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

Title

Date

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)

04/08/2021

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)

04/01/2021

COVID-19, Safety Outcomes

02/10/2021

COVID-19, Safety, Surveillance, Active, Monitoring

01/12/2021

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

08/2020

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

06/2020

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)

05/2020

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)

05/2020

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)

05/2020

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)

05/2020

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