Purpose

The pace of the COVID-19 vaccine development process is unprecedented and is challenging the traditional paradigm of vaccinology science. The main pressure comes from the pandemic situation, but what makes it possible is a complex set of factors and innovative environments built along the times, which this manuscript aims to study.

Methods

Through an exploratory study within the scope of innovation management, the present manuscript aims to identify and explore factors that are promoting this accelerated development scenario. The method comprises the monitoring of the strategies adopted by the developers and other stakeholders, as regulatory and humanitarian agencies, specific mechanisms from governments and non-governments bodies, and the background technology that has paved this pathway.

Results

Technology-based and R&D strategy factors are the two main factors identified and explored herein. The breakthrough in the field of biotechnology and molecular biology is considered the main base-science that enables the rapid development of new vaccines. Additionally, new technological platforms can also be pointed out. Relating to R&D strategies, the parallelism of phases and adaptive clinical trials in consonance with regulatory agencies are the most relevant.

Conclusions

The need to rapidly develop a vaccine against COVID-19 occurs at a time of great excitement in basic scientific understanding, as well as strategies learned in the past by industry and optimization of regulatory pathways. It is expected that these factors, arising from the global emergency, may redirect the R&D processes for new drugs, especially in times of pandemic.

中文翻译：

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COVID-19 疫苗开发过程分析：加速因素和创新环境的探索性研究

目的

COVID-19 疫苗开发过程的步伐是前所未有的，正在挑战疫苗学的传统范式。主要压力来自大流行情况，但使之成为可能的是一系列复杂的因素和与时俱进的创新环境，这是本手稿旨在研究的。

方法

通过在创新管理范围内的探索性研究，本手稿旨在识别和探索促进这种加速发展情景的因素。该方法包括监测开发商和其他利益相关者（作为监管和人道主义机构）采用的策略、政府和非政府机构的具体机制，以及为这条道路铺平道路的背景技术。

结果

基于技术的因素和研发战略因素是本文确定和探索的两个主要因素。生物技术和分子生物学领域的突破被认为是能够快速开发新疫苗的主要基础科学。此外，还可以指出新的技术平台。与研发战略相关，阶段的平行性和与监管机构一致的适应性临床试验是最相关的。

结论

快速开发针对 COVID-19 的疫苗的需求发生在对基础科学理解以及行业过去学到的策略和监管途径优化感到非常兴奋的时候。预计这些由全球紧急情况引起的因素可能会改变新药的研发过程，尤其是在大流行时期。