About COVID-19 Vaccine FOIA Documents
Overview
This site provides access to clinical trial documents submitted to the FDA for COVID-19 vaccines from both Pfizer-BioNTech and Moderna.
The collection includes documents from Emergency Use Authorization (EUA) applications as well as Biologics License Application (BLA)
submissions for full approval. These documents were obtained through Freedom of Information Act (FOIA) requests and represent a
collection of clinical trial data, metadata, safety reports, efficacy analyses, and FDA correspondence.
Document Collection
The collection includes 854 documents spanning multiple modules of the regulatory submission:
- Module 1 (M1): Administrative and prescribing information
- Module 2 (M2): Summaries and overviews
- Module 4 (M4): Nonclinical study reports
- Module 5 (M5): Clinical study reports
Note: Module 3 was not included in the FOIA release. Module 3 covers Quality
information including chemistry, manufacturing, and controls (CMC) data such as drug substance
and drug product manufacturing processes, quality control procedures, stability data, and
facility information.
Data Standards
The clinical trial data follows CDISC (Clinical Data Interchange Standards Consortium) standards:
- SDTM (Study Data Tabulation Model): Standardized format for organizing clinical trial data
- ADaM (Analysis Data Model): Datasets prepared for statistical analysis
- Supplemental Qualifiers: Additional data that extends the standard domains
Understanding the Metadata
This project provides two complementary ways to explore and understand the clinical trial metadata:
Data Dictionary
The Data Dictionary is a searchable, filterable interface that consolidates field definitions across all clinical trial datasets. It allows you to:
- Search for specific variables or terms
- Filter by domain (e.g., adverse events, demographics)
- View standardized definitions and formats
- Understand relationships between different data elements
Define-XML Metadata
The Define-XML Metadata presents the original metadata documentation as submitted to the FDA in the FOIA'd documents. These files:
- Contain the complete, unmodified metadata from each clinical trial
- Follow CDISC Define-XML standards for regulatory submissions
- Include detailed dataset structures, variable definitions, and computational methods
- Are organized by manufacturer (Moderna and Pfizer-BioNTech) and study phase
- Provide both ADaM (analysis) and SDTM (tabulation) metadata for each study
While both resources describe the same underlying clinical trial data, they serve different purposes: the Data Dictionary offers a unified, searchable view across all studies, while the Define-XML files preserve the exact metadata structure and content from the original regulatory submissions.
Using the Navigator
The file navigator provides two main views to explore the documents:
File List View
A comprehensive table showing all documents with the following features:
- Filter by File Type: PDF, Word, XPT (SAS data), XML, and more
- Filter by Document Type: Forms, Reports, Data files, Letters, etc.
- Filter by Domain Type: Clinical data domains (adverse events, demographics, laboratory results)
- Filter by Module: M1, M2, M4, M5, or documents without module designation
- Filter by Folder: Different FOIA release batches (eua-051925, eua-063025)
- Filter by Tags: Search and select from over 1,600 descriptive tags
- Tag Viewing: Click the tag icon to see all tags associated with a document
- Citation: Click "Cite" to get a formatted citation for any document
- Direct Links: Click any filename to open the document in Google Drive
Tag Chart View
An interactive visualization showing:
- All tags sized by frequency (larger = more documents)
- Tags colored by the predominant file type
- Click any tag to filter the file list to documents with that tag
- Sort options: by count (most common first) or alphabetically
Note: This is an unofficial resource created to help researchers and the public
navigate the FOIA'd documents.
Key Features
- Smart Filtering: All filters work together - select multiple criteria to narrow your search
- Dynamic Counts: Filter counts update to show how many documents match as you add filters
- Tag Search: Autocomplete helps you find tags with partial word matching (e.g., search "kinetic" to find "pharmacokinetic")
- Responsive Design: Works on desktop, laptop, and mobile devices
- Export Ready: All documents link to downloadable files on Google Drive
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