FDA | Biologics Effectiveness and Safety (BEST)

The Biologics Effectiveness and Safety (BEST) Initiative is part of the Center for Biologics Evaluation and Research (CBER) surveillance program that aims to fulfill the requirements for the FDA Amendments Act of 2007. BEST is part of the Sentinel Initiative housed within the Office of Biostatistics and Pharmacovigilance (OBPV) and contributes to CBER’s mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, human tissues and cellular products, gene therapies, allergenics, xenotransplantation products and devices related to biologics.

About

Data & Surveillance Activities

Communication & Outreach

Announcements

FDA BEST is offering an opportunity for an Epidemiologist. If you are interested, see the flyer.

The CBER BEST Initiative Seminar Series will have Dr. Yong Chen on April 17, 2024, 11:00-12:00 PM ET. Dr. Chen will discuss “Real-World Effectiveness of BNT162b2 Against Infection and Severe Diseases in Children and Adolescents: causal inference under misclassification in treatment status,” see our flyer. Anyone can join for free.

The Assessment of Effectiveness of BNT162b2 COVID-19 Vaccination in Children Aged 5 to 17 Years in the United States report is available for review.

The Master Protocol: Evaluation of Nine Safety Outcomes following 2023-2024 Influenza Vaccination in Persons 6 Months and Older protocol is available for review.

The Evaluation of Multiple Safety Outcomes following 2023-2024 COVID-19 Vaccination in Persons 6 Months and Older protocol is available for review.

The Evaluation of Multiple Safety Outcomes following Respiratory Syncytial Virus (RSV) Vaccination in Adults 60 Years and Older protocol is available for review.

Features

See Publications & Presentations for recent BEST publications.

For more information on BEST Artificial Intelligence and Natural Language Processing, see the new BEST Innovative Methods Exchange Platform and FDA’s Survey of Health and Patient Experience (SHAPE) Platform.

Final outcome reports are available for review.

For more information on our distributed network of data sources, see BEST Data Sources.