Industrial Scale Production of the R21c/Matrix-M Malaria Vaccine for Sub-Saharan Africa; Impact of Vaccine Inequity on Developing Countries

Lucas, Ian, School of Engineering and Applied Science, University of Virginia
Earle, Joshua, Engineering and Society, University of Virginia
Anderson, Eric, Chemical Engineering, University of Virginia

Vaccine Inequity is the term for the disparity in drug distribution, which has a significant negative effect on poor countries. Vaccine inequality prevents low- and middle-income nations from being able to offer their citizens the best protection possible against illnesses, even if medicines have been around for a long time. Due to the uneven distribution of vaccinations across the world during the COVID-19 pandemic, people became more aware of vaccine equity and its effects. The pandemic demonstrated that in order to end vaccine disparity, high-income countries and pharmaceutical corporations must cooperate to supply vaccinations to low-income countries.
Actor-network theory will be utilized to understand how different actors shape the distribution and availability of vaccines in developing countries. Access to vaccinations may be hampered by non-human actors such as inadequate financing for vaccine research and development and inadequate infrastructure for vaccine distribution. In addition, human actors like governments, pharmaceutical firms, and international organizations have a big say in who gets access to vaccinations and who doesn't. We may better comprehend how these different players interact with and affect one another to produce the current climate of vaccination inequality by using an ANT perspective.
For my STS study, I examined the effects of vaccination inequality on developing countries and the causes of these inequalities. This started with research into the worldwide history of vaccinations and medicine, which revealed that these disparities had existed for centuries. The causes of current vaccination inequities were discovered by examining the manufacture and distribution of medical products across history. There are distinct social and economic effects on residents in poorer nations as a result of the unequal distribution of vaccines.
The World Health Organization, the United Nations, and COVAX provided information on the COVID-19 pandemic, which was principally collected and analyzed for this study. By observing the cases and fatalities resulting from vaccine inequity and considering the economic burden that wealthier nations can bear to end this practice, I developed some frameworks that can potentially mitigate the impact of existing diseases like malaria or HIV. These frameworks are based on the existing infrastructure in regions like Africa that facilitate vaccine distribution, as well as the approaches used by organizations like UNICEF to manage malaria. Issues displayed throughout the history of vaccine inequity and its effects during the pandemic informed the development of these structures. The purpose of this study is to better understand vaccination inequities on a global scale.
For my technical report, my team and I designed an industrial-scale production facility for the R21c/Matrix-M malaria vaccine, which was developed by Oxford and is currently undergoing clinical trials. This vaccine has demonstrated an impressive 80 percent efficacy rate, which is more than double the efficacy of the existing malaria vaccine that falls short of the WHO's efficacy goal of 75 percent. Since malaria is a major health concern in sub-Saharan Africa, particularly for adolescents, our production facility aims to manufacture enough vaccines to inoculate 70 percent of newborns and 20 percent of children under 5 years of age.
The goal of this project is to develop an affordable process for producing single-dose R21/Matrix-M vaccines to prevent malaria infections in Sub-Saharan Africa, in anticipation of vaccine approval. The process involves several stages at an industrial scale, including upstream, downstream, formulation, and fill-finish. The upstream processing will involve batch fermentation with Pichia pastoris to produce R21. The downstream processing will involve lysing the yeast cells, purifying the CSP fusion proteins, and filtering out impurities. For formulation and fill-finish, the R21 protein particle will be mixed with Matrix-M obtained from Novavax, resulting in the final product. The project will conclude with an analysis of economic feasibility.

BS (Bachelor of Science)
Vaccine, Vaccine Inequity, Actor-Network Theory (ANT), Malaria, R21c

School of Engineering and Applied Science
Bachelor of Science in Chemical Engineering
Technical Advisor: Eric Anderson
STS Advisor: Joshua Earle
Technical Team Members: Sierra Giles, Anupama Jayaraman, Jacob Wilkins, William Wonsik

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