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  1. CBER Biologics Effectiveness and Safety (BEST) System

Recall Alert

An update on the Cyclospora outbreak available here.

Publications & Presentations

Transparency is a fundamental principle of the operations of the CBER Surveillance Program including the BEST Initiative, Sentinel System, CMS collaboration, and others. Knowledge acquired from the surveillance activities is placed in the public domain. To accomplish this aim, information concerning surveillance activities will be made available on the BEST website and other locations when appropriate.

Most Recent Publications & Presentations Assessments

TitleDate
Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States2025/11/24
Safety monitoring of health outcomes following influenza vaccination during the 2023-2024 season among U.S. Commercially-insured individuals aged 6 months through 64 years: Self-controlled case series analyses2025/09/17
Safety Monitoring of Bivalent COVID-19 mRNA Vaccines Among Recipients 6 Months and Older in the United States2025/05/06
Effectiveness over time of a primary series of the original monovalent COVID-19 vaccines in adults in the United States2025/05/06
Safety monitoring of health outcomes following influenza vaccination during the 2023–2024 season among U.S. Medicare beneficiaries aged 65 years and older2025/04/19
Differences in influenza testing and treatment in micropolitan versus metropolitan areas in the U.S. using medicare claims data from 2010 to 20162025/01/23
Lessons Learned From Characterizing Long COVID Among US Medicare Beneficiaries2025/01/22
A Computable Phenotype Algorithm for Postvaccination Myocarditis/Pericarditis Detection Using Real-World Data: Validation Study2024/11/25
Relative Effectiveness and Waning of a Third Dose of mRNA COVID-19 Vaccine in Medicare Beneficiaries Aged 65 Years and Older during the BA.1/BA.2 Omicron Period2024/10/15
Stroke After Influenza Vaccines in Older Adults in the US, 2016 to 20192024/07/22
Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study2024/07/15
Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform2024/07/07
Assessment of potential adverse events following the 2022–2023 seasonal influenza vaccines among U.S. adults aged 65 years and older2024/05/03
Patterns of red blood cell utilization: Harnessing electronic health records data from the Information Standard for Blood and Transplant (ISBT) 128 system within the Biologics Effectiveness and Safety (BEST) initiative2024/04/30
Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study2024/04/26
Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years2024/04/24
Stroke Risk After COVID-19 Bivalent Vaccination Among US Older Adults2024/03/19
Real-world Effectiveness of mRNA COVID-19 Vaccines Among US Nursing Home Residents Aged ≥65 Years in the Pre-Delta and High Delta Periods2024/01/29
CBER BEST IM Exchange Pilot - Biologics Effectiveness and Safety Innovative Methods2023/11/14
Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure2023/10/14-17
Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure: Pilot2023/09/12
Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.2023/07/19
Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination2023/06/23
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis2023/06/07
Safety of the BNT162b2 COVID-19 Vaccine in Children Aged 5 to 17 Years2023/05/22
Use of Immunization Information Systems in Ascertainment of COVID-19 Vaccinations for Claims-Based Vaccine Safety and Effectiveness Studies2023/05/16
Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis2023/03/03
Characterization of COVID-19 Hospitalized Patients in Three United States Electronic Health Record Databases2023/03/01
Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion2023/02/24
Immune globulin usage trends in commercially insured and Medicare populations, 2009-20192023/02/20
Comparison of adverse pregnancy and birth outcomes using archival medical records before and during the first wave of the COVID-19 pandemic in Kinshasa, Democratic Republic of Congo: a facility-based, retrospective cohort study2023/01/16
Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older2023/01/09
Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-20202022/11/08
Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years2022/10/26
Detection of allergic transfusion-related adverse events from electronic medical records2022/10
A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and Feasibility Study2022/09/14

Active Surveillance of Vaccine Safety: Intermediate/Advanced Topics in Vaccine Epidemiology (ICPE 2022), Hui Lee Wong, PhD

2022/08/25
Assessment of performance characteristics of COVID-19 ICD-10-CM diagnosis code U07.1 using SARS-CoV-2 nucleic acid amplification test results2022/08/18
Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-192022/08/18
Operational lessons learned in conducting an international study on pharmacovigilance in pregnancy in resource-constrained settings: The WHO Global Vaccine safety Multi-Country collaboration project2022/08
Adherence to face mask use during the COVID-19 pandemic among women seeking antenatal care in Kinshasa, Democratic Republic of Congo: a facility-based cross-sectional study2022/07/08
Setting The World on FHIR2022/07
Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases, February-November 20202022/06/18
Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases2022/06/11
Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16-29 years2022/04/26
Risk Factors for COVID-19 Deaths Among Elderly Nursing Home Medicare Beneficiaries in the Prevaccine Period2022/02/15
The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing2021/12/22
Risk of Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries2021/12/01
Vaccine exposure during pregnancy among privately and publicly insured women in the United States, 2016–20182021/10/01
Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database2021/09/30
Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review2021/09/24
Acute myocardial infarction: Development and application of an ICD-10-CM-based algorithm to a large U.S. healthcare claims-based database
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253580		2021/07/01
U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines2021/06/23
CBER BEST: Leveraging AI to Build an Automated Adverse Events Reporting System
Presentation begins at the 2:12:00 mark		2021/05/26
Natural History of Coronavirus Disease 2019: Risk Factors for Hospitalizations and Deaths Among >26 Million US Medicare Beneficiaries2021/03/29
Development of an Application That Semi-Automates Clinician Verification and Reporting of Transfusion Allergic Reaction Cases2020/10/03-05
Development of a SMART-on-FHIR-enabled Semi-Automated Adverse Event Validation and Reporting Application2020/06
An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for Biologics2020/01/29
Biologics Effectiveness and Safety (BEST) Initiative: Sentinel Public Meeting 20192019/04/03
Biologics Effectiveness and Safety (BEST) Initiative: First Year2018/10/12
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