The National Institute of Allergy and Infectious Diseases (NIAID) established the Vaccine and Treatment Evaluation Units (VTEUs) in 1962. They provide a ready resource for conducting clinical trials of vaccines and treatments for infectious diseases.
VTEUs have played a key role in the NIAID effort to develop new and improved vaccines and therapies against infectious diseases for over four decades. They have conducted hundreds of clinical trials, many of which have contributed to vaccine licensure.
An important strength of the VTEUs is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a safe, effective and quick manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. For example, the United States experienced an unexpected, significant shortage of seasonal influenza vaccines in 2004. The VTEUs swiftly initiated a large-scale trial to evaluate the seasonal influenza vaccine Fluarix for use in healthy adults in the United States. The trial demonstrated the vaccine’s safety and ability to generate an immune response and ultimately led to its expedited approval by the Food and Drug Administration (FDA) in August 2005—less than a year after the trial began. The VTEUs conducted multiple studies in 2005 and 2006 of a vaccine for a strain of H5N1 avian influenza virus to determine the most effective dose. Those studies led to the licensure of the first vaccine approved by FDA against an H5N1 influenza virus. Now in 2020 will be conducting studies of vaccines for SARS-CoV-2 for the prevention of disease due to the novel coronavirus.