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 Acute Myocardial Infarction, Pulmonary Embolism, Disseminated Intravascular Coagulation and Immune Thrombocytopenia Following COVID-19 Vaccination Protocol

C-19-Vaccine-Safety-AMI-PE-DIC-ITP-Protocol-2021 (pdf)

A public communication for this protocol is available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/initial-results-near-real-time-safety-monitoring-covid-19-vaccines-persons-aged-65-years-and-older.


COVID-19, Acute Myocardial Infarction, Pulmonary Embolism, Disseminated Intravascular Coagulation, Immune Thrombocytopenia

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

COVID-19-Vaccine-Safety-Inferential-Master-Protocol-Final-2021 (pdf)


COVID-19, Safety Outcomes

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


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