FDA launches FAERS public dashboard for COVID-19 emergency use authorization products.

Covid-19 is currently in the news worldwide and that on a daily basis. With vaccinations now becoming more widely available, not only healthcare professionals are interested in post vaccination information. The public too is getting hungrier not only for information on vaccination success, but also on possible side effects even though these are minimal.

With that in mind, the US Food and Drug Administration (FDA) has launched a new public dashboard, allowing tracking of adverse event reporting for drugs treating Covid-19. The FAERS public dashboard is a highly interactive web-based solution, allowing extensive querying functionality. The FDA acknowledges though that there are limitations. One being that a report in FAERS does not necessarily mean that the drug in question actually caused the side effect. Other limitations include

  • FAERS can include duplicates and incomplete reports
  • Reports reflect only the reporter’s opinion and are not necessarily linked to the cause of the drug event as the event could have been triggered by other reasons.
  • Reports and their content have not been (medically) verified.
  • Rates of occurrence cannot be established with reports.

Despite these limitations, the FDA emphasises that improving data access and transparency were core concepts that drove FAERS development. The FDA anticipates that increased transparency will lead to more detailed and complete report submissions by health care professionals and the public.

The dashboard itself provides the ability to display data according to regions, seriousness, age group and others. The below example shows a report by report type.

Another example shows a report by age group (data view as of March 11, 2021).

An easier representation of the same data is also available in graphic view (data as of March 11, 2021):

The user interface is very flexible and allows further drill down into the data, such as viewing of a specific age group or year.

In summary

FDA’s Adverse Event Reporting System (FAERS) is a good example of how agencies can increase transparency of adverse event reporting for medical professionals as well as the public. The FDA states that “Complete and detailed reports are immensely helpful to the agency when identifying safety signals”. Sharing additional information during difficult times such as the Covid-19 pandemic will be appreciated and can only lead to better safety monitoring and ultimately to better medicinal products, benefiting all patients.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

%d bloggers like this: