BRIEF—FDA's pledge on oversight of vaccines

12 September 2020

The US Food and Drug Administration Friday continued to take action in the ongoing response to the COVID-19 pandemic.

“We are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines,” declared a statement from Dr Stephen Hahn, FDA Commissioner and Dr Peter Marks, Director, Center for Biologics Evaluation and Research

In a new FDA Voices titled,  The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, agency leaders explain that they are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines.

The FDA also intends to issue additional guidance shortly to provide sponsors of requests for  Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA.