COVID-19 Vaccine Linked to Rare Neurological Disorder: Transverse Myelitis

Strategic Insights -

Research from the University Teaching Hospital in Caen, France, has found a significant association between certain COVID-19 vaccines and the rare neurological disorder, transverse myelitis (TM). The study, which analyzed data from the World Health Organization's pharmacovigilance database, VigiBase, found that mRNA-based and vector-based SARS-CoV-2 vaccines authorized by the FDA or the EMA were associated with TM. However, the study's authors emphasize that the risk-benefit ratio in favor of vaccination against SARS-CoV-2 virus remains unchallenged, and the occurrence of TM remains a rare event.

Key Takeaways:

  • The study found a significant association between TM and mRNA-based SARS-CoV-2 vaccines (n = 364; IC = 0.62) and vector-based SARS-CoV-2 vaccines (n = 136; IC = 0.52) authorized by the FDA or the EMA.
  • The risk-benefit ratio in favor of vaccination against SARS-CoV-2 virus remains unchallenged, and the occurrence of TM remains a rare event, with a previously reported rate of 0.28 cases per 1 million vaccine doses.
  • The study's authors suggest that clinicians should consider the diagnosis of TM in patients presenting with early signs of spinal cord dysfunction after SARS-CoV-2 vaccination.
  • The research was conducted using data from VigiBase, the World Health Organization's pharmacovigilance database, from December 1, 2020, to March 27, 2022.
  • The study's findings have been peer-reviewed and published in the Annals of Neurology journal.

Statistics:

  • The study analyzed 364 cases of TM associated with mRNA-based SARS-CoV-2 vaccines (IC = 0.62) and 136 cases associated with vector-based SARS-CoV-2 vaccines (IC = 0.52).
  • The previously reported rate of TM cases per 1 million vaccine doses was 0.28.
  • The study found that mRNA-based and vector-based SARS-CoV-2 vaccines authorized by the FDA or the EMA were associated with TM.

Sources:

  • University Teaching Hospital, Caen, France
  • Annals of Neurology, Wiley, 111 River St, Hoboken 07030-5774, NJ, USA
  • Etienne Bastien, Dept. of Pharmacology, University Teaching Hospital of Caen-Normandie, Caen, France
  • Sophie Nguyen, Basile Chretien, Marion Sassier, Gilles Defer, Ahmad Nehme, Veronique Lelong-Boulouard, Joachim Alexandre, Sophie Fedrizzi, and Pierre-Marie Morice
  • VigiBase, the World Health Organization's pharmacovigilance database