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

Safety Assessment of 3rd Dose/Booster of COVID-19 mRNA Vaccines

C19-Post-Booster-Dose-AESI-Risk-Protocol-2022 (pdf)

08/31/2022

booster dose, 3rd dose, safety assessment, covid-19 mrna

Assessment of Effectiveness of COVID-19 Vaccination in the United States Protocol

C19-VX-Effectiveness-Protocol 2022 508 (pdf)

The Assessment of Effectiveness of COVID-19 Vaccination in the United States Protocol was finalized 3/3/2022. An addendum for this protocol for the pediatric population was added 8/18/2022.

08/18/2022

COVID-19, Vaccine, Effectiveness, Comparative, Analysis

Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring

C19-Vax-Safety-AESI-Bkgd-Rate-Protocol-FINAL-2020 (pdf)

The “Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring” Protocol was finalized 1/12/21. An addendum and final report for this protocol were added December 2021. An addendum for CVS Health Database Results was added to this protocol on 7/28/22.

07/28/2022

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

Supplementing Administrative Claims COVID-19 Vaccine Data with Immunization Information Systems (IIS) Data: A Feasibility Study Report

IIS-Feasibility-Optum-Study-Report-2022 (pdf)

07/26/2022

Immunization, Information, Systems, Administrative, Claims

BETTER: Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance)

BEST BETTER Protocol 2022 (pdf)

07/22/2022

Bayesian, Vaccines, Surveillance, Time-to-event, Reliability, Research Protocol

COVID-19 Vaccine Safety Surveillance: Active Monitoring Master Protocol

C19-Vaccine-Safety-Protocol-2021 (pdf)

The COVID-19 Vaccine Safety Surveillance: Active Monitoring Master Protocol was finalized 2/10/2021. An addendum for this protocol for the pediatric population was added 4/12/2022. An addendum for this protocol for following third or booster dose administration among a commercially insured population aged 18-64 years and the Medicare population aged 65 years and older was added 5/27/2022.

05/27/2022

COVID-19, Safety, Surveillance, Active, Monitoring

COVID-19 Vaccine Safety Surveillance Project: Comparative Risk of Myocarditis or Pericarditis following COVID-19 mRNA Vaccination

C-19-MyoPericarditis-mRNA-Comparative-Safety-Protocol-2021 (pdf)

12/10/2021

COVID-19, Safety, Surveillance, Active, Monitoring, Myocarditis, Pericarditis

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.

07/30/2021

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

Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases

C-19-Characterization-of-Test-Positivity-Rates-in-EHRs-Final-Report-2021 (pdf)

07/22/2021

COVID-19, Diagnosis Code, Test Results

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

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

05/28/2021

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)

04/08/2021

COVID-19, Diagnosis Code, Test Results

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