Dr Pia Steigler
The Bill and Melinda Gates Foundation
TB vaccine development: Considerations for production in low-and middle-income countries
Poster Abstract
Pia Steigler, Gerhardt Boukes, Munyaradzi Musvosvi, Kristie Bloom, Thomas J Scriba, Michelle Fisher, Abdullah Ely, Muazzam Jacobs, Patrick Arbuthnot, Amin Khan, Caryn Fenner and Petro Terblanche
Tuberculosis (TB) is one of the oldest and deadliest infectious disease. Yet, progress in TB vaccine development has beer1 slow, which can be ascribed to the complexity of the disease and low commercial attractiveness. The recent Covid-19 pandemic surfaced the global inequity in vaccine access between high-and low-to middle-income countries, with one key bottleneck being the lack of manufacturi11g facilities in low-and middle-income countries {LMICs). With the breakthrough in mRNA technology, a suitable alternative to conventional vaccine manufacturing was found, allowing LMICs to produce vaccines in resource limited settings. The initiation of the mRNA Technology Transfer Hub by the World Health Organization at Afrigen Biologics in South Africa, lead to the establishment of Africa's first end-to-end mRNA vaccine development and GMP manufacturing facility. After bearir1g many challenges suc1 as securing affordable raw materials, navigatir1g intellectual property issues, and a lack of local regulatory experiences, Afriger1 successfully established a platform to produce Africa's first TB mRNA.
Strong collaborations between Afrigen, the SAM RC and the academic sector in South Africa, including the Universities of Cape Town and Witwatersrand, led to the development a TB mRNA vaccine candidate. To ensure the affordability of the vaccine product, four Mycobacterium tuberculosis (Mtb) antigens were designed to be expressed as a polypeptide. In vitro transcription will be performed with an autornated n1RNA system to further reduce cost and production time. Establishing local vaccine manufacturing capacities in LMICs is imperative to target neglected diseases, ensuring equitable vaccine access and pandemic preparedness. Thoughtful planning during early stages of vaccine development is essential to ensure sustainable delivery of live saving vaccines in LMICs. Future research in modified nucleotides, novel lipid formulations, and lyophilization techr1ologies (thermostability) will be conducted to drive the generation of an affordable next generation TB mRNA vaccine.
