FY15 Research, Monitoring and Outcomes Definitions for Vaccine Safety

OASH/ National Vaccine Program Office (NVPO) provides strategic direction for the coordination of the vaccine and immunization enterprise through the National Vaccine Plan (NVP) implementation. NVPO specifically provides guidance and coordination for all vaccine safety systems, activities and research studies in the U.S. through the Immunization Safety Task Force (ISTF). While engaging vaccine safety stakeholders through the ISTF, NVPO is able to identify gaps in vaccine safety monitoring and research. NVPO has launched this pilot cooperative agreement program to partner with an organization to conduct research that will strengthen the current U.S. vaccine safety enterprise. The program’s objective is to conduct research in vaccine safety related areas, specifically, but not limited to, determining the safety profile of new vaccines during the early development stage, developing or modifying existing vaccines to improve their safety, conducting applied research that will have a direct impact on the current vaccine safety monitoring system, conducting research that will achieve consensus definitions of vaccine safety outcomes that could be utilized to collect consensus data in clinical research conducted globally.NVPO is particularly interested in projects related to researching, establishing or testing the vaccine safety profile of vaccines that are currently recommended for or are expected to be routinely administered to pregnant women and/or newborns. Topics of research may cover establishing the safety of a vaccine in either the pregnant women, her newborn or both, at any stage of the vaccine development, testing and/or pre-clinical or clinical research and monitoring of vaccine safety. This pilot program encourages collaborative efforts with experts across fields to maximize the results and impact of the research project. NVPO scientific staff will have substantial programmatic involvement 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 accomplishment of the research by participating in the design of the activities, providing access to vaccine safety stakeholders and contributing with subject matter expertise • Oversee the adequacy of adverse event following immunization research, monitoring and result analysis and reporting, and have regular communications with the principal investigator (PI) and study team • Participate in the preparation of publications and public presentations of the data obtained under this Cooperative Agreement AUTHORITY: section 1702(a) of the Public Health Service Act, as amended [42 U.S.C. 300u-1(a)]

OASH/ National Vaccine Program Office (NVPO) provides strategic direction for the coordination of the vaccine and immunization enterprise through the National Vaccine Plan (NVP) implementation. NVPO specifically provides guidance and coordination for all vaccine safety systems, activities and research studies in the U.S. through the Immunization Safety Task Force (ISTF). While engaging vaccine safety stakeholders through the ISTF, NVPO is able to identify gaps in vaccine safety monitoring and research. NVPO has launched this pilot cooperative agreement program to partner with an organization to conduct research that will strengthen the current U.S. vaccine safety enterprise. The program’s objective is to conduct research in vaccine safety related areas, specifically, but not limited to, determining the safety profile of new vaccines during the early development stage, developing or modifying existing vaccines to improve their safety, conducting applied research that will have a direct impact on the current vaccine safety monitoring system, conducting research that will achieve consensus definitions of vaccine safety outcomes that could be utilized to collect consensus data in clinical research conducted globally. NVPO is particularly interested in projects related to researching, establishing or testing the vaccine safety profile of vaccines that are currently recommended for or are expected to be routinely administered to pregnant women and/or newborns. Topics of research may cover establishing the safety of a vaccine in either the pregnant women, her newborn or both, at any stage of the vaccine development, testing and/or pre-clinical or clinical research and monitoring of vaccine safety. This pilot program encourages collaborative efforts with experts across fields to maximize the results and impact of the research project. NVPO scientific staff will have substantial programmatic involvement 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 accomplishment of the research by participating in the design of the activities, providing access to vaccine safety stakeholders and contributing with subject matter expertise • Oversee the adequacy of adverse event following immunization research, monitoring and result analysis and reporting, and have regular communications with the principal investigator (PI) and study team • Participate in the preparation of publications and public presentations of the data obtained under this Cooperative Agreement AUTHORITY: section 1702(a) of the Public Health Service Act, as amended [42 U.S.C. 300u-1(a)]