An Observational Study Comparing the Adverse Effect Profiles of Sputnik V and Covaxin COVID-19 Vaccines in Adult General Population of Eastern India

Aim : Currently no data is available on the safety profile of COVID-19 Vaccines like Covaxin and Sputnik V from Eastern India. Our aim was to evaluate the safety profiles of Covaxin and Sputnik V Vaccine in Eastern India. Methods : 0.5 ml of Covaxin and Sputnik V given to 701 adults in a two-dose regimen at a private tertiary care Hospital, Kolkata, with the doses separated by 4-7 weeks in Covaxin and 3 weeks in Sputnik V. Data regarding local and systemic Adverse Event Following Immunizations (AEFIs) was collected 30 minutes after vaccination and also on the first- and seventh-day following vaccination after each dosage. Results : Incidence of AEFI was 65% and 59% following the first dose of vaccination in Covaxin and Sputnik V groups, respectively. Incidence of AEFI was 83% and 70% after the second dose in Covaxin and Sputnik V groups. Pain in the injection site was the most common adverse effect. Body-ache, fever and tiredness were other systemic side effects. Adverse effects were noticeably more after the second dose. Over half of the reactions were mild in nature. Covaxin had a higher number of moderate adverse reactions after both doses. Adults with age >40 years, Comorbidities, Hypertension and Diabetes had a smaller number of side effects following the first dose of vaccination. People with previous COVID-19 infections had noticeably fewer adverse effects after the second dose. Allergic adults were associated with more systemic side effects, whereas Hypertensive adults had less total AEFI. Conclusion : Both Covaxin and Sputnik V had favorable safety profiles. Sputnik V vaccine had significantly fewer AEFIs compared to Covaxin. Age, co-morbidities, specifically hypertension, Diabetes, Allergy and previous history of COVID-19 infection, were important variables observed in the prevalence of side effects.

Original research paper a study of rational use of drugs among the ophthalmic-in-patients of a government teaching hospital in view of forensic pharmacology.

Inappropriate, irrational and cost-ineffective practices of pharmaceuticals are worldwide phenomena. A retrospective study was conducted among the Ophthalmic-in-patients to investigate the nature of utilization of drugs in respect of rationality correlating the clinical and forensic pharmacology. Prescriptions in the Bed Head Tickets were the study samples which were analyzed according to the WHO/INRUD Indicators. Incurred cost per day per prescription was calculated. Commonly prescribed drugs were also studied. Result revealed that proportion of drugs from Essential Medicines List (EML) was 51.62%, while 54.05% was prescribed by generic names. Most commonly prescribed drugs were antibiotics (100%), analgesic-anti-inflammatory agents (100%) and mydriatic-cycloplegic agents (91.98%). Average number of drugs per prescription was 4.03±1.5 and average cost per day per prescription was 99.22 INR (Indian Rupees). Injectables were prescribed in 97.36% cases, and 10.81% of total drugs (37) prescribed. Prescribing practices were not always in accordance with the WHO criteria for rational use of drugs. It is suggested that there is a felt need to provide more inputs to the Ophthalmologists to promote rational use of drugs.

High performance liquid chromatographic determination of cox-2 inhibitor rofecoxib in human plasma.

A convenient, sensitive and simple method for the determination of rofecoxib in human plasma is presented. The analytical technique is based on reversed phase high performance liquid chromatography coupled with UV detector (Knauer, Germany) set at 272 nm. The retention time of rofecoxib after recovery from plasma, was 8.9 minutes. The method has been validated over a linear range of 50-450 ng/ml from plasma. After validation the method was used to study the pharmacokinetic profile of rofecoxib in 6 healthy volunteers as per DCGI guidelines after administration of a single oral dose (50 mg). The extraction efficiency from plasma varied from 93.95-99.58%. The minimum quantifiable concentration was set at 50 ng/ml (% CV < 10%). The pharmacokinetic parameters were Cmax = 318.58 +/- 30.65 ng/ml at tmax = 2.66 +/- 0.25 hours, AUC0-t = 4007.88 +/- 438.32 ng hour/ml, AUC0-yen = 5454.66 +/- 822.29 ng hour/ml, Kel = 0.0433 +/- 0.0067/hour, and t1/2 = 16.36 +/- 2.89 hours.