Vaccines & Immunisation – Non-Clinical Governance Guide (Governance Five™)

In vaccine and immunisation settings, Governance Five™ © is used as a repeatable decision-to-delivery flow for non-clinical questions – for example who is prioritised, how access is structured, how partnerships are governed, or how public commitments are framed and evidenced.

• Govern: Agree non-clinical principles (fairness, equity, transparency, resilience, public value) and define which decisions sit inside the Governance Five™ flow.
• Engage: Identify who must be heard before key non-clinical decisions – for example internal teams, delivery partners, affected communities, technical bodies or oversight forums – and record how they are engaged.
• Aggregate: Bring together data, modelling, logistics constraints, feedback and risk information into a clear, documented basis for each non-clinical decision.
• Deliver: Align contracts, program documents, operating procedures and public communications with what was actually agreed in the Govern / Engage / Aggregate stages.
• Evolve: Use audits, reviews, complaints, disruptions and new evidence to update the non-clinical governance settings – not just fix local problems – and document what changed and why.

This flow can be applied at the level of a manufacturer, national program, global partnership, logistics chain or delivery network. Scientific method, clinical judgement and regulatory approvals remain separate and governed by the appropriate authorities.

Governance Five™ © is concerned with how non-clinical decisions are structured, documented and traced – especially when those decisions affect:

• Access and allocation – who receives which vaccines, when, where and on what terms.
• Affordability and pricing models – tiered pricing, concessional arrangements, public–private contracts and equity settings.
• Program design – how campaigns, rollouts and targeted initiatives are structured across populations and regions.
• Public value and trust – transparency around non-clinical reasoning, partnerships and claimed benefits.
• Partnerships and agreements – multi-party frameworks across manufacturers, governments, multilaterals and logistics providers.

It is especially relevant where vaccine-related work involves:

• Multiple jurisdictions and regulators – different countries, agencies and approval pathways.
• Complex procurement – large contracts, advance purchase agreements, or pooled purchasing mechanisms.
• Blended objectives – health outcomes, equity, resilience, economic stability and geopolitical considerations.
• High public visibility – where decisions may be scrutinised by communities, media, investors and oversight bodies.

In these settings, the Governance Five™ Flow – Govern → Engage → Aggregate → Deliver → Evolve™ © – can provide a single, authored non-clinical governance structure without altering scientific, regulatory or clinical standards.

Vaccine manufacturers and research organisations (for example Pfizer, Moderna and comparable entities) already operate under robust scientific, ethical and regulatory frameworks. Governance Five™ focuses instead on non-clinical decision areas such as:

• How access, allocation and tiered pricing strategies are developed, consulted and documented.
• How non-clinical partnerships (for example with governments, NGOs or global alliances) are structured and governed.
• How public narratives about equity, solidarity or social value are developed and evidence-backed.
• How commitments made in public announcements, ESG reports or investor materials are traced back to internal governance decisions.

Applying Governance Five™ may involve, for example:

• Govern: Setting non-clinical principles for fairness, transparency, accountability and shared value.
• Engage: Structured engagement with affected teams, partners, civil-society actors or advisory groups on key non-clinical choices.
• Aggregate: Bringing together data, scenarios, stakeholder input and risk assessments before finalising non-clinical positions.
• Deliver: Aligning contracts, communications and operational plans with those documented decisions.
• Evolve: Reviewing outcomes, feedback and external scrutiny to refine non-clinical governance over time.

Scientific method, study design, clinical protocols and regulatory compliance remain governed by established scientific and regulatory authorities. Governance Five™ focuses on the non-clinical structures around those processes.

Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and related standards govern quality and safety. Governance Five™ can help organisations show how non-clinical decisions around these systems are made, including:

• Choosing manufacturing locations and capacity allocations across regions.
• Structuring long-term supply contracts with governments, multilaterals or purchasing alliances.
• Balancing commercial, equity and resilience considerations when negotiating terms.
• Documenting how change-control decisions with public impact are governed beyond technical sign-offs.

The Governance Five™ Flow can support a traceable structure for:

• Agreeing non-clinical principles and risk appetite (Govern).
• Engaging relevant internal teams and external stakeholders (Engage).
• Aggregating evidence, scenarios and constraints before approvals (Aggregate).
• Delivering decisions through aligned contracts, processes and communications (Deliver).
• Capturing lessons from disruptions, audits or incidents into governance improvements (Evolve).

This complements, but does not replace, formal quality systems, technical risk management or regulatory oversight.

Health departments and national immunisation programs manage public-interest decisions that go beyond clinical guidance, such as:

• Prioritising population groups and phases when supply is constrained.
• Choosing between different contractual or supply options that carry wider economic or social implications.
• Designing communication strategies and public commitments around equity, access and transparency.
• Balancing emergency responsiveness with long-term program stability.

Governance Five™ can provide a single non-clinical flow to:

• Clarify program mandate and non-clinical principles (Govern).
• Structure engagement with technical experts, communities, providers and oversight bodies (Engage).
• Aggregate data, modelling, logistics and social-impact information before key decisions (Aggregate).
• Align implementation with documented decisions and public statements (Deliver).
• Turn audits, reviews and inquiries into governance learning, not just operational fixes (Evolve).

Technical and scientific advice remains the responsibility of recognised expert bodies and regulators. Governance Five™ focuses on how non-clinical program decisions are structured and evidenced.

Global initiatives and donor-funded programs often involve multiple governments, agencies, NGOs, suppliers and financiers. Non-clinical governance questions may include:

• How allocation rules are developed, consulted and justified.
• How conditions attached to funding are explained and monitored.
• How claims about equity, solidarity or global public good are supported with traceable governance evidence.
• How voice is given to participating countries and communities in program design.

Governance Five™ can help by:

• Making decision pathways visible and documented across institutions.
• Structuring how stakeholders and affected groups are engaged (Engage).
• Showing how information from multiple partners is aggregated before major non-clinical decisions (Aggregate).
• Supporting audit, assurance and public reporting with a consistent method origin (Govern → Deliver → Evolve).

This does not judge policy choices. It focuses on how non-clinical decisions are structured, shared and revisited.

Logistics partners and cold-chain providers sit at the interface of contracts, technical standards and real-world delivery. Governance Five™ supports non-clinical governance where organisations must show:

• How service-level expectations were developed and agreed.
• How risks and contingencies (for example outages, delays, route changes) are governed.
• How information flows between manufacturers, governments, providers and end-delivery sites.
• How lessons from disruptions are fed back into program-level governance.

Using the Governance Five™ Flow, organisations can:

• Clarify non-clinical responsibilities and escalation paths (Govern).
• Show how partners and affected parties are engaged in planning and review (Engage).
• Aggregate performance, incident and capacity data into higher-level governance forums (Aggregate/Evolve).

Technical cold-chain standards still apply. Governance Five™ focuses on how those standards are embedded into wider decision-making and accountability structures.

Community pharmacies, primary-care clinics and mass-vaccination centres operate at the front line of delivery. Non-clinical governance topics may include:

• How eligibility, booking and queue management are designed and explained.
• How access and equity considerations (for example outreach, mobile clinics, accessible locations) are built into planning.
• How complaints, incidents and feedback inform program changes beyond site-level fixes.
• How non-clinical scripts and communication are aligned with official guidance.

Governance Five™ can help providers:

• Document who sets which non-clinical rules and on what basis (Govern).
• Show how staff and, where appropriate, communities are engaged in shaping service models (Engage).
• Aggregate operational data and user experience into higher-level governance reviews (Aggregate/Evolve).

Clinical assessment, consent, safety checks and administration remain governed by professional standards and regulators. Governance Five™ addresses the surrounding non-clinical governance.

Many vaccine and immunisation programs highlight commitments to equity, inclusion and protection of vulnerable groups. Governance Five™ focuses on how these commitments are governed, evidenced and revisited, including:

• How vulnerable or priority groups are identified and consulted in program design.
• How trade-offs and constraints are documented and communicated when not all needs can be met immediately.
• How community, civil-society and local providers contribute to non-clinical decision-making.
• How monitoring and evaluation feed back into governance, not only operational reporting.

The Governance Five™ Flow can assist by:

• Providing a repeatable structure for equity-related non-clinical decisions.
• Showing how voices from affected groups are engaged and how their input is used (Engage/Aggregate).
• Supporting transparent explanations of how and why decisions were made (Deliver/Evolve).

This does not set policy objectives. It helps organisations show that non-clinical choices about equity and access follow a structured, auditable path.

Safety monitoring, pharmacovigilance and scientific communication are governed by expert bodies and regulators. Governance Five™ focuses on the non-clinical governance of how organisations frame and align broader messages about programs, partnerships and public value, for example:

• How cross-agency and cross-organisation messaging is aligned with formal guidance.
• How data about access, uptake and program reach is used in ESG, social-value or impact reports.
• How assurances and commitments made to the public or investors are traced back to agreed governance decisions.
• How organisations learn from communication challenges and adjust non-clinical governance accordingly.

Governance Five™ can support:

• Clear distinction between scientific statements (owned by experts/regulators) and non-clinical program claims.
• Structured engagement with communications, legal, policy and program leads before major announcements.
• Documented pathways from evidence and governance decisions to public narratives.

Governance Five™ does not assess scientific accuracy. It focuses on how non-clinical commitments, claims and assurances are governed and evidenced.

The statements below are examples only. They should be reviewed by your own scientific, regulatory, legal and communications advisors before any external use.

About its role

• “We use Governance Five™ © as a non-clinical governance framework to organise how decisions, participation and documentation are structured around our existing scientific, regulatory and clinical obligations.”
• “Governance Five™ helps us show the path from mandate to engagement, aggregation, delivery and learning for vaccine and immunisation programs that affect access, allocation and public value.”
• “It is a licensed governance system, not a clinical or regulatory tool. It complements, but does not replace, our profession-specific and regulator-specific frameworks.”

About potential non-clinical benefits

• “Using Governance Five™ may improve visibility and traceability across multi-organisation vaccine and immunisation programs.”
• “It can reduce ambiguity about who is involved, when and under what rules in non-clinical decisions.”
• “It helps align engagement, evidence and implementation so that non-clinical decisions are easier to explain to communities, partners, funders and oversight bodies.”

About boundaries

• “Governance Five™ does not provide scientific or clinical advice and does not alter regulatory requirements.”
• “Risk–benefit assessment, efficacy and safety decisions remain the responsibility of the appropriate scientific, clinical and regulatory authorities.”

These examples are for informational purposes. They do not create or remove any obligations. Always confirm wording locally.