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Published online: 2024-11-14

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Safety of Pfizer-BioNTech COVID-19 mRNA vaccine in the elderly

Artur Cieślewicz1, Katarzyna Korzeniowska1, Katarzyna Grabańska-Martyńska2, Anna Jabłecka1
DOI: 10.5603/mrj.101017

Abstract

Introduction. COVID-19 is an infectious viral disease that has affected more than 770 million people and has caused more than 6.9 million deaths worldwide. According to scientific data, the patient's age is the most important factor influencing the risk of severe disease course, including a substantially higher risk of death. Therefore, developing and distributing COVID-19 vaccines have become crucial in protecting this age group. Another thing typical for the elderly is that they usually suffer from many ailments, so polypharmacy is a common phenomenon among them. Objective. Our paper presents the initial results of the analysis of adverse effects in the group of older people in the context of participants' pharmacotherapy. Material and methods. The information concerning post-vaccination adverse effects, COVID-19 in the past, and current pharmacotherapy was collected via the analysis of medical documentation of 200 people aged 60 years or older. Statistical analysis was performed using StatSoft Statistica 13.1 software. Results. Twenty-three participants reported adverse effects after vaccination. Statistical analysis of groups with and without adverse effects revealed significant differences in age, cardiovascular drugs, neurological and psychiatric drugs, analgesics, gastrointestinal drugs, supplements, and vitamins. Conclusions. Obtained results suggest the need to study the potential effect of ongoing pharmacotherapy on the safety and effectiveness of vaccination.

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References

  1. COVID-19 epidemiological update – 17 June 2024. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20240617_covid-19_epi_update_168.pdf?. (11.07.2024).
  2. Soiza RL, Scicluna C, Thomson EC. Efficacy and safety of COVID-19 vaccines in older people. Age Ageing. 2021; 50(2): 279–283.
  3. Chen Y, Klein SL, Garibaldi BT, et al. Aging in COVID-19: Vulnerability, immunity and intervention. Ageing Res Rev. 2021; 65: 101205.
  4. Daoust JF. Elderly people and responses to COVID-19 in 27 Countries. PLoS One. 2020; 15(7): e0235590.
  5. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020; 395(10229): 1054–1062.
  6. Jordan RE, Adab P, Cheng KK. Covid-19: risk factors for severe disease and death. BMJ. 2020; 368: m1198.
  7. Underlying Medical Conditions Associated with High Risk for Severe COVID-19: Information for Healthcare Providers. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html#ref_1. (31.05.2024).
  8. Teo SP. Review of COVID-19 Vaccines and Their Evidence in Older Adults. Ann Geriatr Med Res. 2021; 25(1): 4–9.
  9. Chirico F, Teixeira da Silva JA, Tsigaris P, et al. Safety & effectiveness of COVID-19 vaccines: A narrative review. Indian J Med Res. 2022; 155(1): 91–104.
  10. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine. (31.05.2024).
  11. Whitaker HJ, Tsang RSM, Byford R, et al. Pfizer-BioNTech and Oxford AstraZeneca COVID-19 vaccine effectiveness and immune response amongst individuals in clinical risk groups. J Infect. 2022; 84(5): 675–683.
  12. Goronzy JJ, Weyand CM. Understanding immunosenescence to improve responses to vaccines. Nat Immunol. 2013; 14(5): 428–436.
  13. Li J, Hui A, Zhang X, et al. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nat Med. 2021; 27(6): 1062–1070.
  14. Thomas SJ, Moreira ED, Kitchin N, et al. C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021; 385(19): 1761–1773.
  15. Rahmani K, Shavaleh R, Forouhi M, et al. The effectiveness of COVID-19 vaccines in reducing the incidence, hospitalization, and mortality from COVID-19: A systematic review and meta-analysis. Front Public Health. 2022; 10: 873596.
  16. Monge S, Olmedo C, Alejos B, et al. COVID-19 Registries Study Group2. Direct and Indirect Effectiveness of mRNA Vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 in Long-Term Care Facilities, Spain. Emerg Infect Dis. 2021; 27(10): 2595–2603.
  17. Shrotri M, Krutikov M, Nacer-Laidi H, et al. Vaccine effectiveness of the first dose of ChAdOx1 nCoV-19 and BNT162b2 against SARS-CoV-2 infection in residents of long-term care facilities in England (VIVALDI): a prospective cohort study. Lancet Infect Dis. 2021; 21(11): 1529–1538.
  18. Coronavirus disease (COVID-19): Herd immunity, lockdowns and COVID-19. https://www.who.int/news-room/questions-and-answers/item/herd-immunity-lockdowns-and-covid-19. (31.05.2024).
  19. Li R, Bjørnstad ON, Stenseth NC. Prioritizing vaccination by age and social activity to advance societal health benefits in Norway: a modelling study. Lancet Reg Health Eur. 2021; 10: 100200.
  20. Liang CK, Lee WJ, Peng LN, et al. COVID-19 Vaccines in Older Adults: Challenges in Vaccine Development and Policy Making. Clin Geriatr Med. 2022; 38(3): 605–620.
  21. Comirnaty. Assessment report. Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency. 2021. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. (31.05.2024).
  22. FDA Approves First COVID-19 Vaccine. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. (31.05.2024).
  23. COVID-19 Vaccination Report. Polish Ministry of Health. . https://www.gov.pl/web/szczepimysie/raport-szczepien-przeciwko-covid-19. (31/05.2024).
  24. Ganesan S, Al Ketbi LM, Al Kaabi N, et al. Vaccine Side Effects Following COVID-19 Vaccination Among the Residents of the UAE-An Observational Study. Front Public Health. 2022; 10: 876336.
  25. Zhang L, Jiang L, Tian T, et al. Efficacy and Safety of COVID-19 Vaccination in Older Adults: A Systematic Review and Meta-Analysis. Vaccines (Basel). 2022; 11(1).
  26. Polack FP, Thomas SJ, Kitchin N, et al. C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020; 383(27): 2603–2615.
  27. Wu Q, Dudley MZ, Chen X, et al. Evaluation of the safety profile of COVID-19 vaccines: a rapid review. BMC Med. 2021; 19(1): 173.
  28. Crooke SN, Ovsyannikova IG, Poland GA, et al. Immunosenescence and human vaccine immune responses. Immun Ageing. 2019; 16: 25.
  29. Alfaddagh A, Martin SS, Leucker TM, et al. Inflammation and cardiovascular disease: From mechanisms to therapeutics. Am J Prev Cardiol. 2020; 4: 100130.
  30. Calcagno C, Fayad ZA. Clinical imaging of cardiovascular inflammation. Q J Nucl Med Mol Imaging. 2020; 64(1): 74–84.
  31. Furman D, Campisi J, Verdin E, et al. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019; 25(12): 1822–1832.
  32. Chen L, Deng H, Cui H, et al. Inflammatory responses and inflammation-associated diseases in organs. Oncotarget. 2018; 9(6): 7204–7218.
  33. Grolli RE, Mingoti ME, Bertollo AG, et al. Impact of COVID-19 in the Mental Health in Elderly: Psychological and Biological Updates. Mol Neurobiol. 2021; 58(5): 1905–1916.
  34. El-Ashmawy NE, Lashin AHA, Okasha KM, et al. The plausible mechanisms of tramadol for treatment of COVID-19. Med Hypotheses. 2021; 146: 110468.
  35. Awad K, Zaki MM, Mohammed M, et al. Lipid and Blood Pressure Meta-analysis Collaboration Group. Effect of the Renin-Angiotensin System Inhibitors on Inflammatory Markers: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Mayo Clin Proc. 2022; 97(10): 1808–1823.
  36. Kalra J, Chaturvedi A, Kalra S, et al. Modulation of pain perception by ramipril and losartan in human volunteers. Indian J Physiol Pharmacol. 2008; 52(1): 91–96.
  37. Liu W, Matsumori A. Calcium channel blockers and modulation of innate immunity. Curr Opin Infect Dis. 2011; 24(3): 254–258.
  38. Lee S, Jo S, Talbot S, et al. Novel charged sodium and calcium channel inhibitor active against neurogenic inflammation. Elife. 2019; 8.
  39. Dehnavi S, Sohrabi N, Sadeghi M, et al. Statins and autoimmunity: State-of-the-art. Pharmacol Ther. 2020; 214: 107614.
  40. Shahbaz SK, Sadeghi M, Koushki K, et al. Regulatory T cells: Possible mediators for the anti-inflammatory action of statins. Pharmacol Res. 2019; 149: 104469.
  41. Diamantis E, Kyriakos G, Quiles-Sanchez LV, et al. The Anti-Inflammatory Effects of Statins on Coronary Artery Disease: An Updated Review of the Literature. Curr Cardiol Rev. 2017; 13(3): 209–216.
  42. Bryniarski P, Nazimek K, Marcinkiewicz J. Immunomodulatory Potential of Diuretics. Biology (Basel). 2021; 10(12).
  43. Sakata N. The anti-inflammatory effect of metformin: The molecular targets. Genes Cells. 2024; 29(3): 183–191.
  44. Triggle CR, Mohammed I, Bshesh K, et al. Metformin: Is it a drug for all reasons and diseases? Metabolism. 2022; 133: 155223.
  45. Cameron AR, Morrison VL, Levin D, et al. Anti-Inflammatory Effects of Metformin Irrespective of Diabetes Status. Circ Res. 2016; 119(5): 652–665.
  46. Gałecki P, Mossakowska-Wójcik J, Talarowska M. The anti-inflammatory mechanism of antidepressants - SSRIs, SNRIs. Prog Neuropsychopharmacol Biol Psychiatry. 2018; 80(Pt C): 291–294.
  47. Kedika RR, Souza RF, Spechler SJ. Potential anti-inflammatory effects of proton pump inhibitors: a review and discussion of the clinical implications. Dig Dis Sci. 2009; 54(11): 2312–2317.
  48. Agarwal D, Schmader KE, Kossenkov AV, et al. Immune response to influenza vaccination in the elderly is altered by chronic medication use. Immun Ageing. 2018; 15: 19.
  49. Chakravarthy K, Strand N, Frosch A, et al. Recommendations and Guidance for Steroid Injection Therapy and COVID-19 Vaccine Administration from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2021; 14: 623–629.