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Advisory Committee Meeting

Event Title
Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Announcement
March 06-07, 2019

Scheduled

Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Announcement - 03/06/2019 - 03/07/2019


Date:
March 06-07, 2019
Time:
March 06, 2019
Location:
Event Location
White Oak Campus: The Great Room
The Great Room

10903 New Hampshire Ave
Bldg 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
United States



Center Date Time Location
CBER March 6, 2019 8:00 a.m. to 4:30 p.m. FDA White Oak Campus,
White Oak Conference Center,
Building 31, Great Room (Rm. 1503),
10903 New Hampshire Avenue,
Silver Spring, MD 20993
CBER March 7, 2019 8:30 a.m. to 4:45 p.m. FDA White Oak Campus,
White Oak Conference Center,
Building 31, Great Room (Rm. 1503),
10903 New Hampshire Avenue,
Silver Spring, MD 20993

Agenda
On March 6, 2019, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019 to 2020 influenza season. Also under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Immunoregulation (LIR) and the Laboratory of Retroviruses (LR), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.

On March 7, 2019, under Topic III, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur.

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, the background material will be made publicly available at the location of the advisory committee meeting, and the background material 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.

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 February 27, 2019.
  • On March 6, 2019, oral presentations from the public will be scheduled between approximately 11:10 a.m. and 11:55 a.m. for the influenza strain selection portion of the meeting and 3 p.m. to 3:15 p.m. for the overview portion of the LIR/LR Site Visit. On March 7, 2019, oral presentations from the public will be scheduled between approximately 1:15 p.m. to 2:15 p.m. for the Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur portion of the meeting.

Closed Committee Deliberations: On March 6, 2019, from 3:25 p.m. to 4:30 p.m., the meeting will be closed to Public to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).

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 February 19, 2019. 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 February 20, 2019.

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

For those unable to attend in person, the meeting will also be available via webcast.

Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. While CBER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The link for the webcast (both days) is available at:
https://collaboration.fda.gov/vrbpac032019/

Contact Information

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.

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.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 Serina Hunter-Thomas at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions; visitor parking and security can be accessed at the Public meetings at White Oak main page.

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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Official FR Notice

Recorded Webcast

  1. Day 1
    1. Part 1
    2. Part 2
    3. Part 3
  2. Day 2
    1. Part 1
    2. Part 2
    3. Part 3


Event Materials

  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Waiver: William B. Messer, M.D., Ph.D. (184.19 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Acknowledgment of Financial Interests: William B. Messer, M.D., Ph.D. (161.29 KB)
  • Biological Products Advisory Committee March 6 - 7, 2019 Meeting FDA Briefing Document- Dengue Tetravalent Vaccine, Live (Proposed Trade Name: Dengvaxia) (821.84 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Briefing Document- WHO Website Links (159.36 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Draft Roster- Revised (308.60 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Non-FDA Briefing Document- Dengvaxia- Tetravalent, Live-Attenuated Viral Vaccine against Dengue Serotypes 1, 2, 3 and 4
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Draft Roster (306.19 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Draft Agenda- Revised (319.85 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Draft Agenda (297.07 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6-7, 2019 Meeting Final Roster (151.99 KB)
  • Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Summary Minutes (153.67 KB)

  • 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.

    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 agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

    Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

    Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).