An Observational Study Comparing the Adverse Effect Profiles of Sputnik V and Covaxin COVID-19 Vaccines in Adult General Population of Eastern India
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Date
2022-08
Journal Title
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Publisher
Indian Medical Association
Abstract
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.
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Keywords
COVID-19 vaccine, AEFI, Safety, Covaxin,Sputnik V, Adverse effects, Side effects, India
Citation
Bhowmick Subhrojyoti, Maitra Subarnarekha, Paul Souvik, Ahmed Ahsan, Das Anupam, Kundu Tithishri, Das Nina, Ray Krishnangshu, Purkayastha Sujit Kar. An Observational Study Comparing the Adverse Effect Profiles of Sputnik V and Covaxin COVID-19 Vaccines in Adult General Population of Eastern India. Journal of The Indian Medical Association. 2022 Aug; 120(8): 40-44