ADVERSE EVENTS FOLLOWING VACCINATION WITH A VIRAL VECTOR-BASED VACCINE - A CROSS-SECTIONAL STUDY
DOI:
https://doi.org/10.58395/dvaah470Keywords:
viral vector-based vaccines, COVID-19, adverse events, safetyAbstract
Background: The effectiveness and safety of recently implemented COVID-19 vaccine platforms are often compared since the launch of the mass vaccination campaign worldwide. The aim of the present study is to assess the prevalence of adverse events (AEs) occurring after vaccination with the two viral vector-based vaccines authorized in the European Union to prevent COVID-19.
Materials and methods: A survey was carried out among adults who have completed vaccination with either of the viral vector-based vaccine approved for use in Bulgaria ChAdOx1-S nCoV-19 vaccine (commonly known as Astra Zeneca or Vaxzevria) or Ad26.COV2S vaccine (commonly known as Janssen or JCOVDEN). For the data analysis, standard descriptive statistics was used. Quantitative variables are presented by the mean and standard deviation (mean ± SD) or median (25th percentile; 75th percentile). Qualitative variables are presented as numbers absolute/relative frequencies totals and percentages. The Kolmogorov-Smirnov test was used to obtain information regarding the distribution of the sampled patients. The chi-square test for independence was used to determine whether differences between observed and theoretical distributions existed.
Results: In total 314 respondents took part in the study. Of them, 273 (86.9%) reported at least one local AE after the first dose of a vaccine, and the prevalence among the ChAdOx1-S vaccine group was significantly higher (88.5%) than in the Ad26.COV2.S vaccine group (59.2%) (Pearson χ2 test=19.942, p=0.000). The most common systemic AEs after administration of a viral vector-based vaccine were chills (77.3% for ChAdOx1-S and 25.9% for Ad26. COV2.S.) fatigue (76.3% for ChAdOx1-S and 25.9% for Ad26.COV2.S.), and headache (62.3% for ChAdOx1-S and 25.9% for Ad26.COV2.S.). Those adverse events appeared significantly more often in participants vaccinated with the ChAdOx1-S vaccine.
Conclusion: The analysis of the collected data proves that although common, AEs following vaccination with vector-based products are classified as mild and usually resolve within 48 hours of dose administration.
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References
Dal-Ré R. The winding 12-month journey of the AstraZeneca COVID-19 vaccine since its first administration to humans. Therapie. 2022 Jul 13:S0040-5957(22)00120-2.
Michael Bang Petersen, Frederik Jørgensen, Marie Fly Lindholt, “Did the European suspension of the AstraZeneca vaccine decrease vaccine acceptance during the COVID-19 pandemic?”, Vaccine, 2022; 40(4):558-561. https://doi.org/10.1016/j.vaccine.2021.12.026
Xianyu (Bonnie) Hao, Mayank Anand, TzuShuo (Ryan) Wang, Akshay R. Rao, “Reducing COVID vaccine hesitancy by inducing a comparative mindset”, Vaccine, 2022, 40(52): 7547-7558, https://doi.org/10.1016/j.vaccine.2022.10.077
ECDC, Data on COVID-19 vaccination in the EU/EEA, available at: https://www.ecdc.europa.eu/en/publications-data/datacovid-19-vaccination-eu-eea, [Last accessed: 7 February 2023].
European medicine agency (EMA) An overview of Vaxzevria and why it is authorized in the EU https://www.ema.europa.eu/en/documents/overview/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-medicine-overview_en.pdf [Last accessed February 10, 2023].
European medicine agency (EMA) JCOVDEN Summary of product characteristics. https://www.ema.europa.eu/en/documents/product-information/jcovden-previously-covid-19-vaccine-janssen-epar-product-information_en.pdf [Last accessed February 10, 2023].
Yan, Y., Pang, Y., Lyu, Z. et al. The COVID-19 Vaccines: Recent Development, Challenges and Prospects. Vaccines (Basel) 2021, 9, 349. https://doi.org/10.3390/vaccines9040349
Nohl, A., Brune, B., Weichert, V. Standl, F., Stang, A., Dudda, M. “COVID-19: Vaccination Side Effects and Sick Leave in Frontline Healthcare-Workers—A Web-Based Survey in Germany”. Vaccines (Basel) 2022, 10, 411. https://doi.org/10.3390/vaccines10030411
Benjamanukul S, Traiyan S, Yorsaeng R, et al. Safety and immunogenicity of inactivated COVID-19 vaccine in health care workers. J Med Virol. 2022;94:1442-1449. https://doi.org/10.1002/jmv.27458
Bae S, Lee YW, Lim SY, et al. Adverse Reactions Following the First Dose of ChAdOx1 nCoV-19 Vaccine and BNT162b2 Vaccine for Healthcare Workers in South Korea. J Korean Med Sci. 2021; 36(17):e115. https://doi.org/10.3346/jkms.2021.36.e115. PMID: 33942579.
Rangelova V, Raycheva R, Sariyan S, Kevorkyan A (2022) Reporting adverse events of COVID-19 vaccines: The case of Bulgaria. PLoS ONE 17(6): e0269727. https://doi.org/10.1371/journal.pone.0269727
Sa, S., Lee, C.W., Shim, S.R. et al. “The Safety of mRNA- 1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data. Vaccines 2022, 10, 320. https://doi.org/10.3390/vaccines10020320
Bhandari, B., Rayamajhi, G., Lamichhane, P., & Shenoy, A. K. (2022). Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. BioMed research international, 2022, 2911333. https://doi.org/10.1155/2022/2911333
Jęśkowiak I, Wiatrak B, Grosman-Dziewiszek P, Szeląg A. The Incidence and Severity of Post-Vaccination Reactions after Vaccination against COVID-19. Vaccines (Basel). 2021 May 13;9(5):502. https://doi.org/10.3390/vaccines9050502
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 accine (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. https://doi.org/10.1016/S0140-6736(20)32661-1
European Medicines Agency. Assessment report COVID-19 vaccine AstraZeneca. https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf. Updated 2021. [Last accessed February 6, 2023].
Centres for Disease Control and Prevention, The Janssen COVID-19 Vaccine’s Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/reactogenicity.html [Last accessed February 13 2023].
Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine. Janssen. https://www.janssen.com/johnson-johnson-single-shotcovid-19-vaccine-phase-3-data-published-new-englandjournal-medicine. Published April 21, 2021. [ Last accessed February 6, 2023].
Janssen COVID-19 Emergency Use Authorization (EUA) Official Website. Janssen COVID-19 Vaccine Official Website. https://www.janssencovid19vaccine.com/ [Last accessed February 6, 2023].
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. Vaccines (Basel). 2021 Sep 28;9(10):1096. https://doi.org/10.3390/vaccines9101096
Riad A, Pokorná A, Attia S, Klugarová J, Koščík M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. https://doi.org/10.3390/jcm10071428
Alghamdi, A.; Ibrahim, A.; Almutairi, R.; Joseph, M.; Alghamdi, G.; Alhamza, A. A cross-sectional survey of side effects after COVID-19 vaccination in Saudi Arabia: Male versus female outcomes. J. Adv. Pharm. Educ. Res. 2021, 11, 51–56. https://doi.org/10.51847/bCwca2qGfP
Klein, S.L.; Jedlicka, A.; Pekosz, A. The Xs and Y of immune responses to viral vaccines. Lancet Infect. Dis. 2010, 10, 338–349.; https://doi.org/10.1016/S1473-3099(10)70049-9
Bartley, E.J.; Fillingim, R.B. Sex differences in pain: A brief review of clinical and experimental findings. BJA Br. J. Anaesth. 2013, 111, 52. https://doi.org/10.1093/bja/aet127
Menni, C.; Klaser, K.; May, A.; Polidori, L.; Capdevila, J.; Louca, P.; Sudre, C.H.; Nguyen, L.H.; Drew, D.A.; Merino, J.; 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, 939–949. https://doi.org/10.1016/S1473-3099(21)00224-3
Sprent, J.; King, C. COVID-19 vaccine side effects: The positives about feeling bad. Sci. Immunol. 2021, 6, eabj9256. https://doi.org/10.1126/sciimmunol.abj9256
Bunders, M.J.; Altfeld, M. Implications of Sex Differences in Immunity for SARS-CoV-2 Pathogenesis and Design of Therapeutic Interventions. Immunity 2020, 53, 487–495. https://doi.org/10.1016/j.immuni.2020.08.003
Beg BM, Hussain T, Ahmad M, et al.: Perceived risk and perceptions of COVID-19 vaccine: a survey among general public in Pakistan. PLoS One. 2022, 17: https://doi.org/10.1371/journal.pone.0266028
Ebinger JE, Fert-Bober J, Printsev I, et al. Antibody responses to the BNT162b2 mRNA vaccine in individuals previously infected with SARS-CoV-2. Nature Med 2021; 27:981–4. https://doi.org/10.1038/s41591-021-01325-6
Tré-Hardy M, Cupaiolo R, Papleux E, et al. Reactogenicity, safety and antibody response, after one and two doses of mRNA-1273 in seronegative and seropositive healthcare workers. J Infect 2021; 83:237–79. https://doi.org/10.1016/j.jinf.2021.03.025
Raw RK, Rees J, Kelly CA, Wroe C, Chadwick DR. Prior COVID-19 infection is associated with increased adverse events (AEs) after the first, but not the second, dose of the BNT162b2/Pfizer vaccine. Vaccine 2022; 40:418–23. https://doi.org/10.1016/j.vaccine.2021.11.090
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Copyright (c) 2023 Vanya Rangelova, Zhivka Getsova (Author)
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