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
Using Double Negative Control Method to Adjust for Unmeasured Confounding When Evaluating Vaccine Effectiveness Among Medicare Older Adults (PDUFA VII Methodology Development Project)	2025/11/20
Evaluating the Risk of Adverse Events After COVID-19 Diagnosis	2024/12/13
Assessment of Effectiveness of Booster/Additional Doses of COVID-19 Vaccines in the United States	2024/10/10
Assessment of Effectiveness of a Primary Series of Monovalent COVID-19 Vaccination in Adults in the United States	2024/08/08
Protocol Addendum: Validation of Algorithms to Identify Multisystem Inflammatory Syndrome in Children (MIS-C) in Administrative Claims Data	2024/07/12
Assessment of Effectiveness of BNT162b2 COVID-19 Vaccination in Children Aged 5 to 17 Years in the United States	2024/03/19
Master Protocol: Evaluation of Nine Safety Outcomes following 2023-2024 Influenza Vaccination in Persons 6 Months and Older	2024/02/27
Evaluation of Multiple Safety Outcomes following 2023-2024 COVID-19 Vaccination in Persons 6 Months and Older	2023/12/22
Evaluation of Multiple Safety Outcomes following Respiratory Syncytial Virus (RSV) Vaccination in Adults 60 Years and Older	2023/12/22
FDA Evaluation of a Preliminary Seizure Safety Signal from Rapid Surveillance of Children Ages 2 – 4/5 yrs. following COVID-19 mRNA Vaccination	2023/07/23
Master Protocol: Assessment of the Risk of Adverse Events Following Influenza Vaccinations Approved during the 2022-2023 Influenza Season	2023/06/22
Safety Surveillance of Vaccines Used for Mpox Prevention: Active Monitoring Master Protocol	2023/06/19
COVID-19 Vaccine Safety Surveillance: Active Monitoring Master Protocol	2023/03/09
Assessment of Stroke Following COVID-19 mRNA, Bivalent Booster Vaccination	2023/02/27
Evaluating the Risk of Adverse Events After COVID-19 Diagnosis	2023/02/10
Risk of Adverse Events of Special Interest Post COVID-19 Vaccines: A Real-World Study Across University of California Health System	2023/01/21
Safety Assessment of 3rd Dose/Booster of COVID-19 mRNA Vaccines	2022/08/31
Assessment of Effectiveness of COVID-19 Vaccination in the United States Protocol	2022/08/18
Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring	2022/07/28
Supplementing Administrative Claims COVID-19 Vaccine Data with Immunization Information Systems (IIS) Data: A Feasibility Study Report	2022/07/26
BETTER: Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance)	2022/07/22
Characterization of Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) in Electronic Health Records	2022/03/15
COVID-19 Vaccine Safety Surveillance Project: Comparative Risk of Myocarditis or Pericarditis following COVID-19 mRNA Vaccination	2021/12/10
Assessment of Acute Myocardial Infarction, Pulmonary Embolism, Disseminated Intravascular Coagulation and Immune Thrombocytopenia Following COVID-19 Vaccination Protocol	2021/07/30
Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases	2021/07/22
Assessment of Risk of Safety Outcomes Following COVID-19 Vaccination Draft Master Protocol	2021/05/28
Assessment of the Performance of COVID-19 Diagnosis Code Using SARS-CoV-2 Test Results Draft Protocol	2021/04/08
Adherence to Administration Schedules of U.S.-Licensed Rotavirus Vaccines for Infants, 2014-2018	2020/08
Final Report: Validating Pregnancy Outcomes and Gestational Age in Claims-EMR Linked Database	2020/06
Study Protocol: Validating Pregnancy Outcomes and Gestational Age in a Claims-EMR Linked Database	2020/06