FDA | Biologics Effectiveness and Safety (BEST)

Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States

PLoS One. 2025 Nov 24 (website)

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 analyses

Vaccine. 2025 Sep 17 (website)

Safety Monitoring of Bivalent COVID-19 mRNA Vaccines Among Recipients 6 Months and Older in the United States

Pharmacoepidemiol Drug Saf. 2025 May 6 (website)

Effectiveness over time of a primary series of the original monovalent COVID-19 vaccines in adults in the United States

PLoS One. 2025 May 6 (website)

Safety monitoring of health outcomes following influenza vaccination during the 2023–2024 season among U.S. Medicare beneficiaries aged 65 years and older

Vaccine. 2025 Apr 19 (website)

Differences in influenza testing and treatment in micropolitan versus metropolitan areas in the U.S. using medicare claims data from 2010 to 2016

BMC Public Health. 2025 Jan 23 (website)

Lessons Learned From Characterizing Long COVID Among US Medicare Beneficiaries

Pharmacoepidemiol Drug Saf. 2025 Jan 22 (website)

A Computable Phenotype Algorithm for Postvaccination Myocarditis/Pericarditis Detection Using Real-World Data: Validation Study

J Med Internet Res. 2024 Nov 25 (website)

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 Period

The Journal of Infectious Diseases. 2024 Oct 15 (website)

Stroke After Influenza Vaccines in Older Adults in the US, 2016 to 2019

JAMA Network Open. 2024 Jul 22 (website)

Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study

JMIR Public Health Surveill. 2024 Jul 15 (website)

Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform

Frontiers in Public Health. 2024 Jul 07 (website)

Assessment of potential adverse events following the 2022–2023 seasonal influenza vaccines among U.S. adults aged 65 years and older

Vaccine. 2024 May 03 (website)

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) initiative

Transfusion. 2024 Apr 30 (website)

Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study

BMC Pediatrics. 2024 Apr 26 (website)

Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years

JAMA Network Open. 2024 Apr 24 (website)

Stroke Risk After COVID-19 Bivalent Vaccination Among US Older Adults

JAMA. 2024 Mar 19 (website)

Real-world Effectiveness of mRNA COVID-19 Vaccines Among US Nursing Home Residents Aged ≥65 Years in the Pre-Delta and High Delta Periods

Open Forum Infectious Diseases. 2024 Jan 29 (website)

CBER BEST IM Exchange Pilot - Biologics Effectiveness and Safety Innovative Methods

eHealth Exchange Annual Meeting Presentation. 2023 Nov 14 (pdf)

Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure

AABB Annual Meeting Presentation. 2023 Oct 14-17 (pdf)

Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure: Pilot

11th Annual Scientific Computing Days Presentation. 2023 Sep 12 (pdf)

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.

Vaccine. 2023 Jul 19 (website)

Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination

Vaccine. 2023 Jun 23 (website)

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

Vaccine. 2023 Jun 07 (website)

Safety of the BNT162b2 COVID-19 Vaccine in Children Aged 5 to 17 Years

Jama Pediatrics. 2023 May 22 (website)

Use of Immunization Information Systems in Ascertainment of COVID-19 Vaccinations for Claims-Based Vaccine Safety and Effectiveness Studies

JAMA Network Open. 2023 May 16 (website)

Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis

Medicine (Baltimore). 2023 Mar 03 (website)

Characterization of COVID-19 Hospitalized Patients in Three United States Electronic Health Record Databases

Pathogens. 2023 Mar 01 (website)

Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion

Drug Saf. 2023 Feb 24 (website)

Immune globulin usage trends in commercially insured and Medicare populations, 2009-2019

Transfusion. 2023 Feb 20 (website)

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 study

BMC Pregnancy Childbirth. 2023 Jan 16 (website)

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

Vaccine. 2023 Jan 09 (website)

Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020

Vaccine. 2022 Nov 08 (website)

Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years

Vaccine. 2022 Oct 26 (website)

Detection of allergic transfusion-related adverse events from electronic medical records

Transfusion. 2022 Oct (website)

A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and Feasibility Study

JMIR. 2022 Sep14 (website)

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

Assessment of performance characteristics of COVID-19 ICD-10-CM diagnosis code U07.1 using SARS-CoV-2 nucleic acid amplification test results

PLoS One. 2022 Aug 18 (website)

Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-19

PLoS One. 2022 Aug 18 (website)

Operational lessons learned in conducting an international study on pharmacovigilance in pregnancy in resource-constrained settings: The WHO Global Vaccine safety Multi-Country collaboration project

Vaccine: X. 2022 Aug (website)

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 study

BMJ Open. 2022 Jul 08 (website)

Setting The World on FHIR

HL7 Case Study. 2022 Jul (website)

Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases, February-November 2020

BMC Public Health. 2022 Jun 18 (website)

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases

Lancet. 2022 Jun 11 (pdf)

This publication also includes a supplementary appendix and commentary.

Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16-29 years

Vaccine. 2022 Apr 26 (website)

Risk Factors for COVID-19 Deaths Among Elderly Nursing Home Medicare Beneficiaries in the Prevaccine Period

J Infect Dis. 2022 Feb 15 (website)

The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing

Frontiers. 2021 Dec 22 (website)

Risk of Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries

JAMA Intern Med. 2021 Dec 1 (website)

Vaccine exposure during pregnancy among privately and publicly insured women in the United States, 2016–2018

Vaccine. 2021 Oct 01 (pdf)

Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database

Drug Saf. 2021 Sep 30 (website)

Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review

Vaccine. 2021 Sep 24 (website)

Acute myocardial infarction: Development and application of an ICD-10-CM-based algorithm to a large U.S. healthcare claims-based database

PLoS One. 2021 Jul 01 (pdf)

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253580

U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines

Vaccine. 2021 Jun 23 (website)

CBER BEST: Leveraging AI to Build an Automated Adverse Events Reporting System

2021 FDA Science Forum. 2021 May 26 (website)

Presentation begins at the 2:12:00 mark

Natural History of Coronavirus Disease 2019: Risk Factors for Hospitalizations and Deaths Among >26 Million US Medicare Beneficiaries

J Infect Dis. 2021 Mar 29 (website)

Development of an Application That Semi-Automates Clinician Verification and Reporting of Transfusion Allergic Reaction Cases

AABB. 2020 Oct 3-5 (website)

Development of a SMART-on-FHIR-enabled Semi-Automated Adverse Event Validation and Reporting Application

FHIR DevDays. 2020 June (website)

An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for Biologics

DIA PV Meeting Presentation 2020 (pdf)

Biologics Effectiveness and Safety (BEST) Initiative: Sentinel Public Meeting 2019

Sentinel Public Meeting Presentation 2019 (pdf)

Biologics Effectiveness and Safety (BEST) Initiative: First Year

OHDSI Symposium Presentation 2018 (pdf)