Centers for Disease Control and Prevention’s Immunization Safety Office scientific agenda
Published Date:February 2011
Corporate Authors:National Center for Emerging and Zoonotic Infectious Diseases (U.S.). Division of Healthcare Quality Promotion. Immunization Safety Office
Description:Overview -- Section 1. Emerging Issues and Core, Required Scientific Activities -- -- Section 2. Vaccine Safety Public Health and Clinical Guidance Capacity -- A. Infrastructure for Vaccine Safety Surveillance: Vaccine Adverse Event Reporting System (VAERS) -- B. Infrastructure for Vaccine Safety Surveillance and Research: Vaccine Safety Datalink (VSD) Project -- C. Epidemiologic and Statistical Methods for Vaccine Safety -- D. Laboratory Research -- E. Genomics and Vaccine Safety -- F. Case Definitions for Data Collection, Analysis, and Presentation for Adverse Events Following Immunization (AEFI) -- G. Vaccine Safety Clinical Practice Guidance -- -- Section 3. 5-Year Research Needs -- A. Specific Vaccine Safety Questions (Table 3A) -- B. Vaccines and Vaccination Practices (Table 3B) -- C. Special Populations (Table 3C) -- D. Clinical Outcomes (Table 3D) -- E. Methods for Identifying the ISO’s 5-Year Research Needs (Table 3E) -- -- Section 4. Post-Script: Additions Following NVAC Review -- Acknowledgements -- References -- Appendix A. List of Abbreviations -- Appendix B. Glossary of Terms -- Appendix C. Summary of NVAC Recommendations.
In response to a 2005 Institute of Medicine (IOM) recommendation (IOM, 2005), and to guide the scientific direction of the Centers for Disease Control and Prevention’s (CDC’s), Immunization Safety Office (ISO), a draft ISO Scientific Agenda (referred to as the Agenda) was developed to be implemented over a 5-year period. ISO received input from experts during three planned meetings with external, federal, and industry scientists, and vaccine manufacturers’ representatives. ISO also gathered input from other partners and CDC experts in vaccine safety. A companion background document highlights the differences between the initial 2008 draft Scientific Agenda and this finalized 2010 Scientific Agenda. The background to the 2008 draft also provides additional information on the ISO research and surveillance infrastructure, and the Agenda’s rationale and scope. The entire process used is described in an earlier document that can be found at: http://www.cdc.gov/vaccinesafety/00_pdf/agenda_background_080321.pdf.
At the request of CDC, the National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group advised on the content and priorities of the Agenda. CDC finalized the Agenda and responded to NVAC feedback. The NVAC Vaccine Safety Working Group reviewed the Agenda and made 32 recommendations in three categories: general, capacity, and research needs recommendations. The prioritization criteria included significance of the exposure to a vaccine, prevalence of the adverse health event following immunization, public concern, scientific concern and degree to which further study is warranted, impact on policy, and feasibility of the study. A summary of the NVAC recommendations is included in Appendix C: Summary of NVAC Recommendations. The NVAC recommendations to the Agenda were approved by the Assistant Secretary for Health of the US Department of Health and Human Services (HHS) and sent to CDC on July 29, 2009 (NVAC, 2009).
The Agenda was informed by NVAC’s request for broad public engagement to identify public concerns and priorities related to vaccine safety research. Public input was solicited in four ways: 1) at community meetings held in Birmingham, Alabama, Ashland, Oregon, and Indianapolis, Indiana; 2) at a writing group meeting in Salt Lake City, Utah; 3) at a stakeholder meeting held in Washington, DC; and 4) by written comments solicited through two notices in the Federal Register.
CDC/ISO has incorporated many of NVAC’s recommendations into the Agenda and is working with the National Vaccine Program Office (NVPO) to consider the best way to address activities included in the Agenda that are beyond the scope of ISO. Considerations in implementing the Agenda include resources, feasibility, advances in science, and alignment with CDC/ISO missions.
HHS has developed a Strategic National Vaccine Plan (http://www.hhs.gov/nvpo/vacc_plan/), which was drafted concurrently with this ISO Agenda. The ISO Agenda was written to be consistent with the draft national plan.
Separate from this process, the NVAC Vaccine Safety Working Group has also taken up a second charge to review the current federal vaccine safety system and develop a white paper describing the infrastructure needs for a federal vaccine safety system that includes CDC (NVAC, 2009) (www.hhs.gov/nvpo/nvac/documents/vfwgwhitepaper20080410.pdf).
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