ARTICLE | Regulation

FDA will require data similar to BLA standard for COVID-19 emergency authorization

FDA officials vow rigorous standards for COVID-19 vaccines

September 10, 2020 11:03 PM UTC

FDA will set a high bar for issuing an emergency use authorization for COVID-19 vaccines and will present any EUA request to an advisory committee before deciding on the application, senior agency officials said Thursday.

“If we are going to do an emergency use authorization, it’s going to really be like an emergency use authorization ‘plus,’” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), said at a webinar convened by the Duke-Margolis Center for Health Policy. On the continuum between an EUA and a BLA, “it’s going to be closer to the BLA,” he said. ...