Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: a pharmacovigilance analysis of WHO international database

Kim, Min Seo and Jung, Se Yong and Ahn, Jong Gyun and Park, Se Jin and Shoenfeld, Yehuda and Kronbichler, Andreas and Koyanagi, Ai and Dragioti, Elena and Tizaoui, Kalthoum and Hong, Sung Hwi and Jacob, Louis and Salem, Joe-Elie and Yon, Dong Keon and Lee, Seung Won and Ogino, Shuji and Kim, Hanna and Kim, Jerome H. and Excler, Jean-Louis and Marks, Florian and Clemens, John D. and Eisenhut, Michael and Barnett, Yvonne A. and Butler, Laurie T. and Ilie, Cristian and Shin, Eui-Cheol and Shin, Jae Il and Smith, Lee (2021) Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: a pharmacovigilance analysis of WHO international database. Journal of Medical Virology. ISSN 1096-9071

[img] Text
Accepted Version
Restricted to Repository staff only until 28 October 2022.
Available under the following license: Creative Commons Attribution Non-commercial No Derivatives.

Download (974kB) | Request a copy
[img] Text (Word version)
Accepted Version
Restricted to Repository staff only until 28 October 2022.
Available under the following license: Creative Commons Attribution Non-commercial No Derivatives.

Download (553kB) | Request a copy
Official URL: https://doi.org/10.1002/jmv.27424

Abstract

Background- Two mRNA vaccines developed by Pfizer-BioNTech and Moderna are being roll-out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, the previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly standing out the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable more relevant assessment for the safety of mRNA vaccination. Methods- We designed a comparative safety study between 18,755 and 27,895 individuals reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of diverse span of AEFIs for the vaccines. Results- The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47–65.54) and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62–24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. Conclusions- This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.

Item Type: Journal Article
Keywords: COVID-19, MRNA vaccine, Influenza vaccine, Safety, Post-implementation surveillance, VigiBase
Faculty: COVID-19 Research Collection
Faculty of Science & Engineering
SWORD Depositor: Symplectic User
Depositing User: Symplectic User
Date Deposited: 01 Nov 2021 11:15
Last Modified: 17 Jan 2022 15:23
URI: https://arro.anglia.ac.uk/id/eprint/707066

Actions (login required)

Edit Item Edit Item