SESSION ONE: Drug Substance Development & Manufacturing Processes Dr Simon Agwale: Dr Agwale indicated that he would be sharing his experience from the last 15 years of producing vaccine candidates for the unique diseases that affect the African continent. According to recent announcements, Africa currently has facilities that can produce 4.5 billion doses of vaccines per annum (referring to the finished product); the question is how we feed these facilities (with active drug substance, which is currently mostly being imported). The goal is to have Africa produce 60% of its own vaccines by 2040 (African CDC target); which translates to 1.5 billion doses per annum. Therefore, there are major plans to put facilities on the ground. In terms of distribution, in South Africa alone there are four major initiatives: Aspen aims to produce 500 million doses per annum, NAT SA will be producing one billion doses per annum, Afrigen’s target is 250 million doses per annum and Biovac aims to produce 100 million doses per annum. Morocco aims to produce 500 million doses, Egypt is targeting 300 million doses and Senegal is aiming for 250 million doses per annum. This demonstrates that Africa has the capacity to fill-finish 4.5 billion doses per annum. The key question is where the drug substance will come from; the business case needs to be considered. Dr Agwale went on to stress the importance of choosing which vaccine platform the continent will use. He shared how the arrival of COVID-19 catalysed the building of vaccine manufacturing facilities in Nigeria; his team is currently in the process of developing a second-generation vaccine for COVID-19. He added that to build a vaccine production facility, a process is required; without the process, the development of a vaccine cannot be designed. For this industry to thrive and be sustainable, one should not only look at the availability of vaccines but the business case and then build infrastructure based on the products that will help to sustain the industry; he however noted that a pandemic situation may require a different approach. The production of the product/
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vaccine must sustain the facility; there must be a market/demand for the vaccine, and the venture must be viable and relevant. Dr Agwale then went on the share his experience in developing an HBV vaccine which will provide more protection/coverage for people living in Africa (more impactful), at a reduced cost (cheaper). He concluded by reiterating that there should be justification for going into a venture; we need to carefully look at what exists and what the gaps are, and then try to produce vaccines that will fill those gaps. Dr Agwale also shared that a critical consideration when building a business case is consulting financial experts who can do the modelling to see whether the venture is profitable. Investors will want to see that the business case is viable. Prof Petro Terblanche: Prof Terblanche indicated that she would share Afrigen’s experience in creating an mRNA vaccine and what it took to make this process successful; a case study that provides both learnings and is aligned to a strategy of drug substance manufacturing. The African continent currently produces one per cent of the vaccines it uses/needs and uses 25% of the vaccines produced globally. Pre-2020 there was very little capacity on the continent for drug substance production and insufficient capacity for fill-finish. Prof Terblanche reiterated Dr Agwale’s question – the African continent is currently over-capacitated in terms of fill-finish; how do we feed this? Prof Terblanche shared that Afrigen developed an end-to-end vaccine manufacturing facility without a business plan; they proceeded based on the knowledge that there would be a need and opportunity for the production of their vaccines. With the arrival of COVID-19 and the Covax Initiative, there soon came the realization that for the sake of pandemic preparedness and global survival, low and middle-income countries need to be able to produce their own vaccines. These countries did not get a sufficient supply of the COVID-19 vaccine when it became available and were not able to meet the needs of their populations. The mRNA was the most versatile platform to help these countries produce their own vaccines. Prof Terblanche added that leveraging public-private partnerships is a key success factor in having an end-to-end value chain established.
