Determination of Spectrum of Symptoms Observed Followed by Administration of 1st and 2nd Doses of COVISHIELD™ Vaccine in Datta Meghe Institute of Medical Sciences (Deemed to be University) – A Study Protocol

Abstract

Background: The 2019 novel coronavirus (2019-nCoV or SARS-CoV-2) was first detected in December 2019 in Wuhan City of Hubei, Province of China with population of 11 million, after outbreak of pneumonia. Present study deals with acceptability of newly manufactured vaccines against Covid 19 disease component of social misconceptions regarding the post vaccination symptoms and/or adverse events. Main rationale of this study is to list all post vaccination symptoms observed at multiple points of time to clear misconceptions resulting in possible increase in acceptability of newer vaccines. Aim: To determine the spectrum of symptoms observed followed by administration of 1st and 2nd doses of COVISHIELD™ vaccine in Datta Meghe Institute of Medical Sciences (deemed to be university). Methods: This will be a Prospective analytical cohort study conducted over a period of  5 years.  Procedure: Followed by letter of informed consent, pre validated questionnaire will be circulated amongst the healthcare professionals having been administered the 1st and 2nd doses of COVISHIELD™ vaccine filled and submitted to authorized email for further study and will be evaluated for enlisting post vaccination symptoms with time of onset and duration following 1st and 2nd doses of COVISHIELD™ vaccine. Follow up will maintained at regular intervals and questionnaire will be amongst participants at 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after the 2nd dose of COVISHIELD™ vaccine. Expected Outcome: Post vaccination symptoms following 1st and 2nd doses of COVISHIELD™ vaccine with range of time of onset and duration of the same will enhance status of the COVISHIELD™ vaccine awareness, social acceptability and willingness. Conclusion: All conclusions will be drawn after proper statistical analysis.