Integrating Safety and Efficacy Evaluation Throughout Vaccine Research and Development

Vaccines have led to some of the greatest public health achievements in history, including the worldwide eradication of naturally occurring smallpox and the near eradication of polio. In addition, vaccines have contributed to significant reduction in the disease burden imposed by measles, mumps, hepatitis, influenza, diphtheria, and many other infections. The science of vaccinology is dynamic; it unfolds as technology enables scientists to continue to create safer and more effective vaccines. Safety evaluation is integrated into every step of the vaccine research and development process. The National Institute of Allergy and Infectious Diseases (NIAID) is the lead institute at the National Institutes of Health (NIH) for research and development of vaccines against emerging and reemerging infectious diseases (Text Box 1). Together with partners throughout the federal government, in academia, and in the public and private sectors, NIAID-supported scientists have helped develop many important life-saving vaccines against diseases such as invasive Haemophilus influenzae type b (Hib), pneumococcal pneumonia, meningitis, pertussis, influenza, chickenpox, and hepatitis A and B. Use of these and other vaccines worldwide has made significant contributions to public health by reducing the morbidity and mortality associated with many dreaded infectious diseases (Text Box 2). Discovery, development, and evaluation of vaccines are performed in multiple stages as promising ideas are developed into potential vaccine candidates. Developing a vaccine usually involves collaboration between federal agencies, academia, and industry. The NIAID's role in vaccine development and testing extends from basic research through clinical evaluation (Fig 1). FIGURE 1 Stages of vaccine research, development, and evaluation. Safety evaluation is integral to every stage of the product-development pathway. This pathway begins with basic research, which involves understanding the pathogen's mechanism of action, the interaction between pathogen and host, and the host response. Target identification entails studying the biological plausibility of particular strategies for creating … Address correspondence to Richard L. Gorman, MD, Associate Director for Clinical Research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, 6610 Rockledge Dr, MSC 6604, Bethesda, MD 20892-6604. E-mail: gormanr{at}niaid.nih.gov