Medigen Vaccine Biologics Corp., Taipei, Taiwan.
Medigen Vaccine Biologics Corp., Taipei, Taiwan; Institute of Public Health, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Vaccine. 2023 Apr 6;41(15):2615-2629. doi: 10.1016/j.vaccine.2023.02.083. Epub 2023 Mar 3.
The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit-risk assessment of several vaccine platform technologies, including protein subunit vaccines. This article uses the BRAVATO template to review the features of the MVC-COV1901 vaccine, a recombinant protein subunit vaccine based on the stabilized pre-fusion SARS-CoV-2 spike protein S-2P, adjuvanted with CpG 1018 and aluminum hydroxide, manufactured by Medigen Vaccine Biologics Corporation in Taiwan. MVC-COV1901 vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The template offers details on basic vaccine information, target pathogen and population, characteristics of antigen and adjuvant, preclinical data, human safety and efficacy data, and overall benefit-risk assessment. The clinical development program began in September 2020 and based on demonstration of favorable safety and immunogenicity profiles in 11 clinical trials in over 5,000 participants, it has been approved for emergency use based on immunobridging results for adults in Taiwan, Estwatini, Somaliland, and Paraguay. The main clinical trials include placebo-controlled phase 2 studies in healthy adults (CT-COV-21), adolescents (CT-COV-22), and elderly population (CT-COV-23) as well as 3 immunobridging phase 3 trials (CT-COV-31, CT-COV-32, and CT-COV-34) in which MVC-COV1901 was compared to AZD1222. There are also clinical trials studying MVC-COV1901 as homologous and heterologous boosters (CT-COV-24 and CT-COV-25). The totality of evidence based on ∼3 million vaccinees to date includes a mostly clean safety profile, with adverse events mostly being mild and self-limiting in both clinical development and post-marketing experience, proven immunogenic response, and real-world effectiveness data. The immunogenic profile demonstrates that MVC-COV1901 induces high levels of neutralizing and binding antibodies against SARS-CoV-2. There is a dose-dependent response and a significant correlation between binding and neutralizing antibody activity. Antigen-specific T-cell responses, particularly a Th1-biased immune response characterized by high levels of interferon gamma and IL-2 cytokines, have also been observed. Coupled with this, MVC-COV1901 has favorable thermostability and better safety profiles when compared to other authorized vaccines from different platforms, which make it potentially a good candidate for vaccine supply chains in global markets.
布莱顿合作组织疫苗风险获益评估（BRAVATO）工作组已制定了标准化模板，用于描述包括蛋白亚单位疫苗在内的几种疫苗平台技术的风险获益评估的关键考虑因素。本文使用 BRAVATO 模板来回顾 Medigen Vaccine Biologics 公司研发的基于稳定的 SARS-CoV-2 刺突蛋白 S-2P 的重组蛋白亚单位疫苗 MVC-COV1901 的特点，该疫苗佐剂为 CpG 1018 和氢氧化铝。MVC-COV1901 疫苗适用于预防 12 岁及以上个体由 SARS-CoV-2 引起的 COVID-19。该模板提供了有关基本疫苗信息、目标病原体和人群、抗原和佐剂特征、临床前数据、人体安全性和疗效数据以及总体风险获益评估的详细信息。该临床开发计划于 2020 年 9 月开始，在超过 5000 名参与者的 11 项临床试验中证明了良好的安全性和免疫原性，根据台湾、埃斯瓦蒂尼、索马里兰和巴拉圭成年人的免疫桥接结果，该疫苗已被批准紧急使用。主要临床试验包括健康成年人（CT-COV-21）、青少年（CT-COV-22）和老年人群（CT-COV-23）的安慰剂对照 2 期研究，以及 3 项免疫桥接 3 期试验（CT-COV-31、CT-COV-32 和 CT-COV-34），其中 MVC-COV1901 与 AZD1222 进行了比较。还有研究 MVC-COV1901 作为同源和异源加强针的临床试验（CT-COV-24 和 CT-COV-25）。基于迄今为止约 300 万疫苗接种者的总体证据，安全性概况基本良好，在临床开发和上市后经验中，不良反应大多为轻度和自限性，具有免疫原性应答和真实世界有效性数据。免疫原性特征表明，MVC-COV1901 可诱导针对 SARS-CoV-2 的高水平中和和结合抗体。存在剂量依赖性反应，并且结合抗体活性与中和抗体活性之间存在显著相关性。还观察到抗原特异性 T 细胞反应，特别是以高水平干扰素γ和 IL-2 细胞因子为特征的 Th1 偏向性免疫反应。此外，与其他来自不同平台的已授权疫苗相比，MVC-COV1901 具有更好的热稳定性和安全性，这使其成为全球市场疫苗供应链的潜在良好候选者。
