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Incidence of ischaemic Stroke Following ComirnatyTM Administration: Comparison of Data from ASST GOM Niguarda and FAERS: An International Journal of Medical Toxicology and Drug Experience
Drug Safety ; 45(10):1173-1174, 2022.
Article in English | ProQuest Central | ID: covidwho-2046394
ABSTRACT

Introduction:

Although the mechanism of neurological complications after COVID-19 vaccination has not been precisely explained, it could be attributed to the inflammatory state triggered by COVID-19 vaccine as in the course of COVID-19 viral infection. This condition induces disseminated intravascular coagulation (DIC) in combination with vascular endothelial dysfunction, leading to stroke of the large vessels. This hypothesis may be the main cause of DIC, especially in mRNA-based vaccines, whose mechanism involves delivery of the mRNA code of the spike protein to human cells. Cellular synthesis of the spike protein stimulates the immune system to recognize and store it for future attack. Based on this hypothesis, the inflammatory state triggered by the vaccine can be considered the main pathway for neurological complications of COVID-19 vaccine.

Objective:

The aim of this work is to analyse the incidence of ischaemic stroke risk following administration of the ComirnatyTM vaccine in ASST GOM Niguarda, an Italian hospital based in Milan, and to compare it with data from FAERS database.

Methods:

The Reporting Odds Ratio (ROR) was calculated in order to evaluate a possible correlation between the risk of ischaemic stroke and Comirnatyvaccine administration in the period of January-December 2021. For this purpose, we consulted FAERS public domain database that allows you to search information relating to adverse events reported to the FDA.

Results:

From reports of adverse events of ComirnatyTM vaccinated patients at ASST GOM Niguarda hospital, it was observed that after administration of this vaccine there is a correlation with the risk of developing ischaemic stroke mainly in over 65 years old patients (OR = 1.26;95% CI 0.17-9.13;z = 0.230;p value = 0.8182) when comparing the data with other vaccines. These data match the data obtained from FAERS (OR 1.29;95% CI 0.85-1.96;z = 1.205;p value = 0.228), confirming the data collected in ASST GOM Niguarda.

Conclusion:

The data extrapolated from this analysis conducted at ASST GOM Niguarda mirror those obtained from the FAERS database with a comparable significance index (p value). In conclusion, the possible correlation between ComirnatyTM vaccine administration and the development of ischaemic stroke as an adverse event was confirmed.
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Collection: Databases of international organizations Database: ProQuest Central Type of study: Observational study Language: English Journal: Drug Safety Year: 2022 Document Type: Article

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Collection: Databases of international organizations Database: ProQuest Central Type of study: Observational study Language: English Journal: Drug Safety Year: 2022 Document Type: Article