FDA Sets Date for Advisory Meeting to Discuss Janssen COVID-19 Vaccine EUA

February 5, 2021
BioPharm International Editors

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

FDA announced on Feb. 4, 2021 that it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021 to discuss the request for emergency use authorization (EUA) for Janssen Biotech’s COVID-19 vaccine candidate.

“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 in order to make a decision about whether to authorize this vaccine,” said Acting FDA Commissioner Janet Woodcock, MD, in an agency press release.

While FDA does not have a timeline for how long the evaluation of the data and manufacturing information will take following the meeting, it will review the request as quickly as possible while considering the discussion by the advisory committee in a science-based manner, FDA said in the press release. Background materials to be used during the meeting will be available to the public two business days prior to the meeting.

“[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,” Woodcock said.

Source: FDA