FDA Center for Biologics Evaluation and Research (CBER) awarded a cooperative agreement grant in the amount of $1,035,000 to the World Health Organization (WHO) on September 14, 2011, and an additional $1,058,500 in Year 2 through Year 4 of the grant. 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 work supported by the cooperative agreement includes NRA assessments, training programs for regulators, an international proficiency study which aims to assess the performance of National Control Laboratories and manufacturers in the single radial immune diffusion (SRID) test, development of WHO Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines, and other regulatory capacity building activities. This award further advances CBER’s ongoing support as a WHO Collaborating Center for Biological Standardization, and advances FDA’s goal of strengthening regulatory systems – a goal that is critical for ensuring access to safe and effective vaccines worldwide.