Janssen's COVID-19 Vaccine Candidate Approaches Authorization

The U.S. Food and Drug Administration (FDA) announced on February 4, 2021, a digital meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. 

“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate to decide whether to authorize this vaccine,” said Acting FDA Commissioner Janet Woodcock, M.D., in a press statement.

“The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines so that the American public and medical community have trust and confidence in FDA-authorized vaccines.” 

The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.