Table 3.
Barriers and opportunities related to the resources and input materials needed for vaccine manufacturing. CDMO: clinical development and manufacturing organization; SME: small and medium-sized enterprises; IFPMA: international federation of pharmaceutical manufacturers and associations; Task Force: this was a vaccine Task Force set up by the government to provide concrete recommendations regarding vaccine production upscaling. MEB: medicines evaluation board. Bullwhip effect: small fluctuations in demand at the retail level can cause progressively larger fluctuations in demand at the raw material supplier level. Ripple effect: a situation in which one event (e.g. a disruption) causes a series of other events to happen.
|
C. Resources and input materials | |||
|---|---|---|---|
| C− Barriers | Source(s) | C+ Opportunities | Source(s) |
| C1− Lack of critical resources and raw materials (e.g., flacons, syringes, cell cultures, filters, single-use bioreactor bags, adjuvants) which can disrupt the entire production chain through compounded risk | CDMO, SME biotech 6, 7, 8, 9, 10, 15, 16 |
C1+ Coordinating and allocating available resources in a centralized manner, e.g., through governments or global initiatives | Task Force, 7, 16 |
| C2− Improper inventory management and material stock-outs | Logistical expert 12, 17, 18 |
C2+ Building flexibility into the production process by making materials interchangeable and by establishing alternative sources of raw materials | 14, 16 |
| C3− Worsening of existing shortages through safety stocking and a bullwhip effect | Logistical expert, 6, 8 |
C3+ Organizing a marketplace and/or matchmaking efforts that link suppliers of raw materials to production chain manufacturers | Task Force, 6 |
| C4− Unfair allocation of available materials amongst countries and manufacturers | CDMO, SME biotech 6, 7, 8 |
C4+ Stretching scare supplies of materials needed in the vaccine production process (e.g., filters) through recycling | 6 |
| C5− Administrative burden posed by export restrictions upon manufacturers and suppliers | Big pharma representative 9 |
C5+ Increasing volumes in flacons or filling vaccines in large multi-dose bags to reduce shortages in glass vials | Logistical expert, vaccine production expert, 7 |
| C6− Reduced availability of materials and disruptions of global supply chains due to export restrictions and protectionist measures | IFPMA representatives 6, 7, 9, 13 |
C6+ Exploring alternative ways of administration (e.g., intranasal, orally or with bio- or microneedle patches) to reduce shortages of traditional syringes | SME biotech, MEB, logistical expert, vaccine production experts, 13, 15 |
| C7− Difficulties in managing supply chains of other life-saving medicines through shortages and a ripple effect | IFMPA representatives 8, 14 |
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| C8− Lack of reliable data and reduced visibility into available resources | 6, 7, 8, 9, 15, 16 | ||