FDA Covid Vaccines & Related Biological Products Advisory Committee Meet Oct 22

Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 22, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

Meeting Materials
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.

• Written submissions may be made to the contact person on or before October 15, 2020.
• On October 22, 2020, oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. EST.

Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 7, 2020. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 8, 2020.

Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.

The online web conference meeting will be available at:
Main link – https://collaboration.fda.gov/vrbpac102220/
Overflow link – https://collaboration.fda.gov/vrbpac102220overflow/

Contact Information

• Prabhakara Atreya, 240-506-4946, e-mail: Prabhakara.Atreya@fda.hhs.gov
  or Monique Hill, 301-796-4620, e-mail: Monique.Hill@fda.hhs.gov
• FDA Advisory Committee Information Line:
  1-800-741-8138 (301-443-0572 in the Washington, DC area) Please call the Information Line for up-to-date information on this meeting.
• For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the meetings main page or call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Prabhakara Atreya at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement