fda-catalyst-vaccines

Methodology inspired by publicly taught vaccine commercial frameworks; all text is an original paraphrase.

Defaults

Parameter	Default Value	Rationale
forward_window_quarters	4	Standard catalyst window; extend to 8 on request
include_superseded	false	Active-only events by default; supersede chains on request
acip_gate	true	ACIP status always shown next to FDA decisions — approval is not availability
procurement_lens	true	Government purchasing and campaign milestones tracked
holiday_labeling	true	Holiday-shifted weeks flagged on every calendar row

Preflight

Run canonical pre-flight per contracts/preflight.md. Include the X-Agentii-Trace header on every tool call per contracts/x-agentii-trace-header.md — carry the _run_id from your first tool result and name yourself (and your parent, if you were spawned). Confirm ticker resolution via search_companies before catalyst queries.

Triggers

• "When is [vaccine]'s ACIP meeting, and what is the vote outlook?"
• "Is [vaccine] FDA-approved but still awaiting an ACIP recommendation?"
• "What does the ACIP vote mean for [ticker]'s commercial launch?"
• "What procurement milestones are pending for [vaccine/ticker]?"
• "When is lot release expected for [vaccine]?"
• "What pediatric or age-cohort bridging studies are pending?"
• "Build a vaccine catalyst calendar for my watchlist."
• "Which vaccine decisions land this quarter?"
• "How do ACIP recommendation categories change uptake?"
• "What happens between FDA approval and commercial availability?"
• "Which vaccine catalysts overlap with [ticker]'s earnings date?"
• "How did similar vaccines trade around their ACIP votes?"

Production Grounding

• Two-gate path: FDA approval (CBER BLA) is necessary but not sufficient — the ACIP row (scheduled → voted → adopted) is the gate data, with CDC Director sign-off and MMWR publication distinct steps from the vote.
• ACIP recommendation categories (routine / catch-up / risk-based / shared-clinical-decision-making) set the uptake ceiling; votes move stocks like PDUFA dates move drug names.
• CBER context: healthy-population efficacy bar (large N, safety-first), lot-release testing, and manufacturing capacity as a catalyst in its own right.
• Procurement milestones: government stockpiles and purchase contracts (doses/serials, procurement value), seasonal campaign timing.
• Pediatric bridging, booster cycles, and age-cohort expansions re-open the catalyst window after launch.
• Holiday-week labeling discipline: campaign-week comps are noisy; label holiday weeks explicitly. Never fabricate votes, dates, or procurement values (per references/knowledge-frameworks.md).

Data Source Priority

1. ACIP gate data: search_acip_events / get_acip_event (vote counts, status ladder).
2. FDA/CBER track: get_upcoming_pdufa / search_fda_approvals (BLA events).
3. Panel and filing context: search_adcom_meetings (VRBPAC) + search_documents / search_sec_filings for procurement and lot-release disclosures.
4. Historical grounding: search_investment_cases (acip_vote/approval events), search_by_analogue.

Methodology

Retrieval Scope

unstructured_document_search

Retrieval Strategy

1. Resolve ticker(s) via search_companies; note vaccine product names.
2. Pull ACIP events (search_acip_events) and FDA-track dates (get_upcoming_pdufa); pair them per product.
3. For each ACIP event, retrieve vote detail (get_acip_event by vaccine + meeting date) and panel context.
4. Layer procurement and lot-release milestones from filings (search_sec_filings 8-Ks, search_documents).
5. Ground the play: search_investment_cases / search_by_analogue with vaccine filters; cite /v/ records.

Temporal Scope

See frontmatter temporal_scope block. Seasonal campaigns may require looking back up to 8 quarters.

Tool Allowlist

See frontmatter allowed_tools.

Protocol

1. Ticker resolution
2. Two-gate enumeration (FDA date + ACIP row per product)
3. Per-event vote framing (recommendation category + history)
4. Procurement and lot-release overlay
5. Calendar synthesis + commercial-availability flags

Modes

• Watchlist (default, multi-ticker): one dated calendar with per-ticker sections, sorted by date.
• Single ticker deep-dive: full two-gate timeline per vaccine + procurement state.
• ACIP gate: approval-to-recommendation transition tracking across names.

Tool Fallbacks

Failure	Fallback
search_acip_events empty	search_documents keyword ACIP + search_sec_filings; annotate coverage_gap
No ACIP row for a product	Flag the unmodeled commercial step explicitly; never assume approval = launch
Procurement data missing	State purchase-contract data unavailable; do not estimate values
Knowledge tools empty	Proceed with structured data only; annotate knowledge coverage_gap

Output File

{ticker}/{YYYY-MM-DD_HHMM}_fda-catalyst-vaccines_{affix}.md (watchlist: watchlist/{YYYY-MM-DD_HHMM}_fda-catalyst-vaccines-calendar_{affix}.md)

Output Structure

1. Executive Summary — highest-impact vaccine catalysts in the window, 2-3 sentences
2. Two-Gate Calendar — dated table: date, ticker, product, FDA event, ACIP row, holiday-week flag, availability framing
3. Per-Event Analysis — vote context (recommendation category, committee read) + decision history
4. Procurement & Lot Release — contracts, stockpile status, campaign timing
5. Historical Analogues — matched vaccine cases with /v/ citations and quantified outcomes
6. Risk Assessment & Coverage Gaps — binary-risk sizing, two-gate failure modes, missing data

Error Handling

Error	Fallback
No ACIP or PDUFA rows	Fall back to earnings + pipeline events; annotate coverage_gap — never fabricate dates
Approval without ACIP row	Present the gap as the central risk; do not imply commercial availability
Ticker not in med universe	Resolve via CIK/vaccine-universe match; surface the classification gap

Memory Load

See contracts/memory-load.md.

Snapshot

See contracts/snapshot-synthesis.md.

Final Summary (TUI)

Include ### Key Citations block with 0-10 clickable /v/ URLs.

References

• contracts/citation-and-memory.md
• contracts/output-frontmatter-schema.md
• contracts/memory-load.md
• contracts/snapshot-synthesis.md
• contracts/preflight.md
• references/knowledge-frameworks.md