Clinical Immunization Safety Assessment (CISA)

The Clinical Immunization Safety Assessment (CISA) is a master indefinite delivery/indefinite quantity (IDIQ) contract awarded by the Centers for Disease Control and Prevention (CDC) to multiple prime contractors for conducting comprehensive vaccine safety research and clinical assessments. The contract's primary objectives include clinical case reviews, evaluation of vaccine safety issues, and research studies designed to advance knowledge about vaccine safety and inform clinical and public health practices. With a shared ceiling of $50 million and an award date of September 24, 2012, the contract supports critical immunization safety monitoring and research across various vaccine types and population segments.

The task orders under this IDIQ primarily focus on COVID-19 related pediatric and adult vaccine safety studies, with additional research on vaccines like Shingrix and influenza. Typical task orders range from $100,000 to $2.1 million, with performance periods spanning 1-3 years. Prime contractors consistently include academic medical centers and research institutions such as Duke University, Vanderbilt University, Children's Hospital Medical Center, Johns Hopkins University, Columbia University, Kaiser Foundation Hospitals, and Boston Medical Center. These task orders are consistently cost no fee and have no set-aside designations, reflecting the specialized nature of the research. Performance locations are predominantly in major academic and medical research hubs including Durham (NC), Cincinnati (OH), Nashville (TN), Baltimore (MD), New York City, Oakland (CA), and Boston (MA). The contract supports the CDC's critical mission of monitoring vaccine safety across various demographic groups and emerging public health challenges.