Skerritt John H
Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC 3010, Australia.
Vaccines (Basel). 2025 Apr 28;13(5):473. doi: 10.3390/vaccines13050473.
With the successful deployment of several mRNA vaccines against SARS-CoV-2, an mRNA vaccine against RSV (respiratory syncytial virus) and a large pipeline of mRNA products against other infectious diseases, cancers and rare diseases, it is important to examine the whole product lifecycle. mRNA technology enables product design, testing and manufacturing systems to be rapidly developed, but these advantages can be lost if other factors that determine public access are not closely considered. This review analyzes key aspects of the mRNA product lifecycle including candidate design, manufacturing, quality systems and product safety and storage. Regulatory thinking is well advanced in some countries but not others, but more thought on the regulation of mRNA vaccines outside of a pandemic situation as well as mRNA therapeutics including individual neoantigen therapies and rare disease treatments is needed. Consumer acceptance-the "social license to operate" around mRNA products-is critical for their uptake, particularly outside of a pandemic.
随着几种针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的信使核糖核酸（mRNA）疫苗的成功部署、一种针对呼吸道合胞病毒（RSV）的mRNA疫苗以及大量针对其他传染病、癌症和罕见病的mRNA产品进入研发阶段，审视整个产品生命周期至关重要。mRNA技术能够使产品设计、测试和制造系统迅速得到开发，但如果不仔细考虑决定公众可及性的其他因素，这些优势可能会丧失。本综述分析了mRNA产品生命周期的关键方面，包括候选药物设计、制造、质量体系以及产品安全性和储存。一些国家的监管思路较为先进，而其他国家则不然，但对于大流行情况之外的mRNA疫苗以及包括个体化新抗原疗法和罕见病治疗在内的mRNA疗法的监管，还需要更多思考。消费者接受度——围绕mRNA产品的“运营社会许可”——对于其推广应用至关重要，尤其是在大流行情况之外。
