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CBER-WHO Cooperative Agreement: Pharmacovigilance Capacity Building

FDA Center for Biologics Evaluation and Research (CBER) awarded a cooperative agreement grant in the amount of $780,000 to the World Health Organization (WHO) on September 5, 2012, and an additional $462,900 in Years 2 and 3 of the grant.  The project represents collaborative efforts between FDA/CBER and the WHO to support scientific collaboration in pharmacovigilance to advance global access to safe and effective vaccines.

Immunization of children, adolescents, and adults is highly effective for preventing infectious diseases, and is a core component of many national and international programs to improve public health and respond to pandemic influenza and other emerging infectious diseases.  In the last ten years, there has been considerable progress in developing new vaccines and expanding use of existing and new vaccines globally. With advancements in scientific knowledge and technology, the complexity of vaccines has increased and more diseases are being targeted for prevention through vaccination than ever before. The expanded use of vaccines can have significant public health benefits, but the success of immunization programs is only possible in the context of a strong safety record for those vaccines.

Establishment of a robust pharmacovigilance system is an important regulatory tool for ensuring that vaccines are safe and effective.  It is essential to continue monitoring vaccine safety throughout the product life cycle, and to obtain and analyze any additional safety information in “real time” as the product is used in greater numbers of people and in diverse populations.

This cooperative agreement supports global collaborative efforts to advance pharmacovigilance systems using a range of approaches.  Objectives include improving approaches for vaccine safety studies in low and middle income countries (LMICs), and evaluating mechanisms such as use of social media and mobile communication devices for gathering vaccine safety information following immunization.

The work supported by the cooperative agreement includes development of a network of hospital-based sentinel sites in LMICs to allow for hypothesis testing along the model proposed by the global Guillain-Barre Syndrome (GBS) study [a pilot study led by CBER scientists and conducted in collaboration with WHO; Izurieta et al, Vaccine 2013 Aug 2;31(35):3623-7].  Additionally, the cooperative agreement has supported a training program by the Uppsala Monitoring Center in “Application of Pharmacovigilance to Regulatory Decisions for Vaccines”. 

This cooperative agreement grant further supports our scientific collaborations with WHO to enhance utilization of a range of pharmacovigilance tools as a means to further vaccine safety and potentially facilitate introduction of new vaccines more quickly.  These efforts are central to strengthening immunization programs worldwide, enhancing global preparedness to respond to pandemic influenza and other emerging infectious diseases, and building public confidence in vaccine safety.

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