Addis Ababa, Ethiopia; Boston, MA, USA; Seattle, WA, USA — Form/fill/finish capacity is strong while end-to-end local vaccine production will require additional investment.
The Africa Centres for Disease Control and Prevention (Africa CDC), the Clinton Health Access Initiative (CHAI), and PATH have released a new briefing paper, "Current and planned vaccine manufacturing in Africa," following an assessment of vaccine manufacturing capacity in Africa.
African vaccine manufacturing is set to expand dramatically as the continent works to safeguard itself against future pandemics and disease outbreaks--and to ensure delays like the ones African nations faced in receiving COVID-19 vaccines never happen again. A clear picture of gaps and needs in the current vaccine manufacturing ecosystem is necessary to ensure all stakeholders are aligned moving forward and new projects and investments can succeed.
The assessment looked across the two critical steps needed in the vaccine manufacturing process: producing the active vaccine component, or antigen, which is the most cost-intensive and technically challenging step; and producing the final vaccine, which includes formulation, fill, and finish (form/fill/finish).
Research findings show that African vaccine manufacturing capacity is heavily concentrated on form/fill/finish, with a significant level of additional capacity still planned. If all plans are realized, capacity to form/fill/finish vaccines would more than double the projected African vaccine demand in 2030. At that level of capacity, there is a risk not every manufacturing project would be sustainable and commercially viable.
Conversely, capacity to produce antigens locally is very limited and well below the capacity that would be needed to meet regional production targets, even when capacity expansion plans are taken into consideration.
"Partnerships for African Vaccine Manufacturing (PAVM) was formed to strengthen the African vaccine manufacturing ecosystem and set Africa on the path to locally manufacture 60 percent of the continent's routine immunization needs by 2040," said Akhona Tshangela, PAVM Coordinator for the Africa CDC. "This work to map vaccine manufacturing capacity provides PAVM additional and essential clarity on how to coordinate action toward meeting that goal."
The study noted that to accelerate use of the robust capacity for form/fill/finish, Africa is reliant on technology transfers from non-African vaccine manufacturers. But there are insufficient technology transfers in place to support the majority of current and planned vaccine manufacturing capacity.
Research also concluded that some African vaccine manufacturers already have strong financial capabilities (the means to access financing for the facilities and operations needed to produce vaccines) but need to further develop their commercial capabilities (establishing a strategic business case to produce those vaccines). Recommendations on ways that African vaccine manufacturers can improve their odds of success include focusing on vaccines that have strong market potential and strengthening business planning.
"This analysis offers critical insights for understanding how to move forward while preventing under- or over-investment," said Simone Blayer, PhD, PATH's Global Head of Chemistry, Manufacturing, and Controls, and Nonclinical Toxicology. "We hope these results will help stakeholders and funders coordinate and collaborate on development efforts, interventions, and investments."
"Investor and donor support is crucial to a healthy vaccine manufacturing ecosystem, but careful consideration should be given to how that investment fits into the whole," said Frauke Uekermann, PhD, Director of Vaccines Markets at CHAI. "Ensuring stakeholders are aligned and investments strategically targeted will significantly improve manufacturers' long-term odds of commercial sustainability."
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The Africa CDC, CHAI, and PATH are now working to act on the findings of the assessment. The Africa CDC is working with African Union Member States to support the procurement of African-made vaccines and prioritize activities that will help local vaccine manufacturers meet the PAVM 2040 goal. CHAI is working with key stakeholders to develop an integrated set of high-impact market-shaping interventions and support in their execution. And PATH is working with partners to develop a supply chain simulation that could help estimate the manufacturing site conditions--including types and size of future factories, workforce numbers, and types of expertise--needed to achieve the planned capacity.
This work was made possible by the support of the American people through the United States Agency for International Development (USAID) and by funding from the Bill & Melinda Gates Foundation. The contents do not necessarily reflect the views of USAID or the United States Government, or the Bill & Melinda Gates Foundation.
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