Analysis of the COVID-19 Vaccine Development Process: an Exploratory Study of Accelerating Factors and Innovative Environments

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 ti...

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Bibliographic Details
Published in:	Journal of pharmaceutical innovation Vol. 17; no. 2; pp. 555 - 571
Main Authors:	Defendi, Hugo Garcia Tonioli, da Silva Madeira, Luciana, Borschiver, Suzana
Format:	Journal Article
Language:	English
Published:	New York Springer US 02-02-2021
Subjects:	Biochemical Engineering Biomedical and Life Sciences Biomedicine Biotechnology Industrial and Production Engineering Original Original Article Pharmacology/Toxicology COVID-19 Innovation management Vaccine Product development process
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1872-5120 1939-8042
DOI:	10.1007/s12247-021-09535-8