COVID-19 Vaccine BNT162b2 Define-XML Dataset Definitions (EUA & BLA)
These Define-XML files contain comprehensive metadata documentation for Pfizer-BioNTech's BNT162b2 COVID-19 vaccine clinical trial datasets submitted to FDA under both Emergency Use Authorization (EUA) and Biologics License Application (BLA 125742). Each file provides detailed information about dataset structures, variables, controlled terminology, and computational methods used in the BNT162-01 and C4591001 trials.
| Authorization | Study/Protocol | Phase | Data Type | Description | File Links |
|---|
Study BNT162-01: Phase 1/2 dose-escalation study evaluating safety and immunogenicity of BNT162b2 vaccine candidates.
Study C4591001: Phase 1/2/3 pivotal efficacy trial evaluating the safety and efficacy of BNT162b2 in preventing COVID-19.
Nonclinical Studies: Studies 20GR142 and 38166 contain nonclinical toxicology data in SEND format.
ADaM (Analysis Data Model): Contains analysis-ready datasets used for statistical analysis and regulatory submissions.
SDTM (Study Data Tabulation Model): Contains raw clinical trial data in a standardized format.
SEND (Standard for Exchange of Nonclinical Data): Contains nonclinical study data following CDISC standards.