In recent developments, the U.S. Food and Drug Administration (FDA) has rolled out a new public dashboard, called the FDA Adverse Event Reporting System (FAERS) to track COVID-19 therapeutics which have received an Emergency Use Authorization (EUA).
The FAERs dashboard is a highly interactive online tool that will provide weekly updates of adverse event reports germane to the medical and therapeutic biological EUA products used for COVID-19 treatment. These reports are generally submitted to the dashboard by healthcare providers, pharmaceutical companies, and other consumers.
According to reliable sources, the FAERS dashboard has recorded around 3000 reports in the year 2021 alone. Moreover, the platform indicated that around 8627 reports were made in its inaugural week, which included 5000 adverse cases and 1404 deaths.
FDA claimed that the newly launched FAERS dashboard is a part of its commitment towards public access of data as well as increasing data transparency amid the ongoing COVID-19 pandemic. However, the agency indicated a few significant limitations to the platform.
For instance, an adverse medical event report does not necessarily specify the safety profile of the relevant drug or biologic in question and is merely a citation of the reporter’s opinions and observations. The agency also pointed out the occurrence of duplication in the system along with a few reports missing necessary information.
Further elaborating on the limitations of the dashboard, the FDA stated that the FAERS submissions are unverified and the incidence and occurrence rates of a EUA product cannot be deduced from the data contained in the reports.
On the contrary, the dashboard can allow information to be organized and displayed based on the type of data reported, adversity of event, region of the reporter, age group, and gender.
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