Buoninfante Alessandra, Cavaleri Marco
Public Health Threats Department, European Medicines Agency, Amsterdam, Netherlands.
Front Immunol. 2025 Jun 12;16:1584738. doi: 10.3389/fimmu.2025.1584738. eCollection 2025.
Vaccines are complex biological medicinal products developed with the aim to generate protective immunity against specific infectious diseases in a particular target population. Regulatory authorities, who have the role of approving vaccines, ensure that these meet the agreed criteria for quality, safety and efficacy, and assess their benefit and risk profile before and after a marketing authorization is granted. In the European Union/European Economic Area, the vast majority of the vaccines currently available has been approved on the basis of clinical efficacy or immunogenicity data relying on humoral immune responses. Per contrary, there are no vaccines approved based on immunogenicity endpoints exclusively focused on cell mediated immunity, despite the known relevance of T cells immunity for protection against a variety of infectious diseases. We here review a few relevant cases of vaccines targeting infectious diseases for which data on cell mediated immunity have been considered in the context of regulatory filing, and provide our perspective on the way forward.
疫苗是复杂的生物药品,其研发目的是在特定目标人群中产生针对特定传染病的保护性免疫。负责批准疫苗的监管机构确保这些疫苗符合商定的质量、安全和有效性标准,并在授予上市许可前后评估其益处和风险概况。在欧盟/欧洲经济区,目前可用的绝大多数疫苗是根据依赖体液免疫反应的临床疗效或免疫原性数据批准的。相反,尽管已知T细胞免疫对预防多种传染病具有相关性,但尚无仅基于专门针对细胞介导免疫的免疫原性终点批准的疫苗。我们在此回顾一些针对传染病的疫苗的相关案例,在这些案例中,细胞介导免疫的数据已在监管申报的背景下得到考虑,并就未来的发展方向提供我们的观点。
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