PATH, Center for Vaccine Innovation and Access, Geneva, Switzerland.
PATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Hum Vaccin Immunother. 2022 Dec 31;18(1):2040329. doi: 10.1080/21645515.2022.2040329. Epub 2022 Mar 3.
While current live, oral rotavirus vaccines (LORVs) are reducing severe diarrhea everywhere, their effectiveness is lower in high burden settings. Alternative approaches are in advanced stages of clinical development, including injectable next-generation rotavirus vaccine (iNGRV) candidates, which have the potential to better protect children, be combined with existing routine immunizations and be more affordable than current LORVs. In an effort to better understand the real public health value of iNGRVs and to help inform decisions by international agencies, funders, and vaccine manufacturers, we conducted an impact and cost-effectiveness analysis examining 20 rotavirus vaccine use cases. We evaluated several currently licensed LORVs, one neonatal oral NGRV (oNGRV), one iNGRV, and one iNGRV-DTP (iNGRV comprising part of a DTP-containing combination) over a ten-year timeframe in 137 low- and middle-income countries. The most promising use case identified was a high efficacy iNGRV-DTP, predicted to have the lowest vaccine program cost (US$1.4 billion), the highest vaccine benefit (750,000 rotavirus deaths averted, 13 million rotavirus hospital admissions averted, US$ 2.7 billion health-care cost averted), and most favorable cost-effectiveness (cost-saving). iNGRV-DTP vaccine remained the most affordable, safe, and cost-effective option even when it was assumed to have equivalent efficacy to the current LORVs. This study shows that while the development of iNGRVs with superior efficacy to currently licensed LORVs would be ideal, iNGRVs with similar efficacy to LORVs would offer substantial public health value. It also highlights the economic value of accelerating the development of DTP-based combination vaccines that include iNGRV to provide rotavirus protection.
虽然目前的口服活轮状病毒疫苗（LORV）在各地都在减少严重腹泻，但在高负担地区的效果较低。替代方法处于临床开发的高级阶段，包括可注射的下一代轮状病毒疫苗（iNGRV）候选疫苗，这些疫苗有可能更好地保护儿童，与现有的常规免疫相结合，并且比目前的 LORV 更实惠。为了更好地了解 iNGRV 的实际公共卫生价值，并为国际机构、资助者和疫苗制造商的决策提供信息，我们进行了一项影响和成本效益分析，评估了 20 种轮状病毒疫苗的使用情况。我们在 137 个低收入和中等收入国家的十年时间内评估了几种目前许可的 LORV、一种新生儿口服 NGRV（oNGRV）、一种 iNGRV 和一种 iNGRV-DTP（包含 DTP 的组合部分的 iNGRV）。确定的最有前途的使用案例是一种高疗效的 iNGRV-DTP，预计疫苗方案成本最低（14 亿美元），疫苗效益最高（预防 75 万例轮状病毒死亡，预防 1300 万例轮状病毒住院，预防 27 亿美元医疗保健费用），具有最佳的成本效益（节省成本）。即使假设 iNGRV 与目前的 LORV 具有等效疗效，iNGRV-DTP 疫苗仍然是最负担得起、最安全和最具成本效益的选择。本研究表明，虽然开发具有优于目前许可的 LORV 的疗效的 iNGRV 是理想的，但具有与 LORV 相似疗效的 iNGRV 将提供重大的公共卫生价值。它还强调了加速开发基于 DTP 的组合疫苗的经济价值，这些疫苗包括 iNGRV，以提供轮状病毒保护。
