“As the Food and Drug Administration prepares for COVID-19 vaccine authorizations and approvals as a result of the Department of Health and Human Services’ Operation Warp Speed clinical trials, the agency is also focused on strengthening surveillance efforts on the vaccine’s long-term safety.”
“During FDA’s Vaccines and Related Biological Products Advisory Committee meeting last week, the agency’s Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) Director Steven Anderson outlined the agency’s plans to monitor COVID-19 vaccine safety and effectiveness in this later phase.”
“’FDA’s approach for safety is really a ‘safety throughout the lifecycle’ approach for vaccines and regulated products, and that includes pre-licensure as well as post-licensure space,’ the agency’s Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) Director Steven Anderson said during a Vaccines and Related Biological Products Advisory Committee meeting last week.”
“Anderson noted two types of post-licensure programs for continuous safety surveillance monitoring: active and passive…”
“FDA’s active risk identification and analysis data systems for monitoring vaccines and other medical products were created as directed by the FDA Amendments Act of 2007 and with funding from the Prescription Drug User Fee Act VI of 2017, Anderson said.”
“One of these systems is Sentinel, for example. Part of Sentinel is the Biologics Effectiveness and Safety System (BEST).”
“Unlike passive programs, active surveillance programs can collect adverse event data using automation, such as natural language processing and machine learning. The BEST system collects real-world data from electronic claims data sources — including the claims data of approximately 55 million elderly people ages 65 years and older enrolled in the Centers for Medicare and Medicaid Services…” Read the full article here.
Source: Ensuring Safety of a COVID-19 Vaccine via Technology – By Faith Ryan, October 27, 2020. GovernmentCIO.
