FDA Commits to Transparency in EUA Reviews

As COVID-19 vaccine candidates moved closer to filings for Emergency Use Authorizations (EUAs), FDA Commissioner Stephen M. Hahn committed the agency to transparency in the review and issuance of EUAs for drug and biological products, including vaccines, as COVID-19 treatments.

In a Nov. 17, 2020 statement, Hahn stated the agency would “publicly post their reviews of the scientific data and information supporting the issuance, revision, or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response after the disclosure review and process is complete.”

The statement reflects FDA efforts to bolster public confidence in healthcare authorities for pandemic-related decisions. “In particular, we recognize that disclosing information from the scientific review documents supporting the issuance, revision or revocation of EUAs for drugs and biological products, including vaccines, will contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products,” Hahn noted in the statement.

Hahn reiterated the underlying legislation that authorizes FDA to issue an EUA in emergency situations when there are no adequate, approved, and available alternative treatments. The statement noted the agency evaluates available scientific evidence that is available on the product’s safety and effectiveness to determine if the product may be effective for its proposed authorized uses and if the potential benefits outweigh its known and potential risks.

Source: FDA