FDA Issues Guidance for COVID-19 Vaccine Authorization

By Miranda Greenberg -

October 8, 2020

The US Food and Drug Administration (FDA) has issued guidance 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, a move supported by the pharma industry.

The guidance specifies the data and information needed to support an investigational vaccine to prevent COVID-19, including: chemistry, manufacturing, and controls (CMC) information; nonclinical data and information; clinical data and information; and administrative and regulatory information. In addition, the guidance provides recommendations regarding key information and data that should be submitted in a relevant investigational new drug application or cross-referenced master file prior to submission of an EUA request in order to facilitate FDA’s complete and timely review of such a submission. The guidance also discusses FDA’s current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate.

Pharmaceutical industry groups, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) support the further guidance being provided by the FDA. 

“PhRMA supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines,” said PhRMA President and CEO, Stephen J. Ubl, in an October 6, 2020 statement. “To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time. We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

Dr. Michelle McMurry-Heath, President and CEO of BIO also supports the FDA in releasing the guidance. The FDA’s action followed Dr. McMurry-Heath’s call to US Health and Human Services Secretary Alex Azar to release the guidance in order to help those developing a vaccine and to promote greater public confidence in future Covid-19 vaccines.

“In the midst of a pandemic, transparency and collaboration are critical if we are going to quickly and safely eradicate this global health threat,” said Dr. McMurry Heath in an October 6, 2020 statement.  “That is why we recently called for the public release of any new FDA guidance concerning emergency use authorization for Covid-19 vaccines. The release of this information is vital for the scientists and researchers working on the frontlines combating this pandemic, as well as for building public confidence in the scientific solutions our industry is committed to delivering.”

Source: US Food and Drug Administration, Pharmaceutical Research and Manufacturers of America, and Biotechnology Innovation Organization