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VOLUME 5 , ISSUE 1 ( January-June, 2021 ) > List of Articles

ORIGINAL RESEARCH ARTICLE

A Study of COVID-19 Vaccine (COVISHIELD) Pharmacovigilance in Primary Healthcare Workers in Punjab, India

Rahat Kumar, Jaswinder Singh, Narinder Singh, Vikram Bhandari

Keywords : Coronavirus, Covishield, Pharmacovigilance, SARS-CoV-2

Citation Information : Kumar R, Singh J, Singh N, Bhandari V. A Study of COVID-19 Vaccine (COVISHIELD) Pharmacovigilance in Primary Healthcare Workers in Punjab, India. Curr Trends Diagn Treat 2021; 5 (1):6-11.

DOI: 10.5005/jp-journals-10055-0111

License: CC BY-NC 4.0

Published Online: 00-06-2021

Copyright Statement:  Copyright © 2021; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Aims and Objectives: Coronavirus disease-2019 (COVID-19) is caused by a novel RNA coronavirus that can cause lethal diseases, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome. Symptom onset is from 3 to 5 days with mild- to high-grade fever, persistent cough, mild to severe dyspnea with fall in SpO2, anosmia, ageusia, and fatigue. The management of COVID-19 infection includes oxygen, antiviral drugs like lopinavir or ritonavir, remdesivir, oseltamivir, favipiravir, ventilatory support, antibiotics, etc. Unfortunately, 100% recovery rate is not seen, and many patients die due to complications, so the main emphasis is on vaccine administration for the induction of virus-neutralizing antibodies. This study was done to assess the safety of Covishield in primary healthcare workers so as to assess the risk assessment in general population. Materials and methods: Covishield (ChAdOx1 nCoV-19), a coronavirus vaccine (recombinant), is manufactured by the Serum Institute of India Pvt. Ltd. Pune, India. Covishield has been approved for emergency authorization against COVID-19 infection. Covishield during phase I vaccination drive after consent was given to the 1,054 healthcare workers of Sri Guru Ram Das Institute of Medical Sciences and Research (SGRDIMSAR), Amritsar, and safety data were generated in postvaccination phase. Results: It was observed that there were 97.3% of solicited reactions and 2.7% of unsolicited reactions. Most of the solicited reactions were pain at the injection site, mild fever, malaise, and headache with a duration of symptoms generally for 2–3 days. In the unsolicited reactions, mainly moderate- to high-grade fever followed by decreased appetite and dizziness with a duration of 2–3 days were observed. Only in one subject, an increase in liver function test occurred for 3 days. Conclusion: The findings of our study indicate that Covishield vaccine has provided excellent tolerability in health care subjects who willingly received the vaccine during phase I mass vaccination, and there was no report of any untoward side effects demanding attention in such patients. Clinical significance: The tolerability of Covishield vaccine observed in the present study can be used to extrapolate the safety in the general population. Thus, mass vaccination with Covishield is recommended in the general population without any fear of vaccine-related serious side effects.


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