University of Paris-Cité, Paris, France.
Programme for Global Health, Royal Institute of International Affairs, Chatham House, London, UK.
Hum Vaccin Immunother. 2023 Dec 31;19(1):2209000. doi: 10.1080/21645515.2023.2209000.
New technologies for the prevention of infectious diseases are emerging to address unmet medical needs, in particular, the use of long-acting monoclonal antibodies (mAb) to prevent Respiratory Syncytial Virus (RSV) lower respiratory tract disease in infants during their first RSV season. The lack of precedent for mAbs for broad population protection creates challenges in the assessment of upcoming prophylactic long-acting mAbs for RSV, with associated consequences in legislative and registration categorization, as well as in recommendation, funding, and implementation pathways. We suggest that the legislative and regulatory categorization of preventative solutions should be decided by the effect of the product in terms of its impact on the population and health-care systems rather than by the technology used or its mechanism of action. Immunization can be passive and active, both having the same objective of prevention of infectious diseases. Long-acting prophylactic mAbs work as passive immunization, as such, their recommendations for use should fall under the remit of National Immunization Technical Advisory Groups or other relevant recommending bodies for inclusion into National Immunization Programs. Current regulations, policy, and legislative frameworks need to evolve to embrace such innovative preventative technologies and acknowledge them as one of key immunization and public health tools.
新的传染病预防技术正在涌现，以满足未满足的医疗需求，特别是使用长效单克隆抗体 (mAb) 预防婴儿在其第一个 RSV 季节中 RSV 下呼吸道疾病。由于缺乏针对广泛人群保护的 mAbs 的先例，因此在评估即将推出的预防长效 mAbs 预防 RSV 方面存在挑战，这对立法和注册分类以及建议、资金和实施途径都有影响。我们建议，预防性解决方案的立法和监管分类应根据产品对人群和医疗保健系统的影响来决定，而不是根据所使用的技术或其作用机制。免疫可以是被动的，也可以是主动的，两者都有预防传染病的相同目标。长效预防性 mAb 作为被动免疫起作用，因此，它们的使用建议应属于国家免疫技术咨询小组或其他相关推荐机构的职权范围，以将其纳入国家免疫规划。当前的法规、政策和立法框架需要发展，以接纳此类创新的预防技术，并将其视为关键的免疫和公共卫生工具之一。
