Vaccines, Blood, & Biologics Studies

CBER regulates biologic products. This ensures their safety and efficacy. These products include:

• blood and blood products
• vaccines
• cellular, tissue, and gene therapies

Postlicensure Rapid Immunization Safety Monitoring (PRISM)

PRISM is a subcomponent of the Sentinel System focusing on vaccine safety surveillance. PRISM is for refinement and evaluation of potential safety signals. These potential safety signals include those identified during premarket and postmarket reviews.

Blood Safety Continuous Active Surveillance Network (BloodSCAN)

BloodSCAN is a subcomponent of the Sentinel System. It focuses on blood and blood product safety surveillance. BloodSCAN assesses the safety of different blood products. This is for both the premarket and postmarket settings.

The Sentinel System enables CBER to proactively assess biologics safety under real-world conditions. This reflects patient care in the United States. This capability enhances safety monitoring. It also allows CBER to systematically evaluate safety signals identified during premarket trials. CBER also evaluates safety signals that emerge after products reach the market. 

Sentinel assessments use automated surveillance tools. These same tools support FDA’s Active Risk Identification & Analysis System. This approach improves the efficiency of FDA monitoring. It also ensures patient privacy through the use of the Sentinel Distributed Database. 

CBER uses results to evaluate safety signals. Sentinel studies complement existing surveillance systems. Existing surveillance systems include the Vaccine Adverse Event Reporting System (VAERS). CBER reviews the results from different surveillance sources. CBER considers the strengths and limitations of each data source. In doing this, they can make the most informed regulatory decisions possible.

CBER Biologics Effectiveness & Safety (BEST) System

BEST is part of the Sentinel Initiative and it promotes CBER's Office of Biostatistics and Epidemiology's (OBE) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues, and advanced therapeutics.

The Biologics Effectiveness and Safety (BEST) System was launched in October 2017 to expand and enhance CBER access to new and better data sources, methods, tools, expertise, and infrastructure to conduct surveillance and epidemiologic studies.