Dr. Kathleen Dooling ACIP Work Groups National

Transcript:Dr. Kathleen Dooling ACIP Work Groups National:
Dr. Kathleen Dooling ACIP Work Groups National Center for Immunization & Respiratory Diseases Division of Bacterial Diseases Herpes Zoster Work Group Lead Division of Viral Diseases, CDC Outline Work Groups: Purpose & Composition Rules of Engagement: Conflicts of interest Confidentiality Working with the pharmaceutical industry Work Group members: Roles and Responsibility Triggers to Establish a Work Group New or expanded vaccine license anticipated Work Groups usually begin reviewing data at least 12-24 months prior to a potential decision on licensure New critical data regarding safety/effectiveness, or programmatic issues etc. Updates to existing recommendations anticipated Regular review Existing ACIP recommendations should be reviewed at least every 7 years, and either revised, renewed, or retired with a vote by ACIP So you need a NITAG Work Group… Who? Internal External What needs to be in place to start working? Composition of ACIP Work Groups ACIP voting members (≥2, one serves as WG Chair) ACIP ex-officio members (eg. regulatory, gov. research) ACIP liaison representatives (eg. American Academy of Pediatrics, Council of State and Territorial Epidemiologists) Invited consultants (external experts) CDC staff CDC WG Lead Subject matter experts in pathogen, vaccine safety, and program So you need a NITAG Work Group… Who? What should be in place to start working? Terms of Reference Declaration of interests/Conflict of interest Confidentiality Expectation of role/responsibility Terms of Reference for an ACIP Work Group Each Work Group operates under specific Terms of Reference (TORs) determined by the WG Chair and WG Lead at the time the WG is formed: Background Purpose or Objectives Activities Updated annually or when major changes to activities Shared by Work Group during ACIP presentations Identifying Conflicts of Interest ACIP Work Group members serve a key scientific role in support of vaccine policy development. Conflicts of interest could interfere with the effective functioning of a Work Group. To avoid undue influence or the appearance/perception of a conflict of interest, screening is conducted upon establishment of the Work Group and annually Balance of ensuring limited potential conflicts of interest and need for expertise in the subject matter Goal is to be transparent about potential conflicts What is a Conflict of Interest for WG members? Examples where a conflict of interest should prohibit Work Group membership: A person or their immediate family is employed by a vaccine manufacturer or its parent company. A person holds a paid advisory or consulting role with a vaccine manufacturer to