Putter Jeffrey S
Medical Biomechanics Inc., San Diego County, CA, United States.
Transfus Apher Sci. 2021 Apr;60(2):103093. doi: 10.1016/j.transci.2021.103093. Epub 2021 Feb 13.
This review on COVID-19 immunotherapy enables a comparative analysis of the short-list of currently approved major vaccines. These include the Pfizer and Moderna first mRNA vaccines under FDA purview and the Oxford/AstraZeneca simian adenovirus-vectored vaccine (under UK-MHPRA guidance), all produced in record time, being safe and effective. The Pfizer and Moderna double dose vaccines have the clear edge in treatment efficacy, being in the 90% range compared to AstraZeneca in the average 70%. However, the AZ double dose vaccine has significant advantages with respect to lower cost and stability in storage. We enumerate several potential advances in the technology of the manufacturers: (1) combination vaccines such as testing AstraZeneca's product with a component of the Russian's Sputnik V to achieve durable immunity; (2) the potential for single dose vaccines coming on-line, and with Johnson & Johnson/Janssen; and (3) the need for refined thermotolerant formulations obviating the need for cold storage. As an adjunct to vaccinotherapy, affinity adsorption column technology is another facet recruited in the processing of corona convalescent plasma/cryosupernatant to concentrate neutralizing antibodies against the virus. Clinical trials, to date, of infected patients have been indeterminate as to whether plasmapheresis-based products are effective or not. This is due to the failure to standardize the composition of the plasma derived component, ambiguous clinical indications for use in human subjects, and inconsistent timing of administration in the course of the infection. Known T-cell lymphopenia, which is attendant to progressive viral infection and immune driven inflammation, may be a quantitative surrogate biological marker as to when to start treatment. This is not only for initiating plasmapheresis-based therapeutics but also the judicious selection of ancillary pharmaceuticals, ie. monoclonal antibodies, recombinant proteins and anti-viral drugs.
这篇关于新冠病毒免疫疗法的综述对目前获批的主要疫苗清单进行了比较分析。这些疫苗包括美国食品药品监督管理局(FDA)管辖下的辉瑞和莫德纳首批mRNA疫苗,以及牛津大学/阿斯利康的猿猴腺病毒载体疫苗(在英国药品和保健品管理局(UK-MHPRA)的指导下),所有这些疫苗均在创纪录的时间内生产出来,安全且有效。辉瑞和莫德纳的双剂量疫苗在治疗效果上具有明显优势,平均有效率在90%左右,而阿斯利康的平均有效率为70%。然而,阿斯利康的双剂量疫苗在成本较低和储存稳定性方面具有显著优势。我们列举了制造商技术方面的几个潜在进展:(1)联合疫苗,如将阿斯利康的产品与俄罗斯卫星V疫苗的一种成分进行测试,以实现持久免疫;(2)单剂量疫苗上线的可能性,如强生公司/杨森公司生产的疫苗;(3)需要改进耐热配方,从而无需冷藏。作为疫苗治疗的辅助手段,亲和吸附柱技术是在处理新冠康复期血浆/冷冻上清液以浓缩针对该病毒的中和抗体过程中采用的另一个方面。迄今为止,针对感染患者的临床试验对于基于血浆置换的产品是否有效尚无定论。这是由于未能规范血浆衍生成分的组成、在人体受试者中使用的临床适应症不明确以及在感染过程中给药时间不一致。已知进行性病毒感染和免疫驱动炎症伴随的T细胞淋巴细胞减少可能是何时开始治疗的一个定量替代生物标志物。这不仅适用于启动基于血浆置换的治疗,也适用于明智地选择辅助药物,即单克隆抗体、重组蛋白和抗病毒药物。