SAFETY MONITORING OF COVID-19 VACCINE: IN A TERTIARY CARE HOSPITAL IN HARYANA
DOI:
https://doi.org/10.22159/ijpps.2023v15i3.47287Keywords:
Covid 19 vaccine, Adverse drug reactions, Vaccination, ChAdOx1 nCoV-19 vaccineAbstract
Objective: The present study aimed to ensure the safety and related potential adverse effects following ChAdOx1 nCoV-19 vaccination (AZD1222) in a scenario when numerous vaccines have been approved on an emergency basis by the WHO and other regulatory agencies to prevent the widespread of COVID-19 infection and to decrease the associated mortality and morbidity.
Methods: This study was an open, non-comparative, non-interventional, observational study conducted on healthcare workers of BPS Govt. medical college for women and elderly people who received the first dose of COVID-19 vaccinationChAdOx1 nCoV-19 vaccine (AZD1222) by conducting their interviews and recording the data
Results: Between January and March 2021, a total of 1907 participants were enrolled in this study. Out of 1907 recipients, 70 recipients reports adverse drug events following vaccination. Myalgia (0.629%), headache (1.31%), fever (≥ 37.5 °C, 0.839%) and fever with chills (≥ 37.5 °C, 1.048) were the most common adverse events after the first dose of vaccination of ChAdOx1 nCoV-19 vaccine (AZD1222. Throat irritation (0.209 %) and Generalised itching (0.262) were the least common adverse events.
Conclusion: ChAdOx1 nCoV-19 (Astrazeneca) has an acceptable safety profile as observed in this study. To our knowledge, very few studies are done that review the safety of COVID-19 vaccines. Further safety data from a larger sample size and of longer duration are warranted to establish safety
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References
World Health Organization. COVID-19 vaccines: safety surveillance manual; 2020. https://www.who.int/vaccine_safety/committee/Module_Regulatory_reliance.pdf. [Last accessed on 28 Jan 2021]
Narwat A, Rani S, Bhutani G, Saini R, Singh K. New coronavirus: is just a tip of iceberg? Int J Basic Clin Pharmacol. 2020;9(7):1147-52. doi: 10.18203/2319-2003.ijbcp20202957.
World Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. Available from: https://covid19.who.int/. [Last accessed on 28 Jan 2021]
RAPS CJ. COVID-19 vaccine tracker; 2021. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccinetracker. [Last accessed on 23 Jan 2021].
Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij Rammerstorfer S. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomized controlled trial. Lancet. 2020;396(10249):467-78. doi: 10.1016/S0140-6736(20)31604-4, PMID 32702298.
Fact sheet for vaccine recipient approved for restricted use in emergency situation of chadox1 ncov-19 coronavirus vaccine (recombinant). Available from: https://www,com.serum institute serum institute. [Last accessed on 19 Aug 2021]
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1, PMID 33306989.
Kaur RJ, Dutta S, Bhardwaj P, Charan J, Dhingra S, Mitra P. Adverse events reported from COVID-19 vaccine trials: a systematic review. Indian J Clin Biochem. 2021;36(4):427-39. doi: 10.1007/s12291-021-00968-z. PMID 33814753.
Yamamoto K. Adverse effects of COVID-19 vaccines and measures to prevent them. Virol J. 2022;19(1):100. doi: 10.1186/s12985-022-01831-0, PMID 35659687.
Beatty AL, Peyser ND, Butcher XE, Cocohoba JM, Lin F, Olgin JE. Analysis of COVID-19 vaccine type and adverse effects following vaccination. JAMA Netw Open. 2021; 4(12):e2140364. doi: 10.1001/jamanetworkopen.2021.40364. PMID 34935921.
Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID symptom study app in the UK: a prospective observational study. Lancet Infect Dis. 2021 Jul;21(7):939-49. doi: 10.1016/S1473-3099(21)00224-3, PMID 33930320.
Administration FaD: emergency use authorization for vaccines to prevent COVID-19: guidance for industry; 2020. https://www.fda.gov/media/142749/download. [Last accessed on 31 Jan 2021].
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Copyright (c) 2023 ARVIND NARWAT, MITALI DUA, ABHINAV GOYAL
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