SARS-CoV-2 vaccines: fast track versus efficacy.
SARS-CoV-2 vaccines: fast track versus efficacy.
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DOI：
10.1016/s2666-5247(21)00034-3
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发表时间：
2021-03
期刊：
影响因子：
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通讯作者：
Panagiotou S
中科院分区：
文献类型：
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作者：
Alkandari D;Herbert JA;Alkhalaf MA;Yates C;Panagiotou S
根据世卫组织的数据，截至2021年2月2日，全球新冠肺炎病例已超过1.03亿例，死亡人数超过220万人。疫苗已经成为解决方案的同义词，而针对SARS-CoV-2病毒-导致新冠肺炎的病毒-的疫苗是应对这场流行病的唯一解决方案，以避免进一步的大规模伤亡。几种领跑者SARS-CoV-2疫苗已经在国家获得批准，超过了平均许可和批准速度的五倍。1现在已经接种了超过1亿剂SARS-CoV-2疫苗，尽管全球新冠肺炎大流行的影响已经是巨大的，但人们对疫苗的安全性仍然犹豫不决。这些担忧不可避免地与快速的开发、生产和审批速度有关。批准的SARS-CoV-2疫苗基于新的疫苗技术。核酸疫苗(RNA或DNA)依靠宿主细胞产生所需的蛋白质疫苗抗原，而不是像传统疫苗那样直接提纯和输送抗原。核酸疫苗组分比纯化抗原更容易产生，这已经成为快速追踪SARS-CoV-2疫苗的重要因素。例如，一种减毒活轮状病毒疫苗需要16年才能获得许可，2一种重组蛋白脑膜炎双球菌疫苗需要7年才能获得许可。3在SARS-CoV-2疫苗之前，没有核酸平台被许可用于传染病，这一平台在个性化肿瘤疫苗中的成功应用促进了SARS-CoV-2疫苗的快速发展。4随着基于信使核糖核酸的疫苗显示出高中和效价，5与使用传统疫苗技术开发的疫苗的效价相似，很明显，我们正在进入疫苗设计的新时代。由于新冠肺炎大流行的破坏性影响和减轻其影响的紧迫性，关键的疫苗开发过程仍在进行中。4期试验(尽管不需要获得许可)并没有被领先的制药公司优先考虑：关于长期安全性和罕见不良反应的数据实际上是在疫苗接种人群中收集的。在德国，接种疫苗与老年人死亡之间的潜在联系突显了4期试验的重要性。
According to WHO, as of Feb 2, 2021, global cases of COVID-19 have surpassed 103 million, and deaths exceed 2· 2 million. The word vaccine has become synonymous to the word solution, and vaccines against SARS-CoV-2—the virus that causes COVID-19—are the only solution to this pandemic, to avoid further mass casualties. Several frontrunner SARS-CoV-2 vaccines are already approved in 64 countries, surpassing the average pace of licensure and approval fivefold. 1 More than 100 million doses of a SARS-CoV-2 vaccine have now been administered, and although the effect of the global COVID-19 pandemic has been vast, there is still hesitation about vaccine safety. These concerns are irrevocably associated with the rapid pace of development, production, and approvals. Approved SARS-CoV-2 vaccines are based on novel vaccine technologies. Nucleic acid vaccines (either RNA or DNA) rely on host cells to produce the desired protein vaccine antigen, instead of the antigen being purified and delivered directly, as in a traditional vaccine. Nucleic acid vaccine components are much easier to generate than are purified antigens, which has been an important element to fast-tracking SARS-CoV-2 vaccines. For example, a live-attenuated rotavirus vaccine took 16 years to be licensed, 2 and a recombinant protein meningococcal group B vaccine took 7 years to reach licensure. 3 Before the SARS-CoV-2 vaccines, no nucleic acid platforms were licensed for infectious diseases, and rapid progression of the SARS-CoV-2 vaccines was assisted by the successful use of this platform in personalised oncology vaccines. 4 With mRNA-based vaccines showing high neutralising titres, 5 similar to titres of vaccines developed using traditional vaccine technologies, it is clear that we are entering a new era of vaccine design.Because of the devastating effects of the COVID-19 pandemic and the urgency to alleviate its impact, key vaccine development processes are still ongoing. Phase 4 trials (although not needed for licensure) have not been prioritised by the leading pharmaceutical companies: data for long-term safety and rare adverse reactions are, in effect, being gathered within the vaccinated population. The importance of phase 4 trials has been underlined by the potential link between vaccination and deaths of elderly individuals in Germany