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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CBER-WHO Cooperative Agreement: Innovations in Vaccine Clinical Trials and Pharmacovigilance

FDA Center for Biologics Evaluation and Research (CBER) has awarded a cooperative agreement grant in the amount of $780,000 to the World Health Organization (WHO) on September 5, 2012. The project represents collaborative efforts between FDA and the WHO to support innovation in vaccine clinical trial design and 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.

Clinical trials are performed to evaluate the safety and efficacy of vaccines.  Improving the efficiency of vaccine clinical trials in the development process could lead to more rapid introduction of new vaccines.  There is increased interest in finding innovative study designs that optimize allocation of study participants between late phase clinical trials and post-marketing safety studies, changes that could lead to more rapid access to lifesaving vaccines while still obtaining the data necessary to ensure vaccine safety before universal use. However, any such potential improvements in the efficiency of vaccine clinical trials are contingent upon effective pharmacovigilance.

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, and evaluating mechanisms such as use of social media and mobile communication devices for gathering public health information from low and middle income countries.

This cooperative agreement grant further supports our scientific collaborations with WHO to advance innovative approaches to vaccine clinical trial design, and 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.