FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

The U.S. Food and Drug Administration 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 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 in order to make a decision about whether to authorize this vaccine.

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."

Janet Woodcock, M.D., Acting Commissioner, FDA

The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed.

The members of the VRBPAC are independent, scientific and public health experts from around the country who provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request. However, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.

In terms of timing for convening the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.

While the FDA cannot predict how long its ongoing evaluation of the data and manufacturing information will take following the VRBPAC meeting to make a decision on the request for an EUA, the agency will review the request as expeditiously as possible, taking into consideration the discussion by the advisory committee, while still doing so in a thorough and science-based manner.

The FDA intends to issue a Federal Register notice as soon as possible with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted. These comments will be reviewed by the FDA.

The FDA intends to livestream the VRBPAC meeting on the agency's YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.