Background Analysis: US FDA Advisory Committee to Hear an Overview of CBER Research Program on DNA Viruses – NOV 8, 2018 (VRBPAC)

Announcement

The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for Thursday, November 8, 2018, from 11 am to 2:45 pm (US ET), to hear an overview of a research program in the FDA’s Center for Biologics Evaluation and Research (CBER).

Background

The Committee will hear an overview of research being conducted in CBER’s Laboratory of DNA Viruses (LDV).

The LDV’s research program has two major objectives:

1) facilitation of the development and evaluation of pandemic influenza vaccines; and

2) identification and evaluation of viral antigens and vaccination strategies important for the development of protective immunity against DNA viruses.

Major issues being addressed in the effort to facilitate evaluation of DNA virus vaccines include determining the role of individual antigens in the protective response to smallpox vaccination and the development of new methods and assays to quantify the immune response to vaccination.

Typically, the committee will hear an overview of the program(s), along with general information about the FDA’s site review program. This open session discussion of the program is usually followed by a closed session discussion in which the committee gives input and recommendations that assist the FDA in making resourcing/staffing decisions.

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: vaccine Indication: influenza

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.