Original Research Paper

COVISHIELD COVID VACCINE IN INDIA - DEMYSTIFYING MYTHS -SAFETY STUDY IN A TERTIARY CARE CENTRE OF SOUTHERN RAJASTHAN

  Abstract :

INTRODUCTION Nationwide COVID-19 vaccination was carried out in India in a phased manner from 16 Jan 2021 with COVISHIELD. This vaccine was indegeniously prepared by the Serum Institute of India in lines with the Oxford-AstraZeneca, ChAdOx1 (COVISHIELD) developed at Oxford. OBJECTIVE- This study was done to assess the safety of the indigenously prepared COVISHIELD vaccine in India. METHODS This study was carried out in tertiary care centre , RNT Medical college, southern rajasthan, India from jan,2021 to june 2021. People (n=500) who received the first dose of the COVISHIELD vaccine were followed up for seven days to check for any adverse effects or systemic effects post-vaccination. The data was collected by the supervisor with a participant administered questionnaire. The primary endpoint was the incidence of adverse or systemic effects at 7 days post-vaccination. Data were analyzed using SPSS v-23 software. RESULTS There were no serious adverse or systemic effects noted in 7 days follow up. Systemic symptoms were seen only in 240 (48%) individuals post-vaccination. Fever and bodyache was the most common effect of vaccination in 37.5 %(n=90) individuals followed by Myalgia and fatigue in 21.67 % (n=52) individuals. In most of the individuals the systemic symptoms started at 6-12 hours post-vaccination. There were no reports of fresh onset of systemic symptoms of any kind beyond 48 hours of vaccination. Females and adults tolerated the vaccination better with lesser systemic effects. CONCLUSION The absence of serious side effects makes the Serum Institute of Indias COVIDSHIELD vaccine safe for use. The lower systemic effects might indicate better tolerability of the vaccine in our study population and also translate to fewer lost man days due to vaccine related adverse effects.

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