FDA | Biologics Effectiveness and Safety (BEST)

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



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)


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

Jama Pediatrics. 2023 May 22 (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)


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)


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


Active, surveillance, vaccine

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)


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.


Risk, myocarditis, pericarditis, COVID-19 mRNA vaccinations, administrative claims

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)


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

Vaccine. 2021 Oct 01 (pdf)


Vaccine exposure, pregnancy, Insured women

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

Drug Saf. 2021 Sep 30 (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)



Acute myocardial infarction ICD-10, administrative claims, algorithm

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


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)


DIA PV and Risk Management Strategies Conference

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

Sentinel Public Meeting Presentation 2019 (pdf)


Sentinel Public Meeting 2019

Biologics Effectiveness and Safety (BEST) Initiative: First Year

OHDSI Symposium Presentation 2018 (pdf)


OHDSI Symposium 2018