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Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO
Min Seo Kim1,2, Se Yong Jung3, Jong Gyun Ahn4
1College of Medicine, Korea University, Seoul, Republic of Korea.
Abstract:
Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who 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 a diverse span of AEFIs for the vaccines. 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. 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.
Insights
This study compared adverse events following immunization (AEFI) for mRNA COVID-19 vaccines versus influenza vaccines. mRNA COVID-19 vaccines showed a lower risk of serious AEFI compared to influenza vaccines, indicating a favorable safety profile.
Area of Science:
- Vaccinology
- Pharmacovigilance
- Immunology
Background:
- Emerging evidence on adverse events (AEs) following COVID-19 mRNA vaccination exists, but comparisons are often with unvaccinated individuals.
- Assessing mRNA vaccine safety requires comparison with other vaccinated populations for a more relevant safety assessment.
Purpose of the Study:
- To conduct a comparative safety study of mRNA COVID-19 vaccines against influenza vaccines.
- To evaluate and compare the risks of adverse events following immunization (AEFI) between mRNA COVID-19 and influenza vaccines using real-world data.
Main Methods:
- A disproportionality analysis was employed using data from VigiBase.
- The study analyzed 18,755 individuals who received mRNA COVID-19 vaccines and 27,895 who received influenza vaccines between January 1, 2020, and January 17, 2021.
- Comparative risks of various AEFIs were assessed using adjusted reporting odds ratios (ROR) and confidence intervals (CI).
Main Results:
- The safety profiles of mRNA COVID-19 and influenza vaccines were divergent.
- Systematic reactions like chills, myalgia, and fatigue were more common with mRNA COVID-19 vaccines, while injection site reactions were more prevalent with influenza vaccines.
- mRNA COVID-19 vaccines showed a higher risk of manageable cardiovascular complications (hypertensive crisis, supraventricular tachycardia) but a lower risk of neurological complications compared to influenza vaccines.
Conclusions:
- The study identified no significant safety concerns regarding mRNA vaccination in real-world settings.
- mRNA COVID-19 vaccines demonstrated a lower overall risk of serious adverse events following immunization compared to influenza vaccines.
- The findings support the favorable safety profile of mRNA COVID-19 vaccines when compared to influenza vaccines.
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