Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)

The U.S. FDAs Center for Biologics Evaluation and Research (FDA/CBER) has been a leader and active participant in the global community to improve human health in the worlds populations over many years. Its international engagements have historically been, and continue to be, framed by a simple truth: protection of global public health against infectious disease threats translates into protection of U.S. public health. FDA, through CBER, has longstanding collaborations with the WHO in the area of vaccines and biologics. For example, the FDA/CBER has been a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization since 1998. The purpose, scope and areas of activity for each term are captured in a set of Terms of Reference (TOR) mutually agreed to by FDA/CBER and WHO and are reflective of their shared interest in supporting the quality, safety and standards work of both organizations. An important additional area is the FDA/CBER's engagement with the WHO Vaccine Prequalification Program. The WHO, through the QSS/IVB, provides advice to the United Nations Children's Fund (UNICEF) and other United Nations (UN) agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs they administer. An important part of the Vaccine Prequalification Program is WHO's reliance upon the national regulatory authority (NRA) of the country of manufacture of the vaccine if the NRA meets the WHO indicators that qualify it as a functional NRA. In 2009, FDA entered into a arrangement with WHO/QSS to enable FDA/CBER to serve as a reference NRA under this prequalification program, and the Center is currently a reference NRA for eight U.S. licensed vaccines including five influenza vaccines.