{
 "_meta": {
  "title": "Vaccine pipeline progress schema and adoption outlook model",
  "built": "2026-10-24",
  "version": "20261024",
  "inputs": {
   "candidates": "vaccine_pipeline_data.json (candidate records, lastUpdated 2026-07-10)",
   "trials": "vaccine_pipeline_ctgov_raw.json (ClinicalTrials.gov v2, fetched 2026-07-10, 1,856 vaccine trials)"
  },
  "how_to_read": "Progress is a position on a fixed ladder, not a probability of success. Projected windows are scenario bands built from the parameters listed here; the slow band is not an upper bound. Bands are only produced for jurisdictions with a verified review target."
 },
 "stages": [
  {
   "id": "preclinical",
   "label": "Preclinical",
   "group": "clinical",
   "progress_percent": 5,
   "description": "Laboratory and animal studies; no human dosing yet."
  },
  {
   "id": "phase_1",
   "label": "Phase 1",
   "group": "clinical",
   "progress_percent": 15,
   "description": "First human studies: safety and dose, usually tens of volunteers."
  },
  {
   "id": "phase_1_2",
   "label": "Phase 1/2",
   "group": "clinical",
   "progress_percent": 25,
   "description": "Combined safety and immune-response study."
  },
  {
   "id": "phase_2",
   "label": "Phase 2",
   "group": "clinical",
   "progress_percent": 35,
   "description": "Immune response and safety in hundreds; dose and schedule chosen."
  },
  {
   "id": "phase_2_3",
   "label": "Phase 2/3",
   "group": "clinical",
   "progress_percent": 45,
   "description": "Seamless design that continues into efficacy testing."
  },
  {
   "id": "phase_3",
   "label": "Phase 3",
   "group": "clinical",
   "progress_percent": 60,
   "description": "Efficacy or immunobridging in thousands; the licensing dataset."
  },
  {
   "id": "regulatory_submission_filed",
   "label": "Submitted to a regulator",
   "group": "regulatory",
   "progress_percent": 75,
   "description": "Biologics licence or marketing application filed in at least one jurisdiction."
  },
  {
   "id": "under_review",
   "label": "Under regulatory review",
   "group": "regulatory",
   "progress_percent": 80,
   "description": "Application accepted and being assessed."
  },
  {
   "id": "approved",
   "label": "Approved / authorised",
   "group": "regulatory",
   "progress_percent": 90,
   "description": "Licence or authorisation granted in at least one jurisdiction."
  },
  {
   "id": "recommended",
   "label": "Recommended for routine use",
   "group": "adoption",
   "progress_percent": 100,
   "description": "A national advisory body (ACIP, JCVI, STIKO, NACI, ATAGI...) has issued a use recommendation."
  }
 ],
 "terminal_states": {
  "discontinued": "Discontinued",
  "withdrawn": "Withdrawn",
  "approved_restricted_or_suspended": "Approved, restricted or suspended"
 },
 "jurisdictions": {
  "US": {
   "label": "United States",
   "regulator": "FDA (CBER)",
   "recommender": "ACIP (CDC)",
   "review_months": {
    "priority": 6,
    "standard": 10
   },
   "review_source": {
    "label": "FDA, Priority Review",
    "url": "https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review",
    "quote": "A Priority Review designation means FDA's goal is to take action on an application within 6 months (compared to 10 months under standard review).",
    "type": "performance goal"
   },
   "decision_lag_months": 0,
   "recommender_months": {
    "fast": 0,
    "typical": 3,
    "slow": 8
   },
   "recommender_source": {
    "label": "CDC, ACIP meeting information",
    "url": "https://www.cdc.gov/acip/meetings/index.html",
    "quote": "The ACIP holds three regular meetings each year to review scientific data and vote on vaccine recommendations.",
    "note": "Three meetings a year implies a typical wait of up to four months for the next regular meeting; 2026 regular meetings were listed as cancelled because of litigation, so the slow band is wider."
   }
  },
  "EU": {
   "label": "European Union",
   "regulator": "EMA (CHMP) and European Commission",
   "recommender": "national bodies (STIKO, HAS, Folkhälsomyndigheten and others)",
   "review_months": {
    "priority": 7,
    "standard": 12
   },
   "review_source": {
    "label": "EMA, the evaluation of medicines step by step",
    "url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-medicines-step-step",
    "quote": "The assessment of a marketing authorisation application for a new medicine takes up to 210 'active' days. ... Overall, the assessment of a new medicine usually lasts around a year. ... The assessment time may be reduced to 150 days instead of 210 days, if the medicine developer is granted accelerated assessment.",
    "type": "procedural maximum plus EMA's own statement of the usual total"
   },
   "decision_lag_months": 2,
   "decision_source": {
    "label": "EMA, obtaining an EU marketing authorisation step by step",
    "url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step",
    "quote": "European Commission decision on the marketing authorisation ... When: Within 67 days of receipt of CHMP opinion",
    "type": "procedural maximum"
   },
   "recommender_months": {
    "fast": 1,
    "typical": 6,
    "slow": 18
   },
   "recommender_source": {
    "label": "assumption",
    "note": "EU recommendations are national; timing varies by country and is not sourced here. Band is a stated assumption."
   }
  },
  "Canada": {
   "label": "Canada",
   "regulator": "Health Canada",
   "recommender": "NACI",
   "review_months": {
    "priority": 6,
    "standard": 10
   },
   "review_source": {
    "label": "Health Canada, performance standards for drug submissions (Table 1: NAS review 300 days; priority 180 days)",
    "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions-applications/performance-standards.html",
    "quote": "The performance standard is the period from the date of acceptance to date of first decision not including any review clock pauses.",
    "type": "performance standard (300 calendar days standard, 180 priority; shown here as months)"
   },
   "decision_lag_months": 0,
   "recommender_months": {
    "fast": 1,
    "typical": 4,
    "slow": 12
   },
   "recommender_source": {
    "label": "assumption",
    "note": "NACI publishes statements after Health Canada authorisation; cadence not sourced here."
   }
  },
  "UK": {
   "label": "United Kingdom",
   "regulator": "MHRA",
   "recommender": "JCVI",
   "review_months": null,
   "review_source": {
    "label": "not verified",
    "note": "The MHRA 150-day national assessment and International Recognition Procedure pages could not be fetched on 2026-10-24; no target is used."
   },
   "decision_lag_months": 0,
   "recommender_months": {
    "fast": 0,
    "typical": 3,
    "slow": 8
   },
   "recommender_source": {
    "label": "GOV.UK, Joint Committee on Vaccination and Immunisation",
    "url": "https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation",
    "quote": "JCVI holds 3 committee meetings a year, usually on the first Wednesday of February, June and October.",
    "type": "stated schedule"
   }
  },
  "Australia": {
   "label": "Australia",
   "regulator": "TGA",
   "recommender": "ATAGI",
   "review_months": null,
   "review_source": {
    "label": "not verified",
    "note": "TGA registration-timeframe pages timed out on 2026-10-24; no target is used."
   },
   "decision_lag_months": 0,
   "recommender_months": null,
   "recommender_source": {
    "label": "not sourced"
   }
  },
  "Japan": {
   "label": "Japan",
   "regulator": "PMDA / MHLW",
   "recommender": "MHLW immunisation subcommittee",
   "review_months": null,
   "review_source": {
    "label": "not verified",
    "note": "PMDA English pages reached on 2026-10-24 state that target review times exist but give no figure."
   },
   "decision_lag_months": 0,
   "recommender_months": null,
   "recommender_source": {
    "label": "not sourced"
   }
  },
  "WHO": {
   "label": "WHO prequalification",
   "regulator": "WHO Prequalification",
   "recommender": "SAGE",
   "review_months": null,
   "review_source": {
    "label": "not verified",
    "note": "WHO prequalification procedure pages returned 404/500 on 2026-10-24; no target is used."
   },
   "decision_lag_months": 0,
   "recommender_months": null,
   "recommender_source": {
    "label": "not sourced"
   }
  }
 },
 "phase_duration_months": {
  "phase_1": {
   "fast": 12.0,
   "typical": 23.0,
   "slow": 42.2,
   "basis": "registry-derived",
   "n_trials": 506
  },
  "phase_1_2": {
   "fast": 13.0,
   "typical": 24,
   "slow": 42.5,
   "basis": "registry-derived",
   "n_trials": 237
  },
  "phase_2": {
   "fast": 13.0,
   "typical": 28,
   "slow": 46.0,
   "basis": "registry-derived",
   "n_trials": 397
  },
  "phase_2_3": {
   "fast": 9.0,
   "typical": 21.5,
   "slow": 29.8,
   "basis": "registry-derived",
   "n_trials": 38
  },
  "phase_3": {
   "fast": 9.0,
   "typical": 18,
   "slow": 39.0,
   "basis": "registry-derived",
   "n_trials": 251
  }
 },
 "phase_duration_basis": "Trial length from start date to primary completion date for vaccine trials in the registry extract, by registered phase; fast = first quartile, typical = median, slow = third quartile. Registry dates are sponsor-entered and primary completion for ongoing trials is an estimate.",
 "inter_phase_gap_months": {
  "fast": 3,
  "typical": 9,
  "slow": 18,
  "basis": "assumption",
  "note": "Time from a trial's primary completion to the next phase's start, or from Phase 3 completion to a regulatory submission. Stated assumption; not sourced."
 },
 "whole_pipeline_benchmark": {
  "label": "Pronker ES et al. 2013, PLoS One, Risk in vaccine research and development quantified (PMID 23526951)",
  "url": "https://pubmed.ncbi.nlm.nih.gov/23526951/",
  "quote": "The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%.",
  "note": "Projects in development 1998-2009. Used as the whole-pipeline benchmark against which the stage-by-stage bands below are sanity-checked; not used in the arithmetic."
 },
 "grade_rule": {
  "A": "Regulator-confirmed status date in at least one jurisdiction and record verified within 12 months.",
  "B": "Company-estimated dates (filings, readouts) and record verified within 12 months.",
  "C": "Stage known from the trial registry only; no jurisdiction-specific filing or decision date.",
  "D": "Record not verified within 12 months, or status conflicts between sources.",
  "none": "Discontinued or withdrawn: tracked, not projected."
 }
}