Vaccine Dynamics, Easton, MD, USA.
Coalition for Epidemic Preparedness & Innovation, Oslo, Norway.
Expert Rev Vaccines. 2024 Jan-Dec;23(1):796-811. doi: 10.1080/14760584.2024.2397006. Epub 2024 Sep 1.
Global outbreaks involving mpox clade IIb began in mid-2022. Today, clade IIb and clade I outbreaks continue. Reliable mpox vaccines can prevent serious mpox disease and death.
Globally, two vaccines hold mpox indications, regardless of mpox viral clade: MVA-BN (Bavarian Nordic) and LC16m8 (KM Biologics). This review summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through 2024.
Some regulatory decisions for MVA-BN and LC16m8 followed pathways based on surrogate outcomes, including lethal-challenge studies in nonhuman primates, among other atypical aspects. Nonetheless, MVA-BN and LC16m8 hold unencumbered registration in multiple countries. Effectiveness of MVA-BN as primary preventive vaccination (PPV) in humans against clade IIb mpox is clear from real-world studies; effectiveness of LC16m8 against clade IIb is likely from surrogate endpoints. Effectiveness of MVA-BN and LC16m8 as PPV against more-lethal clade I is likely, based on animal-challenge studies with multiple orthopoxvirus species and other studies. Both vaccines have solid safety records. MVA-BN's replication incompetence favors adoption, whereas LC16m8 has more pediatric data. Additional real-world evidence, in additional geographic settings and special populations (e.g. pregnancy, immune suppression, atopic dermatitis), is needed.
涉及 mpox 分支 IIb 的全球疫情于 2022 年年中开始。如今，分支 IIb 和分支 I 的疫情仍在继续。可靠的 mpox 疫苗可以预防严重的 mpox 疾病和死亡。
在全球范围内，有两种疫苗针对 mpox 病毒的不同分支，均获得了 mpox 疫苗的上市许可：MVA-BN（巴伐利亚北欧公司）和 LC16m8（KM 生物制品公司）。本综述总结了 MVA-BN 和 LC16m8 的人体和关键动物数据，这些数据确立了它们的安全性和有效性，包括 2022 年至 2024 年期间在 mpox 疫情期间收集的真实世界证据。
MVA-BN 和 LC16m8 的一些监管决策遵循基于替代终点的途径，包括非人类灵长类动物的致死性挑战研究等非典型方面。尽管如此，MVA-BN 和 LC16m8 在多个国家仍不受限制地注册。从真实世界研究中可以清楚地看到 MVA-BN 作为针对分支 IIb mpox 的人类初级预防接种（PPV）的有效性；LC16m8 针对分支 IIb 的有效性可能来自替代终点。基于对多种正痘病毒属物种和其他研究的动物挑战研究，MVA-BN 和 LC16m8 作为针对致死性更高的分支 I 的 PPV 的有效性可能是合理的。这两种疫苗都有可靠的安全性记录。MVA-BN 的复制无能有利于采用，而 LC16m8 则有更多的儿科数据。需要在其他地理环境和特殊人群（如妊娠、免疫抑制、特应性皮炎）中获得更多的真实世界证据。
