A paper from Vaccines Europe in September 2024 reveals “key vulnerabilities” in the vaccine supply chain and offers strategies to strengthen resilience. The paper addresses the “main causes” of vulnerabilities, how manufacturers are addressing the issues disrupting resilience, and how regulators and policymakers can “enhance” these measures to ensure resilience.
“The underlying principle of vaccine supply chain resilience is that the design of supply chain systems should ensure their capacity to recover critical functions when significant disruptions occur. This resilience is based on robust and agile global supply chains.”
Disruptions can include conflict, health threats, or “catastrophes caused by climate change”, and addressing these events demands a “thorough understanding of key vulnerabilities” in the supply chain and the ability to “respond with flexibility and agility”.
Vaccine vulnerabilities
The authors acknowledge the various stages of vaccine development and delivery from manufacturing and testing to regulatory requirements. Vaccines are “often highly technical, complex biological products”. Although the COVID-19 vaccines had a shorter production lead time, the general production lead time is over a year. Additionally, the “complexities and strict requirements of daily performance” affect the vaccine supply chain.
The time required for designing, building, validating, securing regulatory approvals, and starting commercial manufacturing and distribution of a vaccine ranges between 5 and 10 years. Specific manufacturing processes and facilities hinder the expansion of manufacturing capacity when demand increases.
Another limiting factor is the need for different languages on vaccine packs and leaflets; multi-lingual packs are “limited to a maximum of three languages”. This means that “at least 14” different packs are needed for a single presentation of a centrally approved vaccine for coverage across all EU/EEA countries. Manufacturers must “cluster production”.
The COVID-19 pandemic highlighted that “lack of transparency” at any stage in the supply chain can increase the risk of supply shortages. The combination of “unpredictable” demand and a lack of dialogue between manufacturers and health authorities contribute to supply shortages. While some countries conduct “horizon scanning”, other countries do not have these mechanisms in place.
Other factors contribute to supply shortages:
- Environmental factors
- Geopolitical factors
- Economic factors
- Technological factors
- Regulatory factors
- Tender practices
Addressing issues: manufacturers
“Manufacturers are committed to maintaining the supply of vaccines to the community and are therefore implementing a series of measures to reduce potential supply disruptions, where possible and appropriate.”
To deal with threats, vaccine manufacturers have “multiple mitigation plans”:
- Quality systems – good manufacturing practices, staff training, employing qualified personnel, validation of new equipment and facilities
- Proactive risk management (multi-sourcing) – multiple sources for raw materials
- Supply continuity plans – strategies to ensure product delivery is maintained during disruptions
- Fit-for-purpose shortage prevention plans – a risk management process focusing on manufacturing capabilities, sourcing of raw materials, market trends, marketing activities, and product supply
- Updated business contingency plans – plans to resume normal business operations after unintended interruptions like natural disasters, data loss, or demand shifts.
- Diversity of geographical locations of key suppliers – prevents reliance on supplies from the same country/region if disruptions occur
- Inventory management – systems designed to monitor stock levels and order demands
Addressing issues: regulators and policymakers
“Regulators and policymakers can help enable strategies already being employed by vaccine manufacturers and ensure any future policy solutions are proportionate to the risk, carefully considering unintended effects and backed by strong evidence on the nature of shortages.”
Strategies to achieve this include:
- Improving demand forecast transparency: manufacturers must be able to access information on needs and employ a coordinated mechanism for vaccine allocation. The EU and Member States should ensure regulatory expertise and resources and enhance transparency in the decision-making process regarding vaccine assessment. Constant communication with suppliers ensures transparency and successful planning on policy and programme implementation. Data sharing also allows understanding of demand.
- Implement successful strategies from the COVID-19 pandemic during non-pandemic times: policies should support manufacturing capacities, free trade of raw materials and vaccines, and the freedom to select suppliers. Removing export restrictions, opening borders, and ensuring diversified supply chains are “key”. Supply chains can also be strengthened with improved distribution channels to “alleviate bottlenecks”. During the pandemic, “official green lanes (or corridors)” were established to facilitate customs clearance at border crossings. Additional “dialogue on open supply chains with like-minded countries” are “critical in driving sustainable and globally aligned approaches”. Harmonised regulatory standards also provide “system-wide benefits”; the pandemic showed that rolling submissions, potential for electronic or hybrid inspections, conditional marketing authorisations, and acceptance of the EU common pack and electronic Patient Information Leaflet accelerated access. Here, again, information and data sharing are “essential for improved understanding of vaccine demand forecast”.
- Encouraging stakeholder collaboration to create synergies for strengthened resilience: “essential synergies” ensure understanding of the vaccine production process, avoid delays and duplication of work, and shape future activities. Stakeholders must be effectively engaged, and “diverse modes of collaboration” will allow vaccine development within tight timeframes. Communication between national, EU, international health agencies, authorities, and manufacturers is “critical”. Key partnerships during the COVID-19 pandemic “bolstered manufacturing capacity”, enabled technology and knowledge transfer, accelerated research and development, and encouraged “unprecedented” manufacturing scale-up.
- Reducing packaging complexities: the authors encourage the adoption of a common EU packaging accepted by Member States and replacing the paper patient information leaflet with an electronic version (ePIL). Regulatory flexibilities would allow redeployment of inventory between countries.
- Ensuring a highly skilled vaccine manufacturing and supply chain workforce: policy priorities include “upskilling” the EU vaccine workforce and providing support to Member States for improved research, development, and manufacturing capabilities; varied infrastructure and workforce capabilities demand investment.
Collaboration
“Addressing these root causes is largely beyond the control of manufacturers alone and will require mutually feasible and sustainable solutions in collaboration between competent authorities, governments, and industry.”
Vaccines Europe concludes that a complete understand of the end-to-end vaccine production and batch release processes is critical to preventing delays. Optimising collaboration, minimising duplicate efforts, and increasing resilience and agility for the future will “ultimately improve vaccine availability and contribute to better public health”.
We look forward to welcoming Vaccines Europe to the Congress in Barcelona this October for sessions on vaccine development and policy. Get your tickets to join us there, and don’t forget to subscribe to our weekly newsletters here.
