FDA’s ongoing commitment to transparency for COVID-19 EUAs

FDA Commissioner Stephen M. Hahn, MD, says the agency’s emergency use authorizations (EUAs) play an important role in the nation’s battle against COVID-19 and other public health emergencies. To help strengthen the public’s confidence in FDA’s assessment of scientific data and the appropriate use of authorized products, FDA’s drug and biological product centers will publicly post their reviews of the scientific data and information that support the issuance, revision, or revocation of EUAs for all drug and biological products, to the extent allowable by law, Hahn says. This transparency will include vaccines; FDA has already posted certain scientific review documents, such as for an EUA revocation and an EUA authorization. FDA will also publish information from EUA review documents as appropriate, but it may redact certain information that is protected from disclosure under the law. FDA also formed a Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the development, licensure, and authorization of COVID-19 vaccines. In addition, FDA is developing educational materials to help the public understand the different regulatory and scientific steps involved in vaccine or drug development, including explaining the investigational new drug process and the role of data safety monitoring boards.