Current Journal of Neurology

Current Issue

By Issue

By Author

By Subject

Author Index

Keyword Index

About Journal

Aims and Scope

Editorial Board

Publication Ethics

Indexing and Abstracting

Peer Review Process

Journal Metrics

News

Publication Ethics and Malpractice Statement

New diagnosis of multiple sclerosis in the setting of recent Sinopharm COVID-19 vaccine (BBIBP-CorV) exposure: A series of clinical cases and updated review of the literature

Articles in Press

Document Type : Original Article

Authors

1 Iranian Center of Neurological Research, Neuroscience Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran

2 Student Research Committee, School of Medicine, Qom University of Medical Sciences, Qom, Iran

Abstract

Background: Multiple sclerosis (MS) is the most common cause of non-traumatic disability in young individuals. There are limited reports of developing demyelinating events following the coronavirus disease 2019 (COVID-19) vaccination.
Methods: We reported all individuals (n = 8) with new MS diagnoses with recent exposure (≤ 6 weeks) to the Sinopharm (BBIBP-CorV) vaccine between September 2021 and June 2022. We also reviewed the related literature published as of September 2023.
Results: Of 338 newly diagnosed patients with MS who attended our tertiary referral MS center during the study period, 8 (2.36%) had their first demyelinating attack with a median interval of 2 [2.0, 4.0] weeks following the Sinopharm vaccine (sex ratio 1:1, median age: 20.5 [18.0, 27.0] years). 
No personal or family history of autoimmune/neurological disorders was documented, except for one patient's history of a previous potential demyelinating event and another's family history of immune thrombocytopenic purpura (ITP). All patients had demyelinating brain MRI lesions, and 4 had cervical spinal cord involvement. The brain areas most commonly affected were the periventricular and subcortical regions. Positive oligoclonal bands (OCBs) in all patients supported the MS diagnosis. All patients were diagnosed with relapsing-remitting MS and received intravenous methylprednisolone (IVMP) alone or in combination with plasma exchange (3/8). Rituximab was the most frequently used disease-modifying treatment (3/8).
Conclusion: This study provides preliminary evidence of a potential association between the Sinopharm vaccine and the initial manifestations of MS. However, further larger-scale studies with control groups and long-term follow-ups are needed to confirm this association and determine the underlying mechanisms.

Keywords

References
  1. Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol 2021; 19(3): 141-54.
  2. Cucinotta D, Vanelli M. WHO declares COVID-19 a pandemic. Acta Biomed 2020; 91(1): 157-60.
  3. World Health Organization. WHO Coronavirus (COVID-19) Dashboard [Online]. [cited 2022 Feb 28]; Available from: URL: https://covid19.who.int/
  4. Zali A, Khodadoost M, Gholamzadeh S, Janbazi S, Piri H, Taraghikhah N, et al. Mortality among hospitalized COVID-19 patients during surges of SARS-CoV-2 alpha (B.1.1.7) and delta (B.1.617.2) variants. Sci Rep 2022; 12(1): 18918.
  5. Jameie M, Safarian NM, Mansouri P, Jalali A, Aghajani F, Lotfi-Tokaldany M, et al. The impact of the COVID-19 pandemic on hospitalization rates due to prosthetic valve thrombosis. J Tehran Heart Cent 2023; 18(2): 136-41.
  6. Soheili A, Khani S, Montazeri S, Shayegh A, Miragha M, Jameie M, et al. COVID-19 and acute kidney injury presentation; stages and prognosis. J Prev Epidemiol 2021; 6(1): e15.
  7. Majidi F, Mohagheghi Dare RA, Jameie M, Jameie M, Mansouri P, Varpaei HA, et al. The relationship between cardiological parameters and PCR in patients with coronavirus infection: A cross-sectional study. Medicine (Baltimore) 2022; 101(50): e31935.
  8. Wang C, Tee M, Roy AE, Fardin MA, Srichokchatchawan W, Habib HA, et al. The impact of COVID-19 pandemic on physical and mental health of Asians: A study of seven middle-income countries in Asia. PLoS One 2021; 16(2): e0246824.
  9. Duden GS, Reiter J, Paswerg A, Weibelzahl S. Mental health of healthcare professionals during the ongoing COVID-19 pandemic: A comparative investigation from the first and second pandemic years. BMJ Open 2023; 13(3): e067244.
  10. Borhany H, Golbabaei S, Jameie M, Borhani K. Moral decision-making in healthcare and medical professions during the COVID-19 pandemic. Trends in Psychol 2023; 31(1): 210-30.
  11. Chen X, Laurent S, Onur OA, Kleineberg NN, Fink GR, Schweitzer F, et al. A systematic review of neurological symptoms and complications of COVID-19. J Neurol 2021; 268(2): 392-402.
  12. World Health Organization. Coronavirus Disease (COVID-19): Vaccines [Online]. [cited 2022 Mar 1]; Available from: URL: https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-(covid-19)-vaccines?gclid=CjwKCAiAgvKQBhBbEiwAaPQw3GLluFkuSSoT_AIhcXDldrPzXpnUkkciDrC70HeFHja3PHifQkQ5MxoCAoIQAvD_BwE&topicsurvey=v8kj13
  13. Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, et al. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler 2020; 26(14): 1816-21.
  14. Vandebergh M, Degryse N, Dubois B, Goris A. Environmental risk factors in multiple sclerosis: Bridging Mendelian randomization and observational studies. J Neurol 2022; 269(8): 4565-74.
  15. Abrahamyan S, Eberspacher B, Hoshi MM, Aly L, Luessi F, Groppa S, et al. Complete Epstein-Barr virus seropositivity in a large cohort of patients with early multiple sclerosis. J Neurol Neurosurg Psychiatry 2020; 91(7): 681-6.
  16. Najafi S, Ghane M, Poortahmasebi V, Jazayeri SM, Yousefzadeh-Chabok S. Prevalence of cytomegalovirus in patients with multiple sclerosis: A case-control study in northern Iran. Jundishapur J Microbiol 2016; 9(7): e36582.
  17. Rice EM, Thakolwiboon S, Avila M. Geographic heterogeneity in the association of varicella-zoster virus seropositivity and multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord 2021; 53: 103024.
  18. Kazmierski R, Wender M, Guzik P, Zielonka D. Association of influenza incidence with multiple sclerosis onset. Folia Neuropathol 2004; 42(1): 19-23.
  19. Khan F, Sharma P, Pandey S, Sharma D, Vijayavarman V, Kumar N, et al. COVID-19-associated Guillain-Barre syndrome: Postinfectious alone or neuroinvasive too? J Med Virol 2021; 93(10): 6045-9.
  20. Mahapure KS, Prabhune AS, Chouvhan AV. COVID-19-associated acute disseminated encephalomyelitis: A systematic review. Asian J Neurosurg 2021; 16(3): 457-69.
  21. Valiuddin H, Skwirsk B, Paz-Arabo P. Acute transverse myelitis associated with SARS-CoV-2: A case-report. Brain Behav Immun Health 2020; 5: 100091.
  22. Toljan K, Amin M, Kunchok A, Ontaneda D. New diagnosis of multiple sclerosis in the setting of mRNA COVID-19 vaccine exposure. J Neuroimmunol 2022; 362: 577785.
  23. Khayat-Khoei M, Bhattacharyya S, Katz J, Harrison D, Tauhid S, Bruso P, et al. COVID-19 mRNA vaccination leading to CNS inflammation: A case series. J Neurol 2022; 269(3): 1093-106.
  24. Havla J, Schultz Y, Zimmermann H, Hohlfeld R, Danek A, Kumpfel T. First manifestation of multiple sclerosis after immunization with the Pfizer-BioNTech COVID-19 vaccine. J Neurol 2022; 269(1): 55-8.
  25. Fujimori J, Miyazawa K, Nakashima I. Initial clinical manifestation of multiple sclerosis after immunization with the Pfizer-BioNTech COVID-19 vaccine. J Neuroimmunol 2021; 361: 577755.
  26. Goss AL, Samudralwar RD, Das RR, Nath A. ANA investigates: Neurological complications of COVID-19 vaccines. Ann Neurol 2021; 89(5): 856-7.
  27. Patone M, Handunnetthi L, Saatci D, Pan J, Katikireddi SV, Razvi S, et al. Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection. Nat Med 2021; 27(12): 2144-53.
  28. Ismail II, Salama S. A systematic review of cases of CNS demyelination following COVID-19 vaccination. J Neuroimmunol 2022; 362: 577765.
  29. Alroughani R, Al-Hashel J, Abokalawa F, AlMojel M, Farouk AS. COVID-19 vaccination in people with multiple sclerosis, real-life experience. Clin Neurol Neurosurg 2022; 220: 107374.
  30. Watad A, De Marco G, Mahajna H, Druyan A, Eltity M, Hijazi N, et al. Immune-mediated disease flares or new-onset disease in 27 subjects following mRNA/DNA SARS-CoV-2 vaccination. Vaccines (Basel) 2021; 9(5): 435.
  31. Farez MF, Correale J. Immunizations and risk of multiple sclerosis: Systematic review and meta-analysis. J Neurol 2011; 258(7): 1197-206.
  32. Langer-Gould A, Qian L, Tartof SY, Brara SM, Jacobsen SJ, Beaber BE, et al. Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. JAMA Neurol 2014; 71(12): 1506-13.
  33. Scheller NM, Svanstrom H, Pasternak B, Arnheim-Dahlstrom L, Sundstrom K, Fink K, et al. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA 2015; 313(1): 54-61.
  34. Mailand MT, Frederiksen JL. Vaccines and multiple sclerosis: A systematic review. J Neurol 2017; 264(6): 1035-50.
  35. Hapfelmeier A, Gasperi C, Donnachie E, Hemmer B. A large case-control study on vaccination as risk factor for multiple sclerosis. Neurology 2019; 93(9): e908-e916.
  36. Huttner A, Eperon G, Lascano AM, Roth S, Schwob JM, Siegrist CA, et al. Risk of MS relapse after yellow fever vaccination: A self-controlled case series. Neurol Neuroimmunol Neuroinflamm 2020; 7(4): e726.
  37. Jameie M, Togha M, Looha MA, Hemmati N, Jafari E, Nasergivehchi S, et al. Clinical characteristics and factors associated with headaches following COVID-19 vaccination: A cross-sectional cohort study (P14-12.003). Neurology 2023; 100 (17_Suppl_2): 4105.
  38. Garcia-Grimshaw M, Ceballos-Liceaga SE, Hernandez-Vanegas LE, Nunez I, Hernandez-Valdivia N, Carrillo-Garcia DA, et al. Neurologic adverse events among 704,003 first-dose recipients of the BNT162b2 mRNA COVID-19 vaccine in Mexico: A nationwide descriptive study. Clin Immunol 2021; 229: 108786.
  39. VAERS Team. Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (as of 29 January 2021) [Online]. [cited 2023 Sep 4]; Available from: URL: https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf
  40. Tagliaferri AR, Horani G, Stephens K, Michael P. A rare presentation of undiagnosed multiple sclerosis after the COVID-19 vaccine. J Community Hosp Intern Med Perspect 2021; 11(6): 772-5.
  41. Mathew T, John SK. COVID‐19 vaccine (ChAdOx1 nCoV‐19 Corona virus vaccine (Recombinant) – COVISHIELD related MS relapse. Neuroimmunology Reports 2021; 1: 100006.
  42. Kim KH, Kim SH, Park NY, Hyun JW, Kim HJ. Onset of various CNS inflammatory demyelination diseases following COVID-19 vaccinations. Mult Scler Relat Disord 2022; 68: 104141.
  43. Nistri R, Barbuti E, Rinaldi V, Tufano L, Pozzilli V, Ianniello A, et al. Case report: Multiple sclerosis relapses after vaccination against SARS-CoV2: A series of clinical cases. Front Neurol 2021; 12: 765954.
  44. Nabizadeh F, Ramezannezhad E, Kazemzadeh K, Khalili E, Ghaffary EM, Mirmosayyeb O. Multiple sclerosis relapse after COVID-19 vaccination: A case report-based systematic review. J Clin Neurosci 2022; 104: 118-25.
  45. Etemadifar M, Abhari AP, Nouri H, Sigari AA, Piran Daliyeh SM, Maracy MR, et al. Self-reported safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among Iranian people with multiple sclerosis. Hum Vaccin Immunother 2022; 18(1): 2041945.
  46. Ebrahimi N, Mazdak M, Shaygannejad V, Mirmosayyeb O. CNS demyelinating disease following inactivated or viral vector SARS-CoV-2 vaccines: A case series. Vaccine 2023; 41(5): 1003-8.
  47. Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. The CARE guidelines: Consensus-based clinical case reporting guideline development. J Med Case Rep 2013; 7: 223.
  48. World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013; 310(20): 2191-4.
  49. Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol 2018; 17(2): 162-73.
  50. Butler M, Tamborska A, Wood GK, Ellul M, Thomas RH, Galea I, et al. Considerations for causality assessment of neurological and neuropsychiatric complications of SARS-CoV-2 vaccines: From cerebral venous sinus thrombosis to functional neurological disorder. J Neurol Neurosurg Psychiatry 2021; 92(11): 1144-51.
  51. Ramo-Tello C, Blanco Y, Brieva L, Casanova B, Martinez-Caceres E, Ontaneda D, et al. Recommendations for the diagnosis and treatment of multiple sclerosis relapses. J Pers Med 2021; 12(1): 6.
  52. Mallapaty S. Iran hopes to defeat COVID with home-grown crop of vaccines. Nature 2021; 596(7873): 475.
  53. World Health Organization. The Sinopharm COVID-19 vaccine: What you need to know [Online]. [cited 2022 Mar 1]; Available from: URL: https://www.who.int/news-room/feature-stories/detail/the-sinopharm-covid-19-vaccine-what-you-need-to-know
  54. World Health Organization. Annexes to the interim recommendations for use of the inactivated COVID-19 vaccine BIBP developed by China National Biotec Group (CNBG), Sinopharm, 7 May 2021 [Online]. [cited 2021 May 7]; Available from: URL: https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-BIBP-annexes-2021.1
  55. Pormohammad A, Zarei M, Ghorbani S, Mohammadi M, Razizadeh MH, Turner DL, et al. Efficacy and safety of COVID-19 vaccines: A systematic review and meta-analysis of randomized clinical trials. Vaccines (Basel) 2021; 9(5): 467.
  56. Gee J, Marquez P, Su J, Calvert GM, Liu R, Myers T, et al. First month of COVID-19 vaccine safety monitoring - United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep 2021; 70(8): 283-8.
  57. 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 randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021; 397(10269): 99-111.
  58. Centers for Disease Control and Prevention. People with Certain Medical Conditions [Online]. [cited 2022 Feb 28]; Available from: URL: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Frecommendations%2Funderlying-conditions.html
  59. Jameie M, Togha M, Azizmohammad LM, Jafari E, Yazdan PM, Hemmati N, et al. Characteristics of headaches attributed to SARS-CoV-2 vaccination and factors associated with its frequency and prolongation: A cross-sectional cohort study. Front Neurol 2023; 14: 1214501.
  60. Abara WE, Gee J, Marquez P, Woo J, Myers TR, DeSantis A, et al. Reports of Guillain-Barre syndrome after COVID-19 vaccination in the United States. JAMA Netw Open 2023; 6(2): e2253845.
  61. Rafati A, Pasebani Y, Jameie M, Yang Y, Jameie M, Ilkhani S, et al. Association of SARS-CoV-2 vaccination or infection with bell palsy: A systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg 2023; 149(6): 493-504.
  62. Eslait-Olaciregui S, Llinas-Caballero K, Patino-Manjarres D, Urbina-Ariza T, Cediel-Becerra JF, Dominguez-Dominguez CA. Serious neurological adverse events following immunization against SARS-CoV-2: A narrative review of the literature. Ther Adv Drug Saf 2023; 14: 20420986231165674.
  63. Mirmosayyeb O, Ghaffary EM, Vaheb S, Pourkazemi R, Shaygannejad V. Multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) following COVID-19 vaccines: A systematic review. Rev Neurol (Paris) 2023; 179(4): 265-81.
  64. Amanollahi M, Jameie M, Heidari A, Rezaei N. The dialogue between neuroinflammation and adult neurogenesis: Mechanisms involved and alterations in neurological diseases. Mol Neurobiol 2023; 60(2): 923-59.
  65. Amanollahi M, Jameie M, Rezaei N. Neuroinflammation as a potential therapeutic target in neuroimmunological diseases. In: Rezaei N, Yazdanpanah N, editors. Translational Neuroimmunology, Volume 7. 1st Cambridge, MA: Academic Press; 2023. p. 475-504.
  66. Salemi S, D'Amelio R. Could autoimmunity be induced by vaccination? Int Rev Immunol 2010; 29(3): 247-69.
  67. Wraith DC, Goldman M, Lambert PH. Vaccination and autoimmune disease: What is the evidence? Lancet 2003; 362(9396): 1659-66.
  68. Garcia-Grimshaw M, Ceballos-Liceaga SE, Hernandez-Vanegas LE, Nunez I, Hernandez-Valdivia N, Carrillo-Garcia DA, et al. Systemic and neurologic adverse events among 704,003 first-dose recipients of the Pfizer-Biontech (BNT162b2) mRNA COVID-19 vaccine in Mexico [Online]. [cited 2021]; Available from: URL: https://ssrn.com/abstract=3816489 or http://dx.doi.org/10.2139/ssrn.3816489
  69. World Health Organization. Causality assessment of an adverse event following immunization (AEFI): User manual for the revised WHO classification. Geneva, Switzerland: WHO; 2018.
  70. Shimonovich M, Pearce A, Thomson H, Keyes K, Katikireddi SV. Assessing causality in epidemiology: Revisiting Bradford Hill to incorporate developments in causal thinking. Eur J Epidemiol 2021; 36(9): 873-87.
Current Journal of Neurology

Articles in Press, Accepted Manuscript
Available Online from 08 January 2024
Files
Share
How to cite
Statistics