Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats

Abstract

Despite limitations of glass packaging for vaccines, the industry has been slow to implement alternative formats. Polymer containers may address many of these limitations, such as breakage and delamination. However, the ability of polymer containers to achieve cost of goods sold (COGS) and total cost of delivery (TCOD) competitive with that of glass containers is unclear, especially for cost-sensitive low- and lower-middle-income countries. COGS and TCOD models for oral and parenteral vaccine packaging formats were developed based on information from subject matter experts, published literature, and Kenya's comprehensive multiyear plan for immunization. Rotavirus and inactivated poliovirus vaccines (IPV) were used as representative examples of oral and parenteral vaccines, respectively. Packaging technologies evaluated included glass vials, blow-fill-seal (BFS) containers, preformed polymer containers, and compact prefilled auto-disable (CPAD) devices in both BFS and preformed formats. For oral vaccine packaging, BFS multi-monodose (MMD) ampoules were the least expensive format, with a COGS of $0.12 per dose. In comparison, oral single-dose glass vials had a COGS of $0.40. BFS MMD ampoules had the lowest TCOD of oral vaccine containers at $1.19 per dose delivered, and ten-dose glass vials had a TCOD of $1.61 per dose delivered. For parenteral vaccines, the lowest COGS was achieved with ten-dose glass vials at $0.22 per dose. In contrast, preformed CPAD devices had the highest COGS at $0.60 per dose. Ten-dose glass vials achieved the lowest TCOD of the parenteral vaccine formats at $1.56 per dose delivered. Of the polymer containers for parenteral vaccines, BFS MMD ampoules achieved the lowest TCOD at $1.89 per dose delivered, whereas preformed CPAD devices remained the most expensive format, at $2.25 per dose delivered. Given their potential to address the limitations of glass and reduce COGS and TCOD, polymer containers deserve further consideration as alternative approaches for vaccine packaging.

Keywords: Cost of delivery; Manufacturing cost; Packaging; Poliovirus; Rotavirus; Vaccine.

Fig. 1

Depiction of the model flow and boundaries of each model.

Fig. 2

Representative examples of the devices evaluated in the cost of goods sold and total cost of delivery models. (A) Oral BFS MMD ampoule; (B) preformed polymer tube; (C) BFS CPAD devices with and without separately packaged needle attached (not shown: BFS CPAD device prior to removal from five-dose card); (D) preformed CPAD device (Uniject™ injection system shown as a representative example); (E) parenteral BFS MMD ampoule (image shown is a three-dimensional printed prototype); and (F) glass vials (left to right: 2R/31 mm single-dose vial for oral and parenteral vaccines, 4R ten-dose vial for parenteral vaccines, and 20R ten-dose glass vial for oral vaccines). Abbreviations: BFS, blow-fill-seal; CPAD, compact prefilled auto-disable; MMD, multi-monodose.

Fig. 3

Cost of goods sold for (A) oral and (B) parenteral vaccine containers with a breakdown of cost by category. Values shown on a cost per dose basis in US dollars ($). Fill-finish costs included everything except the vaccine and delivery device. Abbreviations: BFS, blow-fill-seal; CPAD, compact prefilled auto-disable; MMD, multi-monodose.

Fig. 4

Total cost of delivery for (A) oral rotavirus vaccine and (B) parenteral IPV for routine immunization in Kenya. Values shown on a cost per dose basis in US dollars ($). ^*Vaccine cost was the output of the COGS analysis, including programmatic wastage. Abbreviations: BFS, blow-fill-seal; CPAD, compact prefilled auto-disable; MMD, multi-monodose.

Fig. 5

Sensitivity analysis for (A) oral and (B) parenteral vaccine packaging formats, showing the impact of variability in percentage overfill on COGS. Values shown on a cost per dose basis in US dollars. Abbreviations: BFS, blow-fill-seal; CPAD, compact prefilled auto-disable; MMD, multi-monodose; COGS, cost of goods sold.

Fig. 6

Sensitivity analysis for (A) oral and (B) parenteral vaccine packaging formats, showing the impact of variability of overfill and packaged volume on TCOD. Values shown on a cost per dose basis in US dollars ($). Abbreviations: BFS, blow-fill-seal; CPAD, compact prefilled auto-disable; MMD, multi-monodose; TCOD, total cost of delivery.