Vaccine Data Navigator Open Source Medicine Foundation

Open Source Medicine Foundation

About & Methodology

Vaccine Data Navigator is an open-access pharmacovigilance and immunization evidence synthesizer. We provide transparent, citation-backed access to regulatory filings, clinical trials, and international post-market surveillance.

Authorship & Mission

Vaccine Data Navigator is compiled and maintained by the Open Source Medicine Foundation (OSMF), an independent non-profit research foundation dedicated to transparent, reproducible, and verifiable medical evidence synthesis.

Our mission is to empower parents, patients, clinicians, and researchers with structured, neutral, and direct access to primary evidence. We synthesize pre-licensure randomized controlled trial results, package insert warnings, post-market spontaneous reports, active surveillance findings, and international schedule policies without promotional or dismissive spin.

Editorial Independence: OSMF accepts no pharmaceutical industry sponsorship or government public relations grants. All code, data parsers, and synthesis pipelines are open-source.

Evidence Structure Per Vaccine Page

Every individual vaccine evidence summary adheres to a strict 9-section template designed to present complete information from primary regulatory and peer-reviewed sources:

1. Basic Information

Diseases targeted, clinical severity, transmission modes, US-licensed products, manufacturers, licensure dates, and antigen formulations.

2. Ingredients & Manufacturing

Antigen quantities, adjuvants (aluminum salts, novel lipid systems), preservatives, stabilizers, residual growth media proteins, and antibiotics per dose.

3. Efficacy & Effectiveness

Pre-licensure randomized controlled trial (RCT) results, post-licensure observational effectiveness, duration of protection, and waning antibody kinetics.

4. Safety Profile & Clinical Trials

Pivotal trial safety data: participant cohorts, control groups (saline placebo vs. active comparator vs. adjuvant control), observation windows, and reactogenicity.

5. Post-Marketing Surveillance

Signals from VAERS, Vaccine Safety Datalink (VSD), PRISM, Lareb, EudraVigilance, Yellow Card, and DAEN, including Brighton Collaboration case definitions.

6. International Schedule Comparison

Comparison across ~30 countries: recommended ages, primary series vs. booster timing, target population criteria, and mandatory vs. voluntary status.

7. Vaccine Injury Compensation

HRSA National Vaccine Injury Compensation Program (VICP) and Countermeasures Injury Compensation Program (CICP) petition and adjudication records.

8. Risk-Benefit Context & Limitations

Disease burden vs. adverse outcome frequencies, high-risk group variations, unanswered research questions, and documented surveillance blind spots.

9. Key References & Package Inserts

Direct links to official FDA package inserts, ACIP recommendations, Cochrane Systematic Reviews, and landmark peer-reviewed studies.

Primary Data Sources

Our data ingestion and synthesis pipelines draw strictly from primary regulatory filings and established health agency surveillance databases:

  • FDA Package Inserts & Approval Documents: Section 6 (Adverse Reactions), Section 11 (Description), Section 13 (Nonclinical Toxicology), and Section 14 (Clinical Studies).
  • CDC & ACIP Statements: Advisory Committee on Immunization Practices recommendations and Morbidity and Mortality Weekly Reports (MMWR).
  • Spontaneous Reporting Systems: U.S. VAERS (CDC/FDA), Netherlands Lareb, UK MHRA Yellow Card, EMA EudraVigilance, Australia TGA DAEN, and WHO VigiAccess.
  • Active Surveillance & Cohort Databases: CDC Vaccine Safety Datalink (VSD), FDA Biologics Effectiveness and Safety (BEST) system, and PRISM.
  • Compensation Adjudication Data: HRSA Data Reports for VICP and CICP filed claims, compensated cases, and tabletop injury categories.
  • Systematic Reviews & Consensus Reports: Cochrane Collaboration Systematic Reviews, Institute of Medicine (IOM) / National Academies of Sciences, Engineering, and Medicine (NASEM) consensus reviews.

Understanding Evidence Quality & Grading

Pharmacovigilance requires distinguishing between spontaneous report counts and confirmed causal rates:

Spontaneous Pharmacovigilance Data: Systems such as VAERS, EudraVigilance, and Yellow Card capture unverified spontaneous reports. A report does not establish that a vaccine caused the adverse event. Spontaneous databases are hypothesis-generating signal detection tools subject to reporting bias and missing denominators.
Epidemiological & Active Surveillance Studies: Controlled cohort studies, self-controlled case series (SCCS), and active surveillance (such as VSD) calculate attributable risk and incidence rate ratios with defined population denominators.

* Note: While individual vaccine pages specify whether evidence originates from pre-licensure RCTs, active surveillance, or passive reporting, an integrated formal GRADE-matrix system is continuously being expanded across all condition sub-tables.

Corrections, Verification & Feedback

Vaccine Data Navigator is an open-source project committed to scientific rigor and empirical accuracy. If you identify a factual discrepancy, outdated package insert link, or missing primary study:

  • Submit corrections directly via the OSMF Contact Portal.
  • Provide the specific URL, the exact data point in question, and the primary source citation (e.g., FDA BLA number, PubMed ID, or agency report).
  • Submissions are reviewed by OSMF researchers and corrected promptly.