FY17 Announcement of Anticipated Availability of Funds for Safety Research of Currently Recommended Immunizations in the United States and Other Vaccine Prototypes

Description

The National Vaccine Program Office (NVPO) provides strategic direction for the coordination of the vaccine and immunization enterprise through the implementation of the National Vaccine Plan (NVP). With respect to Goal 2: Enhance the Vaccine Safety System of the NVP, NVPO specifically provides guidance and coordination for vaccine safety-related activities through the NVPO-led Immunization Safety Task Force (ISTF). The ISTF was formed in 2009 to better coordinate all federal entities engaged in U.S. vaccine safety activities and includes subject matter experts from HHS (the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Indian Health Service (IHS), the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA)), as well as the Veterans Administration and the Department of Defense. In this capacity, the ISTF is able to identify scientific and programmatic opportunities to improve vaccine safety monitoring and research. NVPOs cooperative agreement program is a mechanism to collaborate with one or more institutions or organizations, including state and local public health departments and HHS Regional Offices, to conduct research that will strengthen the current U.S. vaccine safety enterprise. This program encourages collaborative interdisciplinary proposals to maximize the results and impact of the research project. This NVPOs cooperative agreement program (NV-VSR-17-001) is one of several federally-funded opportunities for vaccine safety research, including PA-15-312/ PA-15-313, under the title “Research to Advance Vaccine Safety (R01/R21)” funded by the NIH and the CDC. NV-VSR-17-001 is intended to offer support for exploratory and programmatic vaccine safety research, as articulated above, that can be completed within one year. Vaccine safety projects previously awarded by NVPO included two cooperative agreements on the topics of vaccine safety research and prevention of adverse events after vaccine administration. The first project analyzed fever after vaccination in babies who received their first pertussis immunization and had been born to vaccinated mothers compared to those who had been born to unvaccinated mothers. The second project focused on developing an evidence-base intervention to reduce pain or the perception of pain from a vaccine injection. NVPOs scientific staff will have substantial involvement in carrying out the activity proposed by the award that is above and beyond the normal stewardship role in awards, as described below: • Provide guidance and support in the design and development of the research project; • Serve as a resource to provide scientific/programmatic support during the conduct of the research by participating in the design of the activities, and assisting with access to vaccine safety stakeholders; • Have frequent communications with the principal investigator (PI) and study team to discuss progress of research, and determine next steps; and • Participate in the preparation of publications and public presentations of the data obtained under this cooperative agreement.

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