vaccination is the most important prophylactic measure taken to curb COVID-19 pandemics. This study was undertaken to throw light on the safety of Covishield vaccine among health care workers (HCWs) and to assess the co-variates associated with incidence of adverse events. Methods: This prospective observational study was conducted in a tertiary care center in South India as part of the HCW vaccination drive. All consenting HCWs who received the first dose of Covishield vaccine and developed ADRs were included in this study. After vaccination, all beneficiaries were monitored for AEFI for a period of half an hour and later followed up through telephone and google survey forms on day 2 and day 7 of vaccination. The data was subsequently collated into spreadsheet format and analyzed. Results: The study included 1264 consenting healthcare workers who were predominantly youth, aged 15–24 years (n = 583, 46 %) and with a female preponderance of 76 % (n = 960). Past history of COVID-19 infections was reported among 4.6 % (58) of the study population. Postvaccination symptoms were majorly reported during the first (40 %) and second day (44 %) after vaccination with a high prevalence of both local (n = 1083, 85 %) and systemic symptoms (n = 1065, 84 %). The mean duration of symptoms was observed to be 1.4 ± 0.81 days post vaccination. Symptoms were observed significantly high among females (76.7 %, p = 0.013). The prevalence of systemic (88 % vs 80 %) (p

Background: Safe and effective use of colistin requires robust pharmacokinetic (PK) and pharmacodynamic (PD) data to guide dosing. Aim: To evaluate the pharmacokinetics of colistimethate sodium and colistin in critically ill patients and correlate with clinical efficacy and renal function. Materials and Methods: Twenty critically ill adult patients with colistin-susceptible multidrug-resistant (MDR) infections and normal renal function treated with intravenous colistimethate sodium – at a 9 million units (270 mg CBA) loading dose followed by maintenance (MD) of 3 million units t.i.d, 24 hours later – were evaluated for clinical cure (CC) at the end of therapy. Patient characteristics and plasma colistin levels at 0, 0.5, 1, 2, 4, 8 and 12 hours after the loading dose and at 1, 2 and 8 hours after the eighth and ninth infusion of MD were evaluated. Colistimethate sodium and colistin levels were measured by high-performance liquid chromatography and tandem mass spectrometry (HPLC-MS/MS). Results: Among the 20 patients who were evaluated, 60% had pneumonia. Predominant pathogens were Klebsiella pneumoniae and Acinetobacter spp. Clinical cure was 50% (10/20). Mean peak loading dose concentrations were 3 ± 1.1 mg/L (1.75–5.14) and 2.37 ± 1.2 mg/L (1.52–5.54) for ‘cure’ and ‘failure’ groups, respectively (p = 0.13), while mean steady-state (Cssavg) concentrations were 2.25 ± 1.3 mg/L and 1.78 ± 1.1 mg/L in ‘cure’ and ‘failure’ groups, respectively (p = 0.19). Nephrotoxicity was 5% on day 7 of therapy. However, bacteriological cure could not be correlated with PK/PD. Conclusions: Subtherapeutic Cssavg with clinical failure and lower efficacy without significant nephrotoxicity highlights the need for therapeutic drug monitoring to guide colistin dosing.