Adverse events following immunization associated with the ChAdOx1nCoV-19 and BBV152 vaccine - a cross-sectional study

Pharmaceutical Science-Pharmacy practice

Authors

  • Dr. Durga Prasad T. S Associate Professor, Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tirupati, Andhra Pradesh India, PIN-517503. https://orcid.org/0000-0002-3867-5033
  • Guna Gouru Pharm D Interns, Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tirupati, Andhra Pradesh India, PIN-517503.
  • S. Vasuprada Pharm D Interns, Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tirupati, Andhra Pradesh India, PIN-517503.
  • B. Sandhya Pharm D Interns, Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tirupati, Andhra Pradesh India, PIN-517503.
  • Kavi Priya D.S. Pharm D Interns, Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tirupati, Andhra Pradesh India, PIN-517503.
  • T. Sudhakar Pharm D Interns, Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tirupati, Andhra Pradesh India, PIN-517503.

DOI:

https://doi.org/10.22376/ijlpr.2023.13.3.P76-P83

Keywords:

Corona Virus Disease-2019 (COVID-19), Adverse events following immunization (AEFI), ChAdOx1nCoV-19 (Covishield), BBV152 (Covaxin).

Abstract

COVID-19, an infectious disease, has become a leading cause of death in many people. The rapid emergence of the pandemic prompted the development of a vaccine to mitigate the disease's harmful consequences. Vaccination is the only effective way to prevent infection from spreading and build immunity to the virus. However, developing adverse effects has become a major problem for vaccine reluctance. Accordingly, the interest has been shifted towards identifying the adverse effects developed following immunization. The current study objective is to assess and compare the intensity of adverse effects following 1st and 2nd dose of COVID-19 vaccination and the medication administered to relieve the symptoms associated with vaccination. A cross-sectional study was performed in a community over six months. A total of 836 participants were involved in the study. All the data regarding the vaccination were collected through a specially designed questionnaire form and analyzed in all the participants within the study group. According to the study, at least 1 AEFI was developed in about 90% of the study population. The most common systemic and local effect developed in the study population was fever (59.42%) and pain at the injection site (69.82%), respectively. With both vaccines (ChAdOx1 nCoV-19 and BBV152), the incidence and severity of AEFIs were lower after the second dose than after the first dose, and most of the symptoms associated with vaccination were alleviated by taking home remedies and symptomatic treatment. The adverse effects reported after receiving the ChAdOx1 nCoV-19 and BBV152 vaccines are typical of most vaccines, and the majority of them were tolerated, and most subsided in less than 24 hours. 

References

Parasher A.A. COVID-19. COVID-19: Current understanding of its pathophysiology, clinical presentation, and treatment. Postgrad Med J. 2021;97(1147):312-20. doi: 10.1136/postgradmedj-2020-138577, PMID 32978337.

Bian J, Li Z. Angiotensin-converting enzyme 2 (ACE2): SARS-CoV-2 receptor and RAS modulator. Acta Pharm Sin B. 2021;11(1):1-12. doi: 10.1016/j.apsb.2020.10.006. PMID 33072500.

Simnani FZ, Singh D, Kaur R. COVID-19 phase 4 vaccine candidates, effectiveness on SARS-CoV-2 variants, neutralizing antibody, rare side effects, traditional and nano-based vaccine platforms: a review. 3 Biotech. 2022;12(1):15. doi: 10.1007/s13205-021-03076-0, PMID 34926119.

Lebeau G, Vagner D, Frumence É, Ah-Pine F, Guillot X, Nobécourt E, et al. Deciphering SARS-CoV-2 virologic and immunologic features. Int J Mol Sci. 2020;21(16):5932. doi: 10.3390/ijms21165932, PMID 32824753.

Beyerstedt S, Casaro EB, Rangel ÉB. COVID-19: angiotensin-converting enzyme 2 (ACE2) expression and tissue susceptibility to SARS-CoV-2 infection. Eur J Clin Microbiol Infect Dis. 2021 May;40(5):905-19. doi: 10.1007/s10096-020-04138-6, PMID 33389262.

Francis AI, Ghany S, Gilkes T, Umakanthan S. Review of COVID-19 vaccine subtypes, efficacy, and geographical distributions. Postgrad Med J. 2022 May;98(1159):389-94 [Epub] 2021 Aug6. doi: 10.1136/postgradmedj-2021-140654, PMID 34362856.

Dutta S, Kaur RJ, Bhardwaj P, Sharma P, Ambwani S, Islam S, et al. Adverse events reported from the COVID-19 vaccines: A descriptive study based on the WHO database (VigiBase®). J Appl Pharm Sci. 2021;11(08):001-9.

Chaudhary S, El-Shorbagi A, Gupta RK, Kumar A. The recent updates on approaches and clinical trials status of Covid-19 vaccines developed globally. Biomed Pharmacol J. 2021;14(3):1109-24. doi: 10.13005/bpj/2214.

Ministry of Science and Technology. DBT‐BIRAC supported ZyCoVD developed by ZydusCadila Receives Emergency Use Authorization. Press Information Bureau [cited Sep 20, 2201]. Available from: https://pib.gov.in/PressReleasePage.aspx?PRID=1747669.

Press Information Bureau. PIB’s bulletin on COVID‐19. PIB Headquarters [cited Sep 20, 2021]. Available from: https://pib.gov.in/PressReleasePage.aspx?PRID=1743567.

Ministry of Health and Family Welfare. The national regulator grants permission for restricted use in emergencies Sputnik‐V vaccine. Press Information Bureau [cited Sep 20, 2021]. Available from: https://pib.gov.in/PressReleasePage.aspx?PRID=1711342.

Mahapatra S, Nagpal R, Marya CM, Taneja P, Kataria S. Adverse events occurring post-Covid-19 vaccination among healthcare professionals – A mixed method study. Int Immunopharmacol. 2021; 100:108136. doi: 10.1016/j.intimp.2021.108136, PMID 34587578.

Jeon M, Kim J, Oh CE, Lee JY. Adverse Events following Immunization Associated with the First and second Doses of the ChAdOx1 nCoV-19 Vaccine among Healthcare Workers in Korea. 2021;9(10):1096. doi: 10.3390/vaccines9101096, PMID 34696204.

Salibi N, Abdulrahim S, El Haddad M, Bassil S, El Khoury Z, Ghattas H, et al. COVID-19 vaccine acceptance in older Syrian refugees: preliminary findings from an ongoing study. Prev Med Rep. 2021 December; 24:101606. doi: 10.1016/j.pmedr.2021.101606, PMID 34692378, PMCID PMC8523309.

Aw J, Seng JJB, Seah SSY, Low LL. COVID-19 Vaccine Hesitancy-A Scoping Review of Literature in High-Income Countries. Vaccines. 2021;9(8):900. doi: 10.3390/vaccines9080900, PMID 34452026.

Ossato A, Tessari R, Trabucchi C, Zuppini T, Realdon N, Marchesini F. Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. Eur J Hosp Pharm. 2021;0:1-6. doi: 10.1136/ejhpharm-2021-002933, PMID 34315774.

Parida SP, Sahu DP, Singh AK, Alekhya G, Subba SH, Mishra A, et al. Adverse events following COVID‐19 (Covaxin) vaccine immunization at a tertiary care center of India. J Med Virol. 2022;94(6):2453-9. doi: 10.1002/jmv.27655, PMID 35149993.

Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized 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.

Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): A single-blind, randomized, controlled, phase 2/3 trial. Lancet. 2021;396(10267):1979-93. doi: 10.1016/S0140-6736(20)32466-1, PMID 33220855.

Astra Zeneca's COVID-19 vaccine: EMA finds it possible to link to rare cases of unusual blood clots with low blood platelets; 2021 [cited Jun 20, 2021]. Available from: https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood.

Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, et al. 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;21(7):939-49. doi: 10.1016/S1473-3099(21)00224-3, PMID 33930320.

Kaur RJ, Dutta S, Bhardwaj P, Charan J, Dhingra S, Mitra P et al. A systematic review of adverse events reported from COVID-19 vaccine trials. Indian J Clin Biochem. 2021 October;36(4):427-39. doi: 10.1007/s12291-021-00968-z, PMID 33814753, PMCID PMC7997788.

Beatty AL, Peyser ND, Butcher XE, Cocohoba JM, Lin F, Olgin JE, et al. Analysis of COVID-19 vaccine type and adverse effects following vaccination. JAMA Netw Open. 2021 December 1;4(12):e2140364. doi: 10.1001/jamanetworkopen.2021.40364, PMID 34935921, PMCID PMC8696570.

Norwegian Medicines Agency. Reported suspected adverse reactions to COVID-19 vaccines as of 14.12.2021; 2021. Available from: https://legemiddelverket.no/Documents/English/Covid-19/20211217%20Reported%20suspected%20adverse%20reactions%20coronavirus%20vaccines.pdf.

Riad. A Pokorna. A, Mekhemar.M, Conrad. J, Klugarova. J, Kos cik. M, Klugar. M, Attia. S. Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States. Vaccines 2021; 9: 673. https://www.mdpi.com/2076-393X/9/6/673.

Published

2023-05-01

How to Cite

Prasad T. S, D. D. ., Gouru, G. ., Vasuprada, S. ., Sandhya, B. ., Priya D.S., K. ., & Sudhakar, T. . (2023). Adverse events following immunization associated with the ChAdOx1nCoV-19 and BBV152 vaccine - a cross-sectional study: Pharmaceutical Science-Pharmacy practice. International Journal of Life Science and Pharma Research, 13(3), P76-P83. https://doi.org/10.22376/ijlpr.2023.13.3.P76-P83

Issue

Section

Research Articles