全球监管改革以促进在下一次大流行中获得公平的疫苗接种
Richard Mahoney1, Peter J Hotez1,2,3,4,5, Maria Elena Bottazzi1,2,3
1Texas Children's Hospital Center for Vaccine Development, Department of Pediatrics, Division of Tropical Medicine, Baylor College of Medicine, Houston, Texas, United States of America.
PLOS global public health
|October 18, 2023
概括
由于疫苗接种不公平,全球流行病反应失败了. 加强低收入和中等收入国家 (LMIC) 的监管机构成为严格的监管机构 (SRA) 对未来的流行病准备和公平的疫苗分配至关重要.
科学领域:
- 全球健康 全球健康
- 疫苗学 疫苗学 疫苗学
- 监管科学 监管科学
背景情况:
- 针对COVID-19大流行的应对突出了疫苗接种方面的重大不平等现象,特别是影响低收入和中等收入国家 (LMICs).
- 关键的失败包括过度依赖高收入国家 (HIC) 制造商,疫苗民族主义以及对LMIC监管机构的支持不足.
研究的目的:
- 在未来的流行病中确定确保公平接种疫苗的策略.
- 分析成功的疫苗开发和技术转让模型.
- 建议加强LMIC监管系统,作为流行病准备的关键组成部分.
主要方法:
- 审查了三个成功的疫苗开发和技术转让案例研究:乙型肝炎 (韩国,1980年代),脑膜炎A (PATH/WHO,2000年代) 和SARS-CoV-2疫苗 (德克萨斯儿童医院到印度/印度尼西亚).
- 对成功技术转让和监管批准的因素进行分析.
- 评估加强监管和WHO预资格的作用.
主要成果:
- 成功的案例研究证明了公平的疫苗开发和转让的可行性.
- 加强LMIC国家监管机构 (NRA) 到严格监管机构 (SRA) 的地位对于及时提供疫苗至关重要.
- 重新优先考虑世卫组织预资格 (PQ) 系统可以在卫生危机期间提高LMICs的早期访问.
结论:
- 需要采取积极主动的方法,以避免在未来的流行病中出现疫苗不平等.
- 在升级LMIC监管能力到SRA地位的大量投资是必要的,但为全球卫生安全提供了巨大的好处.
- 拟定一个涉及世卫组织,联合国机构和SRA的合作路线图,以支持LMIC监管机构在2030年之前实现严格的地位.
相关概念视频
Global Regulatory Systems
29
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
29
Drug Control Governance: Regulatory Bodies and Their Impact
163
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
163
Vaccinations
44.6K
Overview
44.6K
International Nursing Organizations II
1.0K
The World Health Organization (WHO) is a specialized agency of the United Nations based in Geneva. The WHO has many initiatives that center around health. Primarily, they lead global efforts to expand universal health coverage using science-based policies and programs. They are also responsible for shaping health research agendas and developing norms and standards.
The WHO provides expert team support, including funding, vaccines, testing, and treatment tools at the country level to fight...
The WHO provides expert team support, including funding, vaccines, testing, and treatment tools at the country level to fight...
1.0K
Microorganisms in Medicine and Therapeutics
35
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
35
Primary Healthcare Services
1.4K
Primary care promotes wellness and prevents disease. This care includes health promotion, education, protection (such as immunizations), early disease screening, and environmental considerations. Settings providing this type of healthcare include physician offices, public health clinics, school nursing, and community health nursing.
In 1978, international leaders convened in Alma-Ata, Kazakhstan, for what would be a pivotal event in global health. The Alma-Ata Declaration was the first to call...
In 1978, international leaders convened in Alma-Ata, Kazakhstan, for what would be a pivotal event in global health. The Alma-Ata Declaration was the first to call...
1.4K


