The Food and Drug Administration (FDA) has issued recommendations regarding the issuance of emergency use authorization (EUA) for investigational vaccines intended to prevent coronavirus disease 2019 (COVID-19).
The new guidance describes the information and data needed to support the authorization, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory administration information. In a statement, the Agency noted that any assessment regarding an EUA would be made on a case-by-case basis.
According to the FDA, data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen. The Agency will also not consider supporting an EUA request for an investigational vaccine without phase 3 data that include the following:
- Local and systemic solicited adverse reactions collected for the protocol-defined duration of follow-up in an adequate number of individuals to characterize reactogenicity;
- All safety data, including well over 3000 vaccine recipients followed for serious adverse events and adverse events of special interest for at least 1 month after completion of a full vaccination regimen;
- A sufficient number of cases of severe COVID-19 among participants to support low risk for vaccine-induced enhanced respiratory disease.
Additionally, the EUA request should include subgroup analyses of safety and efficacy stratified by prior infection status, as well as a plan for active follow-up for safety among individuals who receive the vaccine under the EUA.
The FDA published the new guidance ahead of the Vaccines and Related Biological Products Advisory Committee meeting, which is scheduled for October 22nd. The expert panel will discuss the general development, authorization and/or licensure of COVID-19 vaccines.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.”
For more information visit fda.gov.
FDA in brief: FDA issues guidance on emergency use authorization for COVID-19 vaccines. The U.S. Food and Drug Administration. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-guidance-emergency-use-authorization-covid-19-vaccines. Accessed October 7, 2020.