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Exploring the Safety Profiles of the COVID-19 Vaccines in VigiBase Using vigiGroup: a Novel Method for Clustering ICSRs: An International Journal of Medical Toxicology and Drug Experience
Drug Safety ; 44(12):1463, 2021.
Article in English | ProQuest Central | ID: covidwho-1543401
ABSTRACT
Background/

Introduction:

Disproportionality analysis [1, 2] has been a stalwart of post marketing safety surveillance, however it has some drawbacks. vigiGroup [3, 4] is a novel ICSR clustering method which can complement disproportionality analysis, and we present its first application to prospective monitoring of a drug's safety profile, by incorporating its use into our surveillance activities of the COVID-19 vaccines. Objective/

Aim:

We aim to explore and develop the utilisation of vigiGroup as a tool for prospective monitoring of COVID-19 vaccine safety reports in VigiBase.

Methods:

VigiBase receives tens of thousands of adverse event reports per week for all COVID-19 vaccines collectively. Each week, the vigiGroup algorithm has been applied to cluster the accumulated ICSRs of COVID-19 vaccines. The algorithm was applied independently for each vaccine, but also grouping the vaccines by platform. Our multidisciplinary team of pharmacovigilance experts and data scientists have developed powerful data visualisation tools to rapidly explore the evolving safety profile of the vaccines, as well as to strengthen the hypotheses generated with traditional disproportionality analysis.

Results:

A number of potential safety signals have been identified directly using the tools we have developed in tandem with the vigiGroup clustering algorithm. These include appendicitis and hearing loss/tinnitus for all COVID-19 vaccines and delayed local reactions to the Moderna vaccine, which were identified in a vigiGroup interface with the aid of imbedded data visualisation tools. Several more signals have been strengthened by further incorporating vigiGroup as a complementary tool to traditional disproportionality analysis. We have moreover demonstrated the efficacy of the algorithm and our tools by recovering labelled adverse reactions, such as hypersensitivity and anaphylaxis, and emerging safety signals, e.g. myocarditis, for all of the vaccines.

Conclusion:

The use of vigiGroup clustering has been explored by pharmacovigilance experts at the Uppsala Monitoring Centre and has been found to be a promising new tool for post-marketing drug safety surveillance. The vigiGroup algorithm and data visualisation tools are being iteratively developed as the prospective monitoring of COVID-19 vaccines continues.
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Collection: Databases of international organizations Database: ProQuest Central Topics: Vaccines Language: English Journal: Drug Safety Year: 2021 Document Type: Article

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Collection: Databases of international organizations Database: ProQuest Central Topics: Vaccines Language: English Journal: Drug Safety Year: 2021 Document Type: Article