Close collaboration among NIAID, the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (a component of the Department of Health and Human Services) was key to launching the trials quickly while ensuring high standards. Following initial discussions between the agencies on trial design, NIAID prepared the protocols and submitted them to the FDA for review. FDA rapidly completed the necessary reviews and approved the trial protocols.

Since 1962, NIAID's Vaccine and Treatment Evaluation Units (VTEUs) have been intensively involved in the successful development and clinical testing of vaccines and treatments against many pathogens that threaten the health of people in the United States and around the world. Among the vaccines tested have been those that prevent seasonal influenza, H5N1 avian influenza and pneumococcal pneumonia.

The VTEU network consists of eight university research hospitals and medical organizations across the United States that provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.

NIAID's Vaccine and Treatment Evaluation Units include the following:

Baylor College of Medicine, Houston Children's Hospital Medical Center, Cincinnati Emory University, Atlanta Group Health Cooperative, Seattle Saint Louis University, St. Louis University of Iowa, Iowa City University of Maryland School of Medicine, Baltimore Vanderbilt University, Nashville, Tenn.

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