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. 2021 Apr 3;17(4):1122-1127.
doi: 10.1080/21645515.2020.1822136. Epub 2020 Sep 29.

COVID-19 vaccine development during pandemic: gap analysis, opportunities, and impact on future emerging infectious disease development strategies

Shyam Rele  1
Affiliations

COVID-19 vaccine development during pandemic: gap analysis, opportunities, and impact on future emerging infectious disease development strategies

Shyam Rele. Hum Vaccin Immunother. .

Abstract

The world remains cautiously optimistic about a COVID-19 vaccine that is relatively safe and efficacious and that offers sufficient long-lasting protection/immunity by neutralizing the virus infectivity. However, key technical hurdles pertaining to antigen-adjuvant formulation, delivery, and manufacturing challenges of lipid nanoparticles (LNPs) for mRNA vaccines and stability of formulations need to be addressed for successful product development and stockpiling. In addition, the dosage form, the dosage level and regimen for eliciting a protective immune response remain to be established. The high dependence of global supply chains and demand-supply to sourcing quality raw materials, glassware and other supplies, along with the stress on existing production capacities and platform-specific manufacturing challenges could impede vaccine development and access. This article provides critical analysis of vaccine development processes and unit operations that can derail the pandemic response, and also extends to other emerging infectious disease development efforts - issues that take on added significance given the global mandate for an accelerated and at-risk development path to tackle the COVID-19 pandemic.

Keywords: COVID; GMP manufacturing; adjuvants; immune response; mRNA-lipid nanoparticle; supply chains; vaccine dose; vaccines.

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Figures

Figure 1.
Figure 1.
Schematic comparing typical vaccine development process paradigm with potential expedited manufacturing at risk for pandemics. The current vaccine categories are: (i) inactivated virus, (ii) replicating and non-replicating viral vectors, (iii) nucleic acid vaccine (DNA and mRNA), (iv) recombinant protein vaccines and (v) virus like particles. [A] Traditional vaccine development pathway and activities; [B] Traditional vaccine development pathway to licensure; [C] Pandemic Paradigm: Overlapping phases and shortening development time. (Figure not as per time scale)
See this image and copyright information in PMC

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