Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research

For over 60 years, the National Institutes of Health (NIH)-funded Vaccine and Treatment Evaluation Units (VTEUs) have led national efforts in vaccine development, evaluation of novel treatment of infectious diseases, and pandemic preparedness. Although most VTEU research has been conducted in healthy adult volunteers, the VTEU is composed of specialized clinician-scientists in pediatrics, maternal fetal medicine, and specialties that care for immunocompromised hosts. Here we summarize the role of the VTEU in the investigation of the safety and efficacy of vaccines and therapeutics in vulnerable populations, including children, pregnant women, the elderly, and immunocompromised individuals.