What will it take to develop a sustainable vaccine manufacturing ecosystem in Africa? – Africa CDC

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A study of current and planned vaccine manufacturing capacity in Africa offers insight into how to target investments and development efforts to promote long-term success.

Africa is largely dependent on other regions of the world for life-saving vaccines. Currently, only 1 percent of vaccines administered in Africa are produced locally; the remaining 99 percent is imported. Such an imbalance in production can contribute to unequal access to needed vaccines and huge health disparities between regions.

However, the tide is turning; Investments in vaccine manufacturing in Africa have increased in recent years, as Africa strives to protect itself against future pandemics and epidemics, and in particular to avoid the delays that African countries face in receiving vaccines against COVID-19. But with so many new projects on the horizon, disparate and uncoordinated efforts risk resulting in duplicate investments in some areas and underinvestment in others, which could undermine long-term impact .

Increasing vaccine manufacturing capacity in Africa will be a complex, multi-year undertaking that will require stakeholders from the public, private and social sectors to work together to create a strong enabling environment. Where do we start?

Together, the Africa Centers for Disease Control and Prevention (Africa CDC), the Clinton Health Access Initiative (CHAI) and PATH reviewed current and planned vaccine manufacturing capacity in Africa to generate insights into what is needed to develop a robust and sustainable vaccine manufacturing ecosystem. Details are available in a new information document and this information can help stakeholders and donors better coordinate and prioritize development efforts, interventions and investments.

Akhona Tshangela, African Vaccine Manufacturing Partnerships (PAVM) Coordinator for the Africa CDC; Frauke Uekermann, PhD, Director of Vaccine Markets at CHAI; and Simone Blayer, PhD, Global Head of Chemistry, Manufacturing, Controls and Nonclinical Toxicology at PATH, share their insights on the project and how we can help advance vaccine manufacturing in Africa.

What capacity does Africa have to manufacture vaccines locally?

Dr Blayer: Africa has more than sufficient capacity to formulate, fill and finish (form/fill/finish) vaccines. Current capacity is around 2 billion doses, almost double the average annual demand for vaccines. And greater form/fill/finish capacity is expected; If all of this comes to fruition, the capacity to form/fill/finish vaccines would more than double projected African demand for vaccines in 2030.

At the same time, the capacity to locally produce antigens, the first step in the vaccine manufacturing process, is very limited. Even when capacity expansion plans are taken into account, local antigen production will significantly lag behind the continent’s form/fill/finish capacity.

What are the main obstacles to building sustainable vaccine manufacturing capacity?

Dr Uekermann: Commercial viability is a huge challenge. The significant excess form/fill/finish capacity means that there will likely not be an available market for all manufacturing projects considered. Additionally, support from local governments has been a driving force behind many manufacturers’ projects, leading to strategies aligned with national policy decisions rather than market demands, presenting challenges for penetrating markets. regional and global needs for success.

Another barrier is limited access to technology transfer. Africa relies heavily on technology transfers with non-African vaccine manufacturers to utilize already installed production capacity. But today, technology transfers are insufficient given the uncertainty of market demand. There are also not enough technology transfer partners. Existing deals are largely with a single non-African vaccine manufacturer, potentially creating a high dependency on a single organization.

Where is Africa’s vaccine manufacturing ecosystem strong?

Ms. Tshangela: The commitment of African leaders to strengthen vaccine manufacturing capacity has accelerated the development of a road map to make Africa self-reliant. For example, in 2021, African Union Heads of State and Government formed PAVM to strengthen the continent’s vaccine manufacturing ecosystem and set a goal of locally manufacturing 60 percent of vaccination needs of Africa by 2040. Over the past two years, we have seen investments in regional manufacturing total well over $1.5 billion, underscoring the global commitment to supporting the continent’s efforts to diversify the manufacturing of health products and ensure global health security for all.

We are getting closer. During site visits for this study, we saw advanced manufacturing facilities on the continent with adequate operational capabilities. With the right resources, such as financial support, technology transfer and demand certainty, these facilities could be ready for use if the next pandemic occurs.

Where should donors and other stakeholders direct their efforts?

Ms. Tshangela: It is crucial to target investments and scale efforts strategically. Longer term, the most strategic investments are those that will focus on building local antigen manufacturing capabilities – this can help alleviate some of the reliance on technology transfer and build capacity end-to-end vaccine manufacturing. But in the short to medium term, it is also important to fund technical support activities that can help manufacturers meet international quality standards such as Good Manufacturing Practices and World Health Organization prequalification.

We encourage African vaccine manufacturers to strengthen their business planning and focus on vaccines with high commercial potential to ensure economies of scale. Working with our Member States on demand commitments for African-made vaccines is also an absolute necessity: in doing so, we can not only facilitate business planning, but also accelerate ongoing technology transfers.

What happens next?

Dr. Blayer: Examining current and planned vaccine manufacturing capacities and capabilities is only one step in the process. We also need to understand the conditions needed to achieve planned capacity (e.g., types and sizes of future factories, number of employees, and types of expertise needed). PATH is currently working with partners to define these terms, which can help manufacturers clarify their business and operational needs.

Dr Uekermann: Developing a set of high-impact interventions to shape the market and supporting their execution can help fill some of the strategic and commercial gaps, such as developing demand commitments for African-made vaccines and facilitating the development of strategic technology transfers, among others. others. CHAI and key stakeholders are currently supporting this work.

Ms. Tshangela: The Africa CDC is working with African Union Member States to support the procurement of African-made vaccines and identify and prioritize activities that will help Africa achieve its manufacturing targets. This involves working with local regulators and the manufacturing workforce to provide essential skills and knowledge. This work was made possible with the support of the American people through the United States Agency for International Development (USAID) and funding from the Bill & Melinda Gates Foundation. The content does not necessarily reflect the views of USAID, the United States Government, or the Bill & Melinda Gates Foundation.

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