Merck & Co., Inc., Kenilworth, NJ, USA.
Sanofi Pasteur, France.
Vaccine. 2022 Feb 23;40(9):1215-1222. doi: 10.1016/j.vaccine.2021.11.098.
The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is an unprecedented achievement in an environment that was not ready to manage such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be addressed in the system in order to streamline the regulatory processes and be in a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people across the globe. More precisely, trade-offs had to be made between the need for regulatory flexibility in the requirements for manufacturing and controls to enable rapid availability of large volumes of vaccines vs the increased stringency and the lack of harmonization in the regulatory environment for vaccines globally. It is also characterized by a high heterogeneity in terms of review and approval processes, limiting equitable and timely access. We review and highlight the challenges relating to several topics, including process validation, comparability, stability, post-approval-changes, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines which provide solutions for the regulatory concerns, (1) science- and risk-based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. These solutions are not new and have been previously highlighted. In recent months, we have seen some progress at the health authority level, but still much needs to be done. It is now time to reflect on the first lessons learnt from a devastating pandemic to ultimately ensure quick and wide access to medicines and vaccines for the citizens and patients.
COVID-19 大流行表明，疫苗面临着前所未有的挑战，而疫苗被广泛认为是摆脱这场大流行的最重要工具。我们见证了疫苗科学家、开发者、制造商和利益相关者在短短一年内推出了几种疫苗。在尚未准备好应对如此全球性公共卫生危机的环境下，这是一项前所未有的成就。事实上，大流行凸显了一些系统中需要解决的障碍，以便简化监管流程，并确保将救生药物解决方案（如疫苗）快速公平地提供给全球各地的人们。更确切地说，需要在制造和控制要求的监管灵活性与疫苗监管环境的更高严格性和缺乏协调之间做出权衡，以快速提供大量疫苗。疫苗的监管环境还具有很高的变异性，在审查和批准流程方面存在限制，限制了公平和及时的获取。我们审查并强调了与几个主题相关的挑战，包括工艺验证、可比性、稳定性、批准后变更、放行测试、包装、转基因生物体和变体。我们看到了加速疫苗获取的四个领域，这些领域为监管问题提供了解决方案，包括（1）基于科学和风险的方法、（2）全球监管协调、（3）利用依赖关系、工作分担和认可流程、（4）数字化。这些解决方案并非新的，以前已经强调过。最近几个月，我们在卫生当局一级看到了一些进展，但仍有许多工作要做。现在是时候从破坏性大流行中吸取第一堂课，最终确保公民和患者能够快速广泛地获得药品和疫苗了。
