Comments currently being accepted
The Center for Biologics Evaluation and Research’s Vaccines Advisory Committee will meet on October 22 10:00 AM – 5:00 PM ET to discuss the development, authorization, and licensure of vaccines to prevent COVID-19. The meeting will be held at this website. Registration isn’t required.
Public comments can be submitted through October 14. I submitted comments urging the Committee to ensure that no shortcuts are taken with the approval process for the SARS CoV2 vaccines. The stakes are too high. The only way out of this pandemic is to make sure that the public has full confidence that the vaccines are both safe and effective. The best way to make that happen is to make sure the FDA requires the vaccine manufacturers to follow tried and true standardized approval processes.
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. No specific application will be discussed at this meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, any background material will be made publicly available at the time of the advisory committee meeting, and additional materials will be posted on FDA’s website after the meeting.
Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2020-N-1898. The docket will close on October 15, 2020.
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. URL is https://www.regulations.gov/comment?D=FDA-2020-N-1898-0001