Clinical Immunization Safety Assessment 2023 - 2028 (CISA)

The Clinical Immunization Safety Assessment 2023-2028 Master IDIQ is a $86,008,000.12 multiple-award contract vehicle established by the Centers for Disease Control and Prevention (CDC) to provide an "as needed" mechanism for obtaining vaccine safety services through individual task orders. The contract requires awardees to be medical research centers that provide clinical care to patients and can recruit participants for clinical research studies. The primary scope encompasses two main categories of work: clinical case reviews and evaluation of vaccine safety issues with coordination activities, and research studies to advance knowledge of vaccine safety and inform clinical and public health practices. Contractors furnish all necessary labor, supervision, equipment, materials, supplies, and travel to support these public health, scientific, and technical services. The vehicle serves three principal goals: functioning as a vaccine safety resource for U.S. healthcare providers with complex vaccine safety questions about specific patients, assisting the CDC and its partners in evaluating emerging vaccine safety issues, and conducting clinical research studies to better understand vaccine safety and identify preventive strategies for adverse events following immunization.

Recent delivery orders under this Master IDIQ demonstrate significant activity in vaccine safety research, with task order values ranging from approximately $239,000 to $6,648,584 and completion dates extending through September 2028. Notable recent task orders include a multi-site Clinical Immunization Safety Assessment RSV Infants Study with lead sites at Duke University ($1,541,816) and Children's Hospital Medical Center ($716,608), along with contributing sites at Kaiser Permanente ($741,949), Emory University ($781,591), and Columbia University ($774,425), all with performance periods through September 2027. Established academic medical research centers dominate as prime contractors, including Vanderbilt University Medical Center ($6,648,584), Duke University ($2,180,450), Boston Medical Center ($1,091,528), and Emory University ($1,000,610), with most delivering services on a cost-no-fee basis. All task orders identified carry no set-aside designations, indicating open competition, and are primarily performed at the contractors' institutional locations across the United States, with funding provided entirely by the CDC.