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EF: How has Afrigen evolved since we met last year, and what are the current priorities on your agenda?
PT: Let me begin by discussing our resources and team growth. Currently, our team consists of nearly 150 people, a significant milestone for us. What is remarkable about our team is their high level of skill and expertise. A recent analysis revealed that 78% of our staff hold bachelor's degrees or diplomas, while 47% possess honors, master's or doctoral degrees. This demonstrates the depth of knowledge within our organization. Over the past year, we have focused on enhancing skills in mRNA innovation, covering everything from vaccine design to final drug product formulation. Additionally, we have successfully scaled up our lab-scale production to a commercially viable level.
To further enhance our capabilities, we have provided extensive training to our team members, including GMP, bioprocessing, and mRNA science. This investment in our people has resulted in a highly skilled and specialized workforce in advanced biotechnology. Moreover, our team is predominantly female, with women comprising 67% of our workforce, and we pride ourselves on our diverse racial composition. In terms of infrastructure, we have completed our facilities and installed equipment for fill finish and labeling, including aseptic equipment and visual inspection capabilities.
We are in the process of obtaining qualifications and validations to secure a GMP license from SAHPRA, our national regulator. It is a key priority for us to be recognized by a stringent regulatory authority for end-to-end (drug substance and drug product) GMP manufacturing. This allows us to produce vaccines from the plasma DNA to the final product release under GMP conditions for mRNA, a capability that is unique on the continent. Our R&D capabilities span the entire spectrum, including vaccine product design and process development. It has been a productive year for us, and we are committed to sharing our knowledge and training with our partners. To date, 14 out of 15 partners have received initial training and technology transfer packages. Our overarching goal is to make mRNA accessible to low- and middle-income countries, contributing to pandemic preparedness and inter-pandemic sustainability.
EF: Regarding vaccines, what needs to happen between now and a point where Africa is self-sufficient enough to achieve sustainability on the continent?
PT: There are numerous essential steps that must be taken. Firstly, we need to ensure a comprehensive approach that connects all the necessary elements. We cannot build an entire industry solely reliant on the vaccine sector. It will not guarantee sustainability or capture the financial value we need across the continent. Therefore, it’s crucial to diversify and incorporate other platforms. We need more companies like Aspen, Biovac, and Afrigen on the continent. We need to embed and build other platforms. While mRNA shows promise and our core in Cape Town is robust, we must expand our capabilities to include other platforms like viral vectors and attenuated vaccines.
This diversity will enable us to develop a comprehensive portfolio of vaccines to meet the targets for 2040 and address the 22 neglected diseases requiring vaccines. Additionally, we need to strengthen our regulatory authorities (NRAs). Currently, we only have two on the continent, Egypt and South Africa, that are at maturity level 3 required to license vaccine facilities and products. This is insufficient. We should aim to establish at least six or seven more NRAs at ML 3 or 4 levels to ensure effective regulation and oversight. Taking a regional-continental approach is more suitable rather than attempting to establish 54 separate companies producing vaccines on the continent. We should focus on collaboration and coordination across regions to maximize resources and efficiency. This approach will enable us to pool expertise and resources, ultimately leading to greater success in vaccine production and distribution on the continent.
The current ongoing efforts to reshape the markets and enable sustainability are as important as strengthening the regulatory systems on the continent. We must push for pooled procurement models to enhance efficiency and accessibility. Moreover, we need a supportive policy environment that prioritizes local procurement, recognizing that this is not just about health security but also socioeconomic development. This environment should facilitate end-to-end processes, ensuring that we can fully capitalize on the continent's potential and meet public health needs.
Addressing the skill shortage is also paramount. Over the past two years, we have intensified our efforts, hiring professionals and providing rigorous training to operate in GMP facilities, emphasizing quality assurance and regulatory compliance. This transition requires time and investment in on-site, practical training and forging partnerships between academia and the private sector to develop a skilled workforce for the continent.
Investing in the healthcare system at the grassroots level is also essential. We need to ensure that healthcare facilities are equipped to effectively utilize the products manufactured. This involves reallocating and prioritizing healthcare budgets to create robust markets for these products. A multifaceted approach is necessary to build a sustainable vaccine industry in Africa.
One of the significant strides in progress toward enabling local manufacturing is the Gavi Vaccine Manufacturer Accelerator (AVMA), signaling GAVI's commitment to local procurement without compromising quality. Manufacturers must meet stringent quality standards to ensure that products meet international standards, a critical requirement for the continent. Gavi has allocated >$1 billion over the next decade to incentivize and support local manufacturers which has WHO Prequalification (PQ) status demonstrating the capabilities and quality standards to produce around 10 priority vaccines, primarily pediatric ones.
This initiative not only aims to address routine vaccines but also paves the way for innovation in higher-value vaccines, extending beyond pediatrics to the adolescent demographic. The collaboration between GAVI and UNICEF, alongside other global partners like the Global Fund, offers financial support and incentives to vaccine manufacturers, facilitating their journey towards sustainability. Recent discussions among Development Finance Institutions (DFIs) in Washington highlight a collective commitment to support continental manufacturers financially and achieve the goal of producing 60% of vaccines within Africa. There is also a growing acknowledgement by the DFIs of the importance of research and development (R&D) in driving progress.
Supporting R&D is crucial for advancing new product development, addressing neglected diseases, and overcoming shortages of biosimilars and biologics on the continent. There are about 5 Biotech startups in the biologics/vaccine space on the continent. They are currently facing challenges in accessing venture capital (VC) funding due to limited investment opportunities. Biotech cannot borrow money because they are pre-revenue earning. They need equity and VC investment. Fostering a robust biotech industry requires not only backing established manufacturers but also nurturing startups through partnerships and supportive instruments.
The sentiment is optimistic, recognizing that building a thriving vaccine industry in Africa requires collective effort akin to a village working together. Despite challenges, the continent is on a promising trajectory toward growth and empowerment in this critical sector.
EF: Could you elaborate on the role of your mRNA hub, and how are you collaborating with different stakeholders to make this happen?
PT: On a global level, the ongoing negotiations for the Pandemic Agreement, involving 194 states, underscore the critical need for equity and access in global health crises. The international health regulations are also being discussed. The pandemic exposed significant challenges related to vaccine hoarding, supply chain disruptions, and economic repercussions worldwide. The Agreement aims to establish a roadmap focused on equity and access at its core, emphasizing early warning systems for potential pathogens and variants, particularly those transmitted from animals to humans.
Key components of the Agreement include incentivizing governments and scientists to promptly share information on emerging threats, such as the rapid identification of the Omicron variant by South African scientists in 2022. However, concerns persist regarding access to intellectual property (IP), know-how, and knowledge, with pharmaceutical societies cautious due to the potential loss of control over proprietary information. Negotiations must navigate these complexities to find common ground among stakeholders, ensuring equitable measures, financial support, and criteria for effective pandemic prevention strategies. This involves clarifying the roles and responsibilities of international organizations, governments, and other stakeholders to enable swift and coordinated responses to future health crises.
There is a growing focus on research and development efforts, including the development of pandemic vaccines, while balancing the need for access transparency and collaboration without compromising proprietary interests – a fine balance. These discussions are vital for establishing a comprehensive framework that enhances global preparedness and response capabilities, ultimately safeguarding public health on a global scale.
We are currently working towards a project that involves developing the entire process for a pandemic vaccine but with a unique approach. Instead of progressing to phase three and registering it as a product, we are stopping at phase two. However, we are ensuring that all standard operating procedures and processes are fully prepared and operational and ready to be resumed if needed in the future.
One important aspect of the Pandemic Agreement is that it must be implemented in conjunction with other measures, such as TRIPS flexibilities addressing intellectual property issues. Relying solely on the Pandemic Agreement in isolation to resolve all global IP and access challenges is unrealistic. However, when combined with mechanisms like waivers and TRIPS flexibilities, it can contribute to creating a more effective system that ensures access and equity.
If you look at the International Aviation Regulations agreed upon by 194 states, they are strictly enforced with no tolerance for unsafe conditions. Similarly, health regulations should hold countries, communities, and regions accountable for their health commitments without compromise. It is concerning that health treaties seem to be weakened compared to other global regulations, and this disparity requires serious reflection and corrective action. We should draw lessons not only from scientific perspectives but also from our approach to addressing global health challenges.
EF: How do you instill the vision and passion of a disruptive culture in the rest of the company?
PT: I believe the key word here is "engagement." We prioritize engagement with our entire A-team (Afrigen team). I make it a point to connect with each staff member on a one-on-one basis at least once a year, getting to know them on a deeper level. Leadership is about people. However, I have noticed that as we expand rapidly, it becomes challenging to know each team member and what motivates and demotivates them, which is something I am actively working on retaining. We do ensure regular engagement through monthly staff meetings, building a common goal and vision.
Our organizational structure is very flat, and you might even find me pitching in with tasks like washing dishes in the kitchen when needed. We have an open-door policy, fostering an environment where everyone feels valued. While I wish we could compensate our employees more generously, we focus on providing them with opportunities for growth and development. We aim to keep the vision alive by fostering connectivity and engagement among the team.
Despite encountering challenges and making mistakes along the way, we adopt a non-punitive approach. When faced with significant issues, we prioritize problem-solving over assigning blame, emphasizing a culture of continuous improvement and positive energy within the organization.
EF: When you reflect on the past four years, what achievements or milestones are you most proud of, and how do you look forward to the next four years?
PT: The journey we have embarked on in collaboration with the WHO, MPP, South African Medical Council and local universities has been marked by significant milestones. The first milestone was when an international panel reviewed our proposal and selected us among other contenders, despite our small team of only 12 people at the time. While we lacked size, we possessed strong skills and valuable partnerships.
The second milestone came in November 2021 when we were told that there would be no tech transfer or funding for us. At that point, none of our 150 team members had ever worked with mRNA directly in a laboratory setting or in a crisis. We only had a basic knowledge of the subject. However, just two years later, in December 2023, we had transformed a clean room with empty panels into a fully equipped facility capable of manufacturing mRNA vaccines comparable to registered products. This rapid progress, achieved within just two years, is a testament to the dedication and expertise of our team and the strong science basis in South Africa.
We have moved swiftly to establish an end-to-end facility heading for a GMP license, a feat that even larger companies with more resources have taken longer to accomplish. Despite the challenges, we have been able to build 18 strong international partnerships and collaborations, driving innovation, advancing mRNA technology, and improving thermostability and affordability to shorten the response time during a pandemic.
We have five vaccine candidates in development, and we are building a pipeline while we are innovating and changing the science of mRNA. We and our partners are making strides that benefit not only South Africa but also the broader African continent. What is truly remarkable is that all of this progress has been achieved with relatively limited resources, demonstrating our team's resourcefulness and commitment to making a difference. While the journey has been challenging, it has also been incredibly rewarding, showcasing what can be achieved with dedication and proper support.
