FDA Center for Biologics Evaluation and Research (CBER) has awarded a cooperative agreement grant in the amount of $1,035,000 to the World Health Organization (WHO) on September 14, 2011. The project represents collaborative efforts between FDA and the WHO to support scientific collaboration and enhance regulatory capabilities of National Regulatory Authorities (NRAs) to advance global access to safe and effective vaccines and other biologicals that meet international standards. This project will further enhance technical cooperation between FDA, WHO, and its Member States.

The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

 

FDA CBER is a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization. CBER is also engaged with the WHO Vaccine Prequalification Program. CBER has worked with WHO in the global community to improve human public health worldwide for many years. A core principle of CBER’s international engagements to protect global public health is the fact that efforts to address infectious disease threats anywhere in the world translates to protection of the U.S. population, which benefits U.S. public health overall.

 

The award will help secure high level influenza vaccine regulation for grantee countries through achieving/maintaining NRA functionality both for seasonal and pandemic vaccines. Ultimately, the effort is to bolster resources to strengthen regulatory oversight for influenza vaccine production and thus, maximize the returns on total investments with high quality, effective influenza vaccines that can be deployed worldwide quickly and equitably in future pandemics. In doing so, it is anticipated that strengthening regulatory capacity will benefit the broader arena of access to and supply of vaccines globally.  Additional project goals include development of a WHO guideline document for vaccine manufacturers and regulators on non-clinical evaluation of adjuvanted vaccines. 

 

One of CBER's six primary strategic goals in 2011 is to improve global public health through international collaboration, including promoting research and information sharing.  The U.S. FDA generally, and more specifically the FDA/CBER, has long-standing productive collaborations with the WHO in the area of vaccines and other biologics.  This cooperative agreement grant further supports our scientific collaborations with WHO to enhance regulatory capabilities of NRAs worldwide.