Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Maternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, United Kingdom.
PLoS Med. 2023 Mar 14;20(3):e1004068. doi: 10.1371/journal.pmed.1004068. eCollection 2023 Mar.
Group B Streptococcus (GBS) can cause invasive disease (iGBS) in young infants, typically presenting as sepsis or meningitis, and is also associated with stillbirth and preterm birth. GBS vaccines are under development, but their potential health impact and cost-effectiveness have not been assessed globally.
We assessed the health impact and value (using net monetary benefit (NMB), which measures both health and economic effects of vaccination into monetary units) of GBS maternal vaccination in an annual cohort of 140 million pregnant women across 183 countries in 2020. Our analysis uses a decision tree model, incorporating risks of GBS-related health outcomes from an existing Bayesian disease burden model. We extrapolated country-specific GBS-related healthcare costs using data from a previous systematic review and calculated quality-adjusted life years (QALYs) lost due to infant mortality and long-term disability. We assumed 80% vaccine efficacy against iGBS and stillbirth, following the WHO Preferred Product Characteristics, and coverage based on the proportion of pregnant women receiving at least 4 antenatal visits. One dose was assumed to cost $50 in high-income countries, $15 in upper-middle income countries, and $3.50 in low-/lower-middle-income countries. We estimated NMB using alternative normative assumptions that may be adopted by policymakers. Vaccinating pregnant women could avert 127,000 (95% uncertainty range 63,300 to 248,000) early-onset and 87,300 (38,100 to 209,000) late-onset infant iGBS cases, 31,100 deaths (14,400 to 66,400), 17,900 (6,380 to 49,900) cases of moderate and severe neurodevelopmental impairment, and 23,000 (10,000 to 56,400) stillbirths. A vaccine effective against GBS-associated prematurity might also avert 185,000 (13,500 to 407,000) preterm births. Globally, a 1-dose vaccine programme could cost $1.7 billion but save $385 million in healthcare costs. Estimated global NMB ranged from $1.1 billion ($-0.2 to 3.8 billion) under the least favourable normative assumptions to $17 billion ($9.1 to 31 billion) under the most favourable normative assumptions. The main limitation of our analysis was the scarcity of data to inform some of the model parameters such as those governing health-related quality of life and long-term costs from disability, and how these parameters may vary across country contexts.
In this study, we found that maternal GBS vaccination could have a large impact on infant morbidity and mortality. Globally, a GBS maternal vaccine at reasonable prices is likely to be a cost-effective intervention.
B 群链球菌(GBS)可导致婴幼儿侵袭性疾病(iGBS),通常表现为败血症或脑膜炎,也与死产和早产有关。GBS 疫苗正在开发中,但尚未在全球范围内评估其潜在的健康影响和成本效益。
我们在 2020 年对 183 个国家/地区的 1.4 亿名孕妇进行了年度队列评估,评估了 GBS 母体疫苗接种的健康影响和价值(使用净货币收益(NMB),该指标衡量疫苗接种对健康和经济的影响)。我们的分析使用决策树模型,结合了现有贝叶斯疾病负担模型中与 GBS 相关的健康结果风险。我们使用先前系统评价的数据推断与 GBS 相关的国家特定医疗保健费用,并计算因婴儿死亡和长期残疾而导致的丧失质量调整生命年(QALY)。我们假设 80%的疫苗对 iGBS 和死产有效,这与世界卫生组织的首选产品特征一致,接种率基于接受至少 4 次产前检查的孕妇比例。我们假设一剂疫苗在高收入国家的成本为 50 美元,中高收入国家为 15 美元,低收入/中低收入国家为 3.50 美元。我们使用决策者可能采用的替代规范假设来估计 NMB。接种孕妇疫苗可预防 127,000 例(95%不确定性范围为 63,300 至 248,000)早发和 87,300 例(38,100 至 209,000)晚发婴儿 iGBS 病例,31,100 例死亡(14,400 至 66,400),17,900 例(6,380 至 49,900)例中度和重度神经发育障碍,23,000 例(10,000 至 56,400)例死产。预防 GBS 相关早产的疫苗也可能预防 185,000 例(13,500 至 407,000)早产。在全球范围内,一项 1 剂疫苗接种计划可能耗资 17 亿美元,但可节省 3.85 亿美元的医疗保健费用。根据最不利的规范假设,估计的全球 NMB 范围为 11 亿美元(-0.2 亿至 38 亿美元),根据最有利的规范假设,估计的全球 NMB 范围为 170 亿美元(91 亿至 310 亿美元)。我们分析的主要限制是缺乏数据来告知一些模型参数,例如与健康相关的生活质量和残疾长期成本的参数,以及这些参数如何在国家背景下变化。
在这项研究中,我们发现母体 GBS 疫苗接种可能对婴儿发病率和死亡率产生重大影响。在全球范围内,合理价格的 GBS 母体疫苗可能是一种具有成本效益的干预措施。