FDA | Biologics Effectiveness and Safety (BEST)

Using Double Negative Control Method to Adjust for Unmeasured Confounding When Evaluating Vaccine Effectiveness Among Medicare Older Adults (PDUFA VII Methodology Development Project)

BEST Double Negative Control Protocol (pdf)

Evaluating the Risk of Adverse Events After COVID-19 Diagnosis

Evaluating the Risk of Adverse Events After COVID-19 Diagnosis (pdf)

Assessment of Effectiveness of Booster/Additional Doses of COVID-19 Vaccines in the United States

BEST COVID19 VE Booster Final Report 2024 (pdf)

Assessment of Effectiveness of a Primary Series of Monovalent COVID-19 Vaccination in Adults in the United States

BEST COVID19 VE Primary Series Final Report 2024 (pdf)

Protocol Addendum: Validation of Algorithms to Identify Multisystem Inflammatory Syndrome in Children (MIS-C) in Administrative Claims Data

BEST MIS-C Validation Protocol Addendum 2024 (pdf)

Assessment of Effectiveness of BNT162b2 COVID-19 Vaccination in Children Aged 5 to 17 Years in the United States

BEST Pediatric Vaccine Effectiveness Final Report 2024 (pdf)

Master Protocol: Evaluation of Nine Safety Outcomes following 2023-2024 Influenza Vaccination in Persons 6 Months and Older

BEST Influenza Vaccine Protocol 2023-2024 (pdf)

Evaluation of Multiple Safety Outcomes following 2023-2024 COVID-19 Vaccination in Persons 6 Months and Older

BEST COVID19 Safety Protocol 2023-2024 (pdf)

Evaluation of Multiple Safety Outcomes following Respiratory Syncytial Virus (RSV) Vaccination in Adults 60 Years and Older

BEST RSV Safety Older Adults 2023-2024 (pdf)

FDA Evaluation of a Preliminary Seizure Safety Signal from Rapid Surveillance of Children Ages 2 – 4/5 yrs. following COVID-19 mRNA Vaccination

BEST Prelim Seizure Safety Signal Ages 2-5 2023 (pdf)

Master Protocol: Assessment of the Risk of Adverse Events Following Influenza Vaccinations Approved during the 2022-2023 Influenza Season

BEST 2022-2023 Influenza-AE Protocol 2023 (pdf)

Safety Surveillance of Vaccines Used for Mpox Prevention: Active Monitoring Master Protocol

Mpox-Vax-Safety-Monitoring-Protocol-2022 (pdf)

The Safety Surveillance of Vaccines Used for Mpox Prevention: Active Monitoring Master Protocol was finalized on 12/16/2022. An addendum for this protocol was added on 6/19/2023.

COVID-19 Vaccine Safety Surveillance: Active Monitoring Master Protocol

C19-Vaccine-Safety-Protocol-2021 (pdf)

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 and updated on 12/12/2022. 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. An addendum to this protocol for bivalent vaccine administration in the commercially insured population aged 6 months and older was added 12/23/2022. An addendum to describe the low uptake and discontinuation of near-real time surveillance of Novavax (NVX-CoV2373) COVID-19 vaccine (recombinant, adjuvanted) among the adult population ages 18 years and older was added 3/09/2023.

Assessment of Stroke Following COVID-19 mRNA, Bivalent Booster Vaccination

C19-Post-Bivalent-Stroke-Protocol (pdf)

Evaluating the Risk of Adverse Events After COVID-19 Diagnosis

BEST Post COVID-19 AE Protocol 2023 (pdf)

Risk of Adverse Events of Special Interest Post COVID-19 Vaccines: A Real-World Study Across University of California Health System

Protocol COVID Vaccine AESIs FDA UC (pdf)

Safety Assessment of 3rd Dose/Booster of COVID-19 mRNA Vaccines

C19-Post-Booster-Dose-AESI-Risk-Protocol-2022 (pdf)

Assessment of Effectiveness of COVID-19 Vaccination in the United States Protocol

C19-VX-Effectiveness-Protocol 2022 508 (pdf)

The Assessment of Effectiveness of COVID-19 Vaccination in the United States Protocol was finalized 3/3/2022. An addendum for this protocol for the pediatric population was added 8/18/2022.

Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring

C19-Vax-Safety-AESI-Bkgd-Rate-Protocol-FINAL-2020 (pdf)

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.

Supplementing Administrative Claims COVID-19 Vaccine Data with Immunization Information Systems (IIS) Data: A Feasibility Study Report

IIS-Feasibility-Optum-Study-Report-2022 (pdf)

BETTER: Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance)

BEST BETTER Protocol 2022 (pdf)

Characterization of Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) in Electronic Health Records

Characterization of hospitalized patients with coronavirus disease 2019 (COVID-19) in electronic health records databases (pdf)

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)

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.

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)

Assessment of Risk of Safety Outcomes Following COVID-19 Vaccination Draft Master Protocol

COVID-19-Vaccine-Safety-Inferential-Master-Protocol-Final-2021 (pdf)

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)

Adherence to Administration Schedules of U.S.-Licensed Rotavirus Vaccines for Infants, 2014-2018

Adherence Rotavirus Vaccines Infants Specifications 2020 (pdf)

Final Report: Validating Pregnancy Outcomes and Gestational Age in Claims-EMR Linked Database

Validating Pregnancy Outcomes Linked Database Report 2020 (pdf)

Study Protocol: Validating Pregnancy Outcomes and Gestational Age in a Claims-EMR Linked Database

Validating Pregnancy Outcomes Linked Database Protocol 2020 (pdf)