McGoldrick Mic, Truong Tran Ba Quang, Campa Cristiana, Ali Murtuza, Guzzi Antonio, Van Ooij Mark, Feuillet Cecile, Eck Jennifer
Merck & Co., Inc., Kenilworth, NJ, USA.
Sanofi Pasteur, France.
Vaccine. 2025 Mar 7;49:126782. doi: 10.1016/j.vaccine.2025.126782. Epub 2025 Jan 31.
When the Covid-19 pandemic was declared by WHO, a team of vaccine manufacturers worked with the COVAX (COVID-19 Vaccine Global Access) Manufacturing SWAT (Support Work to Advance) team to propose regulatory agilities for accelerating access to vaccines. The cooperation and success demonstrated during the pandemic demonstrated the benefits of simplifying requirements and reliance. Vaccine developers, manufacturers, the Coalition for Epidemic Preparedness Innovations (CEPI), and other stakeholders have engaged in discussions to highlight the lessons learned from this experience and to find solutions to address those challenges. This paper discusses efforts to accelerate pandemic preparedness and reports a comparative assessment of early and later pandemic experiences from vaccine manufacturers. The lessons learned and the risk-based approaches were invaluable in bringing vaccines to patients. However, the shift from cooperative pandemic pathways to strict non-pandemic requirements can impact supply. Flexibility and reliance are still needed to ensure timely product availability. This article emphasizes the importance of continuing pandemic preparedness and acting on lessons learned.
当世界卫生组织宣布新冠疫情大流行时，一组疫苗制造商与COVAX（新冠疫苗全球获取）制造特别行动小组（推进支持工作）合作，提出加快疫苗获取的监管灵活性措施。疫情期间展现出的合作与成功证明了简化要求和相互依赖的益处。疫苗开发者、制造商、流行病防范创新联盟（CEPI）及其他利益相关者参与了讨论，以突出从这一经历中吸取的经验教训，并找到应对这些挑战的解决方案。本文讨论了加速大流行防范的努力，并报告了疫苗制造商对早期和后期大流行经历的比较评估。吸取的经验教训和基于风险的方法对于将疫苗提供给患者非常宝贵。然而，从合作的大流行途径转向严格的非大流行要求可能会影响供应。仍需要灵活性和相互依赖以确保产品及时供应。本文强调了持续进行大流行防范并根据吸取的经验教训采取行动的重要性。
