FDA | Biologics Effectiveness and Safety (BEST)

Vaccines & Allergenics

The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases. CBER regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.

Most Recent Vaccines & Allergenics Assessments



Assessment of the Performance of COVID-19 Diagnosis Code Using SARS-CoV-2 Test Results Draft Protocol

Assessment-of-C19-Diagnosis-Code-Using-SARS-CoV-2-Test-Results-Study-Draft-Protocol (pdf)


COVID-19, Diagnosis Code, Test Results

Assessment of Risk of Safety Outcomes Following COVID-19 Vaccination Draft Master Protocol

COVID-19-Vaccine-Safety-Inferential-Draft-Master-Protocol (pdf)


COVID-19, Safety Outcomes


COVID-19, Safety, Surveillance, Active, Monitoring


COVID-19, Safety, Surveillance, Active, Monitoring, AESI, Background Rates


Rotavirus, Adherence, vaccines, infants, ACIP, RotaTeq, Rotarix, RotaTeq, Rotarix, immunization


Pregnancy Outcomes, Algorithm Validation, Gestational Age, Claims, EMR, Linked Database, ICD-10-CM, GAIA, Global Alignment of Immunization safety Assessment, Claims-based algorithm

Identifying Individuals with Diabetes Using Administrative Claims Data: A Code-Based Algorithm

Diabetes Algorithm Report 2020 (pdf)


Algorithm, Diabetes Mellitus, Administrative Claims Data, ICD-10-CM, ICD-9-CM, Exclusion Criterion, Covariate Iteration, Population Iteration, Outcome Iteration

Defining Acquired Hemolysis Using Administrative Claims Data: A Case Algorithm

Hemolysis Algorithm Report 2020 (pdf)


Algorithm, Hemolysis, Administrative Claims Data, intravenous immunoglobulins, IVIG, FAERS, FDA Adverse Event Reporting System, Outcome Definition, blood derived, blood derived products, acquired hemolysis, ICD-10-CM, ICD-9-CM

Defining Syncope Using Administrative Claims Data: A Case Algorithm

Syncope Algorithm Report 2020 (pdf)


Algorithm, Syncope, Administrative Claims Data, ICD-9-CM, ICD-10-CM

Defining Thromboembolic Events Using Administrative Claims Data: A Series of Case Algorithms

TEE Algorithm Report 2020 (pdf)


Algorithm, Thromboembolic event, pulmonary embolism, deep vein thrombosis, acute myocardial infarction, stroke, arterial embolism, thrombosis, TEE, ICD-9-CM, ICD-10-CM