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Adverse events following ChAdOx1 nCoV-19 (Covisheild) vaccine administered in two-dose regimen: A single centre experience from Sri Lanka

Authors:

D. S. Govindapala ,

General Sir John Kotelawala Defence University, Rathmalana, LK
About D. S.
Department of Clinical Sciences, Faculty of Medicine
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R. M. U. S. Senarath,

General Sir John Kotelawala Defence University, Rathmalana, LK
About R. M. U. S.
Department of Clinical Sciences, Faculty of Medicine
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W. Wijenayake,

General Sir John Kotelawala Defence University, Rathmalana, LK
About W.
Department of Clinical Sciences, Faculty of Medicine
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T. D. Wijewardwna,

General Sir John Kotelawala Defence University, Rathmalana, LK
About T. D.
Department of Clinical Sciences, Faculty of Medicine
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W. M. I. D. Nakkawita,

General Sir John Kotelawala Defence University, Rathmalana, LK
About W. M. I. D.
Department of Paraclinical Sciences, Faculty of Medicine
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U. T. N. Senaratne,

General Sir John Kotelawala Defence University, Rathmalana, LK
About U. T. N.
Department of Multidisciplinary Sciences, Faculty of Allied Health Sciences
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P. Kawyangana,

General Sir John Kotelawala Defence University, Rathmalana, LK
About P.
Department of Paraclinical Sciences, Faculty of Medicine
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A. D. De Silva,

General Sir John Kotelawala Defence University, Rathmalana, LK
About A. D.
Department of Paraclinical Sciences, Faculty of Medicine
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N. S. Fernando

General Sir John Kotelawala Defence University, Rathmalana, LK
About N. S.
Department of Paraclinical Sciences, Faculty of Medicine
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Abstract

Introduction Phased distribution of the ChAdOx1nCoV-19 (Covisheild) vaccine was commenced in Sri Lanka in January 2021. Although the vaccine was well tolerated with a low reactogenicity profile in the clinical trials, there were safety concerns shortly after initiating vaccine rollouts in many countries. Objectives This prospective observational study aimed to profile the adverse events following immunization (AEFI) amongst recipients of the ChAdOx1nCoV-19 between 30th January to 5th February at the University Hospital, KDU. The associations of AEFI were also evaluated. Methods A cohort of 688 was followed up till the completion of vaccination. Data were collected using an interviewer-administered questionnaire and through telephone interviews. AEFI were classified according to WHO criteria. Results A total of 516(74.9%) participants experienced AEFI after the first dose, of which 377(73.0%) reported both systemic and local symptoms. By contrast, the incidence of AEFI were significantly lower after the second dose (n=134,21.1%, p<0.001). Fever being the commonest adverse event after the first dose (n=389,75.2%), injection site pain was frequent (n=85,63.43%) following the second dose. Of the four participants reported serious AEFI (0.6%) after the first dose, two had seizures. AEFI predominantly occurred within first 24 hours after each dose (77.1% and 67.9%, respectively) and lasted less than 72 hours in the majority (79.1% and 81.3%, respectively). The incidence of AEFI were significantly higher in females after the second dose (P=0.007). Conclusions The reactogenicity to the ChAdOx1nCoV-19 vaccine amongst our population was lower than expected in clinical trials. The absence of life-threatening adverse events indicates a good safety profile of the vaccine.
How to Cite: Govindapala, D.S., Senarath, R.M.U.S., Wijenayake, W., Wijewardwna, T.D., Nakkawita, W.M.I.D., Senaratne, U.T.N., Kawyangana, P., De Silva, A.D. and Fernando, N.S., 2022. Adverse events following ChAdOx1 nCoV-19 (Covisheild) vaccine administered in two-dose regimen: A single centre experience from Sri Lanka. Journal of the Ceylon College of Physicians, 53(1), pp.17–25. DOI: http://doi.org/10.4038/jccp.v53i1.7946
Published on 23 Jun 2022.
Peer Reviewed

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