Comparison of adverse drug reactions among four COVID-19 vaccines

 Maria Abbattista, Ida Martinelli, Flora Peyvandi

DOI:  

https://doi.org/10.1111/jth.15493

PDF: https://onlinelibrary.wiley.com/doi/epdf/10.1111/jth.15493

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi:10.1111/jth.15493

Summary

Background

Real-world experience with adenoviral vector vaccines against COVID-19 raised some safety concerns. Cases of cerebral vein thrombosis (CVT) associated with thrombocytopenia have been observed after the first dose of the adenoviral vector vaccines CHADOX1 NCOV-19 and AD26.COV2.S.

Objectives

To assess the reporting rate of CVT as adverse drug reaction (ADR) for the COVID-19 vaccines authorized in Europe.

Patients and Methods

This observational study assessed the CVT reporting rate attributed to four COVID-19 vaccines authorized in Europe, namely Tozinameran (Pfizer-Biontech), CX-024414 (Moderna), CHADOX1 NCOV-19 (AstraZeneca) and AD26.COV2.S (Janssen). Data on thrombotic ADRs reported on EudraVigilance database between January 1st, 2021 and July 30th, 2021, were collected. ADRs referring to CVT were identified. The reporting rate of CVT was expressed as 1 million individual vaccinated-days with 95% confidence interval. Finally, an observed-to-expected (OE) analysis was performed.

Results

The reporting rate of CVT per 1 million person vaccinated-days was 1.92 (95% CI, 1.71-2.12) for Tozinameran, 5.63 (95% CI, 4.74-6.64) for CX-024414, 21.60 (95%CI, 20.16-23.11) for CHADOX1 NCOV-19, and 11.48 (95%CI, 9.57-13.67) for AD26.COV2.S. CVT occurred alongside with thrombocytopenia for the four vaccines. The OE ratio was greater than one for all four vaccines, both with the lowest and the highest CVT background incidence.

Conclusions

This report on EudraVigilance data strengthens anecdotal findings on CVT following COVID-19 vaccinations. Although EMA released alert only for CHADOX1 NCOV-19 and AD26.COV2.S, also Tozinameran and CX-024414 are complicated by CVT, albeit to lesser extent.

https://onlinelibrary.wiley.com/doi/10.1111/jth.15493