mRNA COVID-19 Vaccination Safety Profiles Identified in WHO's Global Database

Strategic Insights -

Researchers at Chung-Ang University in South Korea have conducted a study on the adverse events following mRNA COVID-19 vaccination, using the World Health Organization's global scale database, VigiBase. The study aimed to identify patterns associated with serious adverse event reports after mRNA COVID-19 vaccination. Funded by the Government-wide R&D Fund project for infectious disease research, the study analyzed reports from December 28, 2020, to February 28, 2022, and identified five clusters of serious adverse event reports: infection, cardiac, respiratory/thrombotic, systemic, and nervous system.

Key Takeaways:

  • The study used a latent class analysis (LCA) of reports of serious adverse events (AEs) following mRNA COVID-19 vaccination from VigiBase between December 28, 2020, and February 28, 2022.
  • Five clusters of AE reports were distinguished through LCA: infection AEs (cluster 1), cardiac AEs (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), and nervous system AEs (cluster 5).
  • Cluster 2 had a higher proportion of males compared to cluster 4 (OR 2.98; 95% CI 2.87-3.09).
  • Cluster 1 had a longer time to onset than other AEs (14 days) (OR 16.2; 95% CI 15.5-16.9).
  • The study suggested that monitoring should carefully consider the patterns of young males with cardiac AEs and elderly individuals with thrombosis after respiratory AEs.

Statistics:

  • 312,878 reports of serious AEs following mRNA COVID-19 vaccination were analyzed from VigiBase.
  • The study identified five clusters of serious AEs within this dataset.
  • The proportion of males in cluster 2 was found to be 2.98 times higher than in cluster 4 (OR 2.98; 95% CI 2.87-3.09).
  • The time to onset of AEs in cluster 1 was found to be significantly longer than other AEs (14 days) (OR 16.2; 95% CI 15.5-16.9).

Sources:

  • NewsRx. Chung-Ang University Reports Findings in COVID-19 [Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis]. Information Technology Newsweekly. December 27, 2022; p 6.
  • Infectious Diseases and Therapy. Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis. Infectious Diseases and Therapy, 2022.