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

Abstract

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.

Keywords: COVID-19; Innovation management; Product development process; Vaccine.

Fig. 1

Overview of vaccine development for COVID-19 in the last ten months (Note: data collection date related to the corresponding total number of vaccines under development and those in clinical development, respectively: 1. 02/18/2020 (21/0); 2. 05/27/2020 (125/10) 3. 08/31/2020 (176/33) and 12/08/2020 (214/51*). Figure based on documents found at the WHO website: DRAFT landscape of COVID-19 candidate vaccines [5]. *One candidate vaccine included in the WHO list was not considered in this study due the lack of information.)

Fig. 2

Schematic presentation of the methodology applied to the study. Source: created by the authors (Lucidchart®)

Fig. 3

Distribution of COVID-19 candidate vaccine clinical trials among phases

Fig. 4

Distribution of the COVID-19 candidate vaccine developers based on the country of origin

Fig. 5

Distribution of the recruiting countries based on the COVID-19 candidate vaccine clinical trials

Fig. 6

Route of administration studied in the COVID-19 candidate vaccines under clinical development

Fig. 7

Parallelism of clinical phases (most advanced COVID-19 candidate vaccines). Source: Created by the authors (Lucidchart®)