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 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
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
COVID-19 Vaccine Safety Surveillance: Active Monitoring Master Protocol
02/10/2021
COVID-19, Safety, Surveillance, Active, Monitoring
Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring
C19-Vaccine-Safety-AESI-Background-Rate-Protocol-FINAL-2020 (pdf)
01/12/2021
COVID-19, Safety, Surveillance, Active, Monitoring, AESI, Background Rates
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
