FDA Unveils New Adverse Event Tool for Authorized COVID-19 Products

The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs).

The new section of the FDA Adverse Event Reporting System (FAERS) is meant to expand access to FAERS data by the general public, allowing individuals to search out adverse event data reported to the agency.

The new dashboard for COVID-19 EUA products will also include weekly updates on drugs and therapeutic biological products used to treat the coronavirus. There were a total of 5,605 adverse events in 2020 in this category and 3,022 have been reported in 2021 so far.

The FDA points out that FAERS has significant limitations, including many duplicate and incomplete reports and unverified information, and it is not possible to establish the actual rates of occurrence of an adverse event based off the reports.

Access the new dashboard here: bit.ly/3rSJ6oD. ― Jason Scott