2019冠状病毒病对疫苗开发模式的影响

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摘要

疫苗是有效预防传染病的预防性医疗产品。虽然在临床前阶段进行了大量的疫苗研究,但批准的疫苗数量不到10%。疫苗的开发从研究阶段到行政机构的批准通常需要5到10年的时间。然而,在突发公共卫生事件期间,这段疫苗开发时间并不方便,因为需要在短时间内开发出有效的疫苗,以限制高死亡率和发病率的速度。由严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)引起的2019冠状病毒病(COVID-19)大流行迅速在全球造成了灾难性影响。因此,COVID-19疫苗的开发遵循了一个非典型过程。为了开发有效的疫苗,政府机构、学术界、医疗企业之间的合作付出了巨大的努力,并投入了大量预算。截至2023年3月,临床和临床前开发的COVID-19疫苗数量分别为183个和199个。实施了紧急使用授权(EUA)程序,以加快疫苗的批准。因此,疫苗接种可以在不到一年的时间内开始,从而减缓了大流行的速度。虽然EUA引起了一些人对疫苗的安全性和有效性的质疑,但绝大多数人都接种了疫苗。目前,超过55亿人(约占世界人口的70%)接种了11种不同的COVID-19疫苗133.8亿剂,其中73%的剂量是辉瑞/BioNTech公司生产的Comirnaty疫苗。
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Effect of coronavirus disease 2019 on the vaccine development paradigm
Vaccines are prophylactic medical products effectively used against infectious diseases. Although a high amount of vaccine studies are conducted at the preclinical stage, the number of approved vaccines is less than 10%. Development of vaccines from the research stage to the approval of administrative institutions takes about 5 years to 10 years conventionally. However, this period of time for vaccine development is not convenient during public health emergencies because an effective vaccine is required in a short time to restrict the speed of high mortality and morbidity. The pandemic of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), had its catastrophic effects worldwide quickly. Therefore, an atypical process was followed for the development of COVID-19 vaccines. Great effort was spent in terms of cooperation among the governmental institutions, academia, and medical companies as well as a high amount of budget was allocated to develop effective vaccines against COVID-19. As of March 2023, the numbers of COVID-19 vaccines in clinical and preclinical development were 183 and 199, respectively. An emergency use authorization (EUA) process was applied to accelerate the approval of the vaccines. Consequently, vaccinations could be started in less than a year, which decelerated the speed of the pandemic. Although EUA caused hesitancy among some people questioning the safety and efficacy of the vaccines, the vast majority of the population was vaccinated. Currently, more than 5.5 billion people (about 70% of the world population) have received 13.38 billion doses of 11 different COVID-19 vaccines, and 73% of the doses were Comirnaty manufactured by Pfizer/BioNTech.
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