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
Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring
C19-Vax-Safety-AESI-Bkgd-Rate-Protocol-FINAL-2020 (pdf)
- C19-Vax-Safety-AESI-Bkgd-Rate-Protocol-Addendum-2021 (pdf)
- C19-Vax-Safety-AESI-Bkgd-Rate-Est-Protocol-Suppl (xlsx)
- C19-Vax-Safety-AESI-Bkgd-Rate-Final-Report-2021 (pdf)
- C19-Vax-Safety-AESI-Bkgd-Rate-Final-Report-Tbls-Figs-2021 (xlsx)
- C19-Vaccine-AESI-BKGD-Rates-Report-CVS-Addendum-2022 (pdf)
- C19-Vaccine-AESI-BKGD-Rate-Report-Tables-Figures-2022 (xlsx)
- Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring-All Files (zip)
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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
07/26/2022
Immunization, Information, Systems, Administrative, Claims
BETTER: Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance)
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)
- C-19-Vaccine-Safety-Protocol-Supplemental-2021 (xlsx)
- C19-Active-Monitoring-Protocol-Addendum-2022 (pdf)
- C19-Booster-Active-Monitoring-Protocol-Addendum-2022 (pdf)
- C19-Vaccine-Safety-Protocol-2021-All Files (zip)
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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
Characterization of Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) in Electronic Health Records
- Concomitant-Medication-Codelist-Report-Supplement (xlsx)
- LOIN C-Labs-Vitals-Codelist-Report-Supplement (xlsx)
- Symptom Comorbidity Codelist Report Supplement (xlsx)
- Characterization of Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) in Electronic Health Records All Files (zip)
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03/15/2022
COVID-19, Electronic Health Records, Hospitalized, Patients
Assessment of Effectiveness of COVID-19 Vaccination in the United States protocol
03/03/2022
COVID-19, Vaccine, Effectiveness, Comparative, Analysis
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
Adherence to Administration Schedules of U.S.-Licensed Rotavirus Vaccines for Infants, 2014-2018
Adherence Rotavirus Vaccines Infants Specifications 2020 (pdf)
08/2020
Rotavirus, Adherence, vaccines, infants, ACIP, RotaTeq, Rotarix, RotaTeq, Rotarix, immunization
Final Report: Validating Pregnancy Outcomes and Gestational Age in Claims-EMR Linked Database
Validating Pregnancy Outcomes Linked Database Report 2020 (pdf)
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
Study Protocol: Validating Pregnancy Outcomes and Gestational Age in a Claims-EMR Linked Database
Validating Pregnancy Outcomes Linked Database Protocol 2020 (pdf)
- Validating Pregnancy Outcomes Linked Database D1 Protocol 2020 (xlsx)
- Validating Pregnancy Outcomes Linked Database D2 Protocol 2020 (xlsx)
- Validating Pregnancy Outcomes Linked Database D3 Protocol 2020 (xlsx)
- Validating Pregnancy Outcomes Linked Database D4 Protocol 2020 (xlsx)
- Validating Pregnancy Outcomes Linked Database D5 Protocol 2020 (xlsx)
- Validating Pregnancy Outcomes Linked Database Protocol 2020 All Files (zip)
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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
