COVID-19 Vaccine Safety Study Reveals Insights into Severe Adverse Events

Strategic Insights -

Researchers from the University of Pennsylvania compared the safety of different COVID-19 vaccines, including those from Pfizer, Moderna, and Janssen, using both randomized controlled trials (RCTs) and the Vaccine Adverse Event Reporting System (VAERS) data. The study aimed to identify the risks of severe adverse events (AEs) associated with these vaccines. The researchers found that the reported risks of systemic AEs were consistent across both RCT and VAERS data. However, for severe AEs reported in VAERS, the reported risks of thrombosis and Guillain-Barré Syndrome (GBS) after Janssen vaccine were highest. The study also found that the reported risk of shingles after the first dose of Moderna vaccine was highest, followed by the second dose of the Moderna vaccine.

Key Takeaways:

  • The study compared the safety of COVID-19 vaccines from Pfizer, Moderna, and Janssen using both RCTs and VAERS data.
  • The reported risks of systemic AEs were consistent across both RCT and VAERS data.
  • The reported risks of thrombosis and GBS after Janssen vaccine were highest for severe AEs reported in VAERS.
  • The reported risk of shingles after the first dose of Moderna vaccine was highest, followed by the second dose of the Moderna vaccine.
  • The reported risk of myocarditis was higher after the second dose of Pfizer and Moderna vaccines.
  • The reported risk of anaphylaxis was higher after the first dose of Pfizer vaccine.
  • The study's limitations include the inherent biases of spontaneous reporting system data and the lack of comparison with other active vaccine safety surveillance systems.

Statistics:

  • 559,717 VAERS reports between December 14, 2020, and September 17, 2021, were reviewed.
  • The study found that the reported risks of systemic AEs were consistent across both RCT and VAERS data.
  • The reported risk of thrombosis after Janssen vaccine was 1.09 per 100,000 (VAERS).
  • The reported risk of GBS after Janssen vaccine was 0.63 per 100,000 (VAERS).
  • The reported risk of shingles after the first dose of Moderna vaccine was 2.54 per 100,000 (VAERS).
  • The reported risk of shingles after the second dose of Moderna vaccine was 2.31 per 100,000 (VAERS).
  • The reported risk of myocarditis after the second dose of Pfizer vaccine was 1.15 per 100,000 (VAERS).
  • The reported risk of anaphylaxis after the first dose of Pfizer vaccine was 2.36 per 100,000 (VAERS).

Sources:

  • Comparability of clinical trials and spontaneous reporting data regarding COVID-19 vaccine safety. Scientific Reports, 2022, 12(1):1-8. (Scientific Reports - http://www.nature.com/srep/index.html).
  • University of Pennsylvania, Department of Biostatistics, Epidemiology and Informatics.