International Vaccine Access Center, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Vaccines & Sustainability, GAVI Alliance, Geneva, Geneva, Switzerland.
BMJ Glob Health. 2021 May;6(5). doi: 10.1136/bmjgh-2021-005032.
Previous studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have not been comprehensively assessed across the portfolio of Gavi-supported vaccines.
We analysed median times between introduction milestones from vaccine licensure to country introduction and uptake across six vaccine-preventable diseases (VPDs), three delivery platforms and 69 Gavi-supported countries. Data were gathered from public, partner and manufacturer records. VPDs and prequalified vaccines analysed included type b (DTwP-HepB-Hib, pentavalent), pneumococcal disease (pneumococcal conjugate vaccine, PCV), rotavirus diarrhoea (rotavirus vaccine, RVV), cervical cancer (human papillomavirus vaccine, HPV), polio (inactivated polio vaccine, IPV) and meningococcal meningitis (meningococcal group A conjugate vaccine, MenA).
Median time from first vaccine licensure to first Gavi-supported country introduction across VPDs at a 'global level' (Gavi-supported countries) was 5.4 years. Once licensed, MenA vaccines reached first introduction fastest (campaign=0.6 years; routine immunisation (RI)=1.7 years). Most introductions were delayed. Country uptake following first introduction was accelerated for more recently Gavi-supported RI vaccines compared with older ones.
Factors accelerating timelines across delivery platforms included rapid product prequalifications by WHO, strong initial recommendations by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, achieving target product profiles on first vaccine licensure within a VPD and completing several VPD milestones at a global level prior to licensure. Milestones required for introduction in Gavi-supported countries should start prior or in parallel to licensure to accelerate uptake of vaccines delivered through diverse delivery platforms.
先前的研究确定了影响个别疫苗监管批准到引入时间的因素。然而，尚未全面评估加菲支持的疫苗组合中的引入和采用时间。
我们分析了六种疫苗可预防疾病（VPD）、三种疫苗接种平台和 69 个加菲支持的国家，从疫苗许可到国家引入和采用的中间里程碑之间的中位数时间。数据来自公共、合作伙伴和制造商的记录。分析的 VPD 和预认证疫苗包括 b 型（DTwP-HepB-Hib、五价）、肺炎球菌病（肺炎球菌结合疫苗、PCV）、轮状病毒腹泻（轮状病毒疫苗、Rvv）、宫颈癌（人乳头瘤病毒疫苗、HPV）、脊髓灰质炎（灭活脊髓灰质炎疫苗、IPV）和脑膜炎球菌性脑膜炎（脑膜炎球菌 A 结合疫苗、MenA）。
在“全球层面”（加菲支持的国家），从第一种疫苗获得许可到第一种加菲支持的国家引入 VPD 的中位数时间为 5.4 年。一旦获得许可，MenA 疫苗的首次引入最快（疫苗接种=0.6 年；常规免疫接种（RI）=1.7 年）。大多数引入都被推迟了。与较旧的疫苗相比，在首次引入后的国家采用速度加快了最近获得加菲支持的 RI 疫苗。
加速各疫苗接种平台时间线的因素包括世卫组织的快速产品预认证、世卫组织免疫战略咨询专家组（SAGE）的强烈初步建议、在 VPD 中首次获得疫苗许可时实现目标产品概况以及在获得许可之前完成多个 VPD 里程碑。在加菲支持的国家引入所需的里程碑应在许可之前或与许可同时开始，以加速通过各种疫苗接种平台提供的疫苗的采用。
