FDA | Biologics Effectiveness and Safety (BEST)

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)