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军事科学院军事医学研究院微生物流行病研究所,病原微生物生物安全全国重点实验室,北京 100071
Received:07 October 2023,
Revised:2024-01-29,
Published:30 April 2024
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叶青, 秦成峰. “国际公共卫生紧急事件”下的mRNA疫苗研发[J]. 合成生物学, 2024, 5(2): 310-320
YE Qing, QIN Chengfeng. Development of mRNA vaccines in response to the Public Health Emergency of International Concern[J]. Synthetic Biology Journal, 2024, 5(2): 310-320
叶青, 秦成峰. “国际公共卫生紧急事件”下的mRNA疫苗研发[J]. 合成生物学, 2024, 5(2): 310-320 DOI: 10.12211/2096-8280.2023-072.
YE Qing, QIN Chengfeng. Development of mRNA vaccines in response to the Public Health Emergency of International Concern[J]. Synthetic Biology Journal, 2024, 5(2): 310-320 DOI: 10.12211/2096-8280.2023-072.
“国际公共卫生紧急事件”(简称PHEIC)是指疾病的国际传播对其他国家构成公共卫生风险,需要采取协调一致的国际应对措施的不同寻常事件。迄今为止,世界卫生组织(WHO)一共宣布了7次PHEIC,包括甲型H1N1流感、埃博拉、脊髓灰质炎、寨卡、新型冠状病毒感染和猴痘疫情。疫苗是应对传染病疫情的有力武器,合成生物学的发展突破了传统疫苗存在的难点问题和技术瓶颈,为病毒性传染病防控提供了全新的思路,尤其是mRNA疫苗作为下一代疫苗研发的平台技术,具有安全性强、有效性良好、研发周期短、易规模化生产、易扩大产能等特点,在应对新突发传染病疫情方面具有明显的优势。目前,新冠mRNA疫苗已正式获批上市,针对流感、寨卡和猴痘病毒的多款mRNA疫苗已进入临床研究阶段,埃博拉mRNA疫苗处于临床前研究阶段,而针对脊髓灰质炎病毒尚无mRNA疫苗研究的报道。本文就历次PHEIC应对中mRNA疫苗的研发进展进行了详细梳理和评述,同时对mRNA疫苗应对PHEIC的未来发展趋势和挑战进行了展望和讨论。结合合成生物学、生物化学和人工智能等多学科技术对mRNA分子设计、高效递送以及疫苗生产和储存运输等进行优化,有望进一步提高mRNA疫苗的有效性和可及性。综上,尽管尚无法预知下一次PHEIC何时会出现,但当下一次PHEIC出现时,mRNA疫苗技术一定会成为人类防范PHEIC的有力武器。
A Public Health Emergency of International Concern (PHEIC) is defined by the World Health Organization (WHO) as “an extraordinary event which is determined to constitute a public health risk to other states through the international spread of disease and potentially requires a coordinated international response”. To date
WHO has declared seven PHEIC events
including the H1N1 influenza
Ebola
poliomyelitis
Zika
COVID-19 and mpox. Vaccination remains as an effective method in preventing infectious diseases. The International Health Regulations (IHR) Emergency Committee's recommendations for preventing or reducing the international spread of disease and avoiding unnecessary interference with international traffic include an emphases on the development of diagnostics and therapeutics for diseases
as well as the vaccine development. The mRNA vaccine represents a platform technology for the development of next-generation vaccines
and possesses distinct advantages
such as a shortened development cycle
scalable and cost-effective production
as well as enhanced amplification capacity
highlighting its potential in rapid responding to emerging and re-emerging infectious diseases. In recent decades
the development of mRNA synthesis technology and nucleic acid delivery system has facilitated the rapid development of mRNA vaccines and their clinical applications. Here
we overview the development of mRNA vaccines in response to the past PHEICs
and discuss challenges and trends in this regard. Currently
COVID-19 mRNA vaccines have been authorized for human use
while multiple mRNA vaccines against influenza
Zika
mpox and Ebola have been evaluated in clinical or pre-clinical studies. Despite their proven efficacy
there is still room for further improvement of the mRNA vaccines. The mRNA design
optimization
delivery
formulation
manufacturing
storage
and transportation can be further improved by integrating synthetic biology
biochemistry
artificial intelligence
and other multidisciplinary technologies. Although the emergence of the next PHEIC cannot be predicted with certainty
we are optimistic that the mRNA vaccine technology will play a pivotal role in preventing pandemics in the future.
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