FDA launches FAERS dashboard for COVID-19 therapies
The US Food and Drug Administration (FDA) has launched a new public dashboard to track adverse event reporting for drugs and therapeutic biological products that have received emergency use authorization (EUA) to treat COVID-19.
The FDA Adverse Event Reporting System (FAERS) public dashboard for COVID-19 EUA products will be updated weekly, according to FDA’s landing page for the new initiative.
In its inaugural week, the dashboard indicates that a total of 8,627 FAERS reports have been made, with 5,000 judged to be serious and an additional 1,404 reporting a death. Just over 3,000 of the total reports have been made in 2021.
In all, 5,526 of the FAERS reports have been directly submitted to FDA through its MedWatch program, either by consumers or by health care professionals.
Though FDA emphasized that the dashboard is part of its ongoing commitment to public access to data and to transparency during the pandemic, the agency also noted some important limitations to the dashboard and to FAERS data in general.
First, some reports duplicate each other, while others are incomplete. “Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny,” wrote the agency.
Also, said FDA, reporting an adverse event does not establish that the authorized drug or biologic caused the event. As with other disease conditions, “The information in these reports reflects only the reporter’s observations and opinions,” noted FDA.
Additionally, the FAERS submissions are unverified. Finally, occurrence rates or incidence cannot be estimated from data contained in FAERS reports, and the data do not speak to the safety of the authorized product.
The dashboard also allows data to be sorted and portrayed according to type of reporter, reporter region, seriousness, age group and sex.