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Vaccine. 2018 Mar 14;36(12):1700-1709. doi: 10.1016/j.vaccine.2018.01.011. Epub 2018 Feb 12.
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.
尽管玻璃包装在疫苗方面存在局限性,但行业在实施替代包装方面一直进展缓慢。聚合物容器可能会解决其中的许多局限性,例如破裂和分层。然而,聚合物容器在成本方面的能力,包括销售成本(COGS)和总成本(TCOD),是否具有竞争力,尚不清楚,尤其是对于成本敏感的低收入和中低收入国家。根据主题专家的信息、已发表的文献和肯尼亚的全面多年免疫计划,为口服和注射疫苗包装格式开发了 COGS 和 TCOD 模型。轮状病毒疫苗和灭活脊灰病毒疫苗(IPV)分别被用作口服和注射疫苗的代表性示例。评估的包装技术包括玻璃小瓶、吹塑-填充-密封(BFS)容器、预制聚合物容器和 BFS 和预制格式的紧凑型预填充自动失效(CPAD)装置。对于口服疫苗包装,BFS 多剂量(MMD)安瓿是最便宜的剂型,每剂的 COGS 为 0.12 美元。相比之下,口服单剂量玻璃小瓶的 COGS 为 0.40 美元。BFS MMD 安瓿的口服疫苗容器 TCOD 最低,每剂 1.19 美元,10 剂量玻璃小瓶的 TCOD 为每剂 1.61 美元。对于注射疫苗,10 剂量玻璃小瓶的 COGS 最低,每剂 0.22 美元。相比之下,预制 CPAD 装置的 COGS 最高,每剂 0.60 美元。10 剂量玻璃小瓶的 TCOD 最低,每剂 1.56 美元。对于注射用疫苗的聚合物容器,BFS MMD 安瓿的 TCOD 最低,每剂 1.89 美元,而预制 CPAD 装置仍然是最昂贵的剂型,每剂 2.25 美元。鉴于它们有可能解决玻璃的局限性并降低 COGS 和 TCOD,聚合物容器值得进一步考虑作为疫苗包装的替代方法。