Pagliusi Sonia, Tippoo Patrick, Sivaramakrishnan Venkatraman, Nguyen Thuvan
DCVMN International, Chemin du Canal 5, 1260 Nyon, Switzerland.
Biovac Institute, 15 Alexandra Road, Pinelands Cape Town 7430 WP, South Africa.
Vaccine. 2014 Nov 12;32(48):6330-5. doi: 10.1016/j.vaccine.2014.05.076. Epub 2014 Jun 9.
New vaccines are required to meet the public health challenges of the next generation and many unmet global health needs can be addressed by developing countries vaccine manufacturers such as lower-cost vaccines based on single-dose, thermostable formulations, efficacious in children with compromised gastrointestinal tracts. GMP compliance is also a challenge, as sometimes innovation and clinical development focus is not accompanied by command of scale-up and quality assurance for large volume manufacturing and supply. Identifying and addressing such challenges, beyond cost and cold-chain space, including safety considerations and health worker behavior, regulatory alliances and harmonization to foster access to vaccines, will help countries to ensure sustainable immunization. There needs to be continuous and close management of the global vaccine supply both at national and international levels, requiring careful risk management, coordination and cooperation with manufacturers. Successful partnership models based on sharing a common goal, mutual respect and good communication were discussed among stakeholders.
新型疫苗对于应对下一代的公共卫生挑战至关重要,许多尚未满足的全球卫生需求可由发展中国家的疫苗制造商来解决,比如基于单剂量、热稳定配方的低成本疫苗,这类疫苗对胃肠道功能受损的儿童有效。符合药品生产质量管理规范(GMP)也是一项挑战,因为有时创新和临床开发重点并未伴随着大规模生产和供应的扩大规模及质量保证能力。识别并应对这些挑战,除了成本和冷链空间问题外,还包括安全考量和卫生工作者行为、监管联盟以及促进疫苗可及性的协调统一,这将有助于各国确保免疫接种的可持续性。国家和国际层面都需要对全球疫苗供应进行持续且密切的管理,这需要谨慎的风险管理以及与制造商的协调合作。利益相关者讨论了基于共同目标、相互尊重和良好沟通的成功伙伴关系模式。