Opinion: 3 key interventions for growth in African vaccine manufacturing

Africa has had a nascent vaccine manufacturing sector for the past few decades, but events over the last four years have contributed to significant momentum in efforts to expand production capacity in Africa. Following COVID-19, the need for local manufacturing capacity at scale to ensure equitable health outcomes is clear and well accepted, continentally and more broadly, with 2024 presenting a pivotal opportunity to continue this positive growth trajectory. As we stand on the cusp of 2024, the spotlight on African vaccine manufacturing has never been more intense. Much of the momentum gained during this period was made possible by the foundation laid in earlier years by Biovac, Institut Pasteur Dakar, Institut Pasteur Tunis, and Vacsera in South Africa, Senegal, Tunisia, and Egypt, respectively. The African Vaccine Manufacturing Initiative, or AVMI, was also founded as an advocacy and networking body for the industry and the pandemic has seen AVMI’s role growing considerably. In 2019, AVMI worked with a handful of African vaccine manufacturers. The continent has now more than 25 manufacturing initiatives at varied levels of maturity, with AVMI having increasingly taken on the role of industry voice, advocate, and partner in multilateral and other stakeholder engagements on behalf of the continental industry players. Importantly, the need for a sustainable, robust, and geographically diverse set of producers on the continent was also recognized. The Africa Centres for Disease Control and Prevention, or Africa CDC, led the charge through the creation of the Partnership for African Vaccine Manufacturing, or PAVM, in 2021, which became an important coordinating platform for the establishment of local production capacity. PAVM set an ambitious target of achieving 60% continental production of the vaccines used in Africa by 2040. The PAVM Framework for Action set out a clear path on how to unlock Africa’s potential to grow vaccine development and manufacturing over the next two decades. Gavi, the Vaccine Alliance, is also developing a new financial instrument — the African Vaccine Manufacturing Accelerator, or AVMA, with approximately $1 billion of financing. AVMA seeks to provide support for sustainable long-term vaccine manufacturing on the continent, by offsetting initial costs and enabling competitive entry into the market and will be considered for approval by the Gavi Board in December 2023. The past four years have also seen an increase in African vaccine manufacturers attracting technology transfers from the international sector accompanied by investments in infrastructure expansion. Multiple technology transfer deals were struck and rolled out by African companies including Biovac, Institut Pasteur de Dakar, Aspen, Vacsera, and Sothema covering a range of vaccines such as meningococcal, COVID-19, measles/rubella, hexavalent, pneumococcal, rotavirus, and oral cholera vaccines. This positive momentum is well positioned to grow even further into 2024. However, the pace of next year’s progress will hinge on three vital interventions and commitments for unlocking the sector’s growth potential. Demand predictability Manufacturers need a multiyear revenue horizon to build economies of scale. Guaranteed offtake agreements from African governments and regional bodies as well as global vaccine purchasers that secure predictability of demand for as many vaccines as possible, for both routine and outbreak immunization programs in Africa, are essential. Governments on the continent need to commit to developing policies for preferential procurement from continental suppliers. It is therefore reassuring that a framework agreement is being developed by the Africa CDC for a pooled procurement mechanism, or PPM, of vaccines. A draft legal instrument is expected to be tabled for approval at the AU Summit in February 2024. Financial mobilization To ensure that the current momentum is sustained, there is a pressing need for increased financial commitment. If approved, the Gavi AVMA and AU PPM will be important catalytic mechanisms with significant potential to unlock sources of funding from African governments, international donors, development finance institutions, and private investors. Also, further technology transfers would be incentivized. Regulatory strengthening and efficiency A harmonized and efficient regulatory framework at national, regional, continental, and World Health Organization levels is essential. The foundation of this would depend on an increase in the number of WHO Maturity Level 3 national regulatory authorities in 2024 and beyond. The expedited operationalization of the African Medicines Agency is crucial, working together with the African Medicines Regulatory Harmonisation Program, to strengthen the regulatory system for vaccines and develop a harmonized African regulatory ecosystem. The pre-qualification of medicines by WHO, known as WHO PQ, will continue to be an important standard to access Gavi/UNICEF markets in Africa and elsewhere. It is equally important therefore that efforts are advanced to enhance the WHO PQ procedure to accelerate the inclusion of quality products available from African suppliers. 2024 will be a time for implementation It is clear that vaccine manufacturing firms together with AU partner bodies, African governments, and other stakeholders, have already established a growing movement toward building sound and viable vaccine manufacturing capabilities in Africa. 2024 represents an exciting window of opportunity to accelerate this progress by implementing key initiatives, policy and regulatory reform, as well as making enabling commitments. The promise of transformative growth beckons, contingent on key stakeholders committing to leveraging opportunities timeously. Now is the moment to push forward! Editor’s note: The views expressed are the author’s personal views and do not necessarily reflect those of Biovac or AVMI.