FDA Schedules COVID-19 Vaccine Review for Dec. 10. 2020

November 23, 2020
BioPharm International Editors

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Dec. 10, 2020, to discuss a request from Pfizer and BioNTech Manufacturing GmbH for emergency use authorization (EUA) of BNT162b2, the companies’ COVID-19 vaccine.

The VRBPAC—which includes scientific and public health experts, consumer and industry representatives, and sometimes a patient representative—provides advice to the agency and may provide advice on the safety and effectiveness data submitted in the EUA request. FDA makes the final decision on authorizing a vaccine for emergency.

In terms of timing of the VRBPAC meeting following the submission of the EUA request, this amount of time will allow 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

“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, in a statement. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted.”

Hahn further noted that the while the time needed for FDA review was not certain “FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”

“A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19,” Hahn noted in the statement.

The agency will make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting, FDA reported.

In the Nov. 20, 2020 statement, FDA reported the agency’s intent to share details of the meeting in the Federal Register during the week of Nov. 23, including information about a public docket for submission of comments. At that time, public comments can be submitted. The agency said the meeting will be livestreamed on the agency’s YouTube, Facebook, and Twitter channels; and will be webcast from the FDA website.

Source: FDA