We know from before and during the COVID-19 pandemic that Africa’s demand for vaccines exceeds its local supply: 99% of vaccines administered on the continent are imported. The pandemic highlighted an existing need, but did it also galvanise action to establish greater “local” manufacturing? A recent report by Africa CDC, the Clinton Health Access Initiative (CHAI), and PATH, examines “current and planned vaccine manufacturing in Africa”. Here we look at the findings and recommendations presented in the report.
Why does Africa need manufacturing?
Apart from the pressures placed on Africa during the COVID-19 pandemic, Chatham House suggested in 2022 that “seven of every ten vaccines” used in Africa are donated by Gavi. A year before that, WHO Africa reported on the “enormous challenges” to establishing sustainable vaccine industries. The imbalance in production contributes to “unequal access” and “enormous health disparities” suggests this latest report.
In the report, Africa CDC, CHAI, and PATH analyse the current and planned manufacturing capacity in Africa, at a time of expected growth. The hope is that the paper will offer “insights into what is needed to develop a robust and sustainable vaccine manufacturing ecosystem”.
The process behind the paper
Although Africa needs a more effective vaccine manufacturing ecosystem, current capabilities are set to “expand dramatically” because of the COVID-19 pandemic. This highlight inequities and provoked a “surge in local political support for vaccine production”. So, what does the environment currently look like, and what might it turn into in the future? To answer these questions, a collaborative team engaged vaccine manufacturers across Africa between December 2022 and March 2023 on “current and planned production capacity, technical and commercial capabilities, and supporting functions”.
19 manufacturers were engaged in total, including manufacturers with commercial scale production capacity and early-stage projects. The team also involved a “variety of originator companies” outside Africa that are interested in technology transfers. The goal of this involvement was to identify their perceived “opportunities, challenges, and considerations for collaboration”.
The “benchmark” for vaccine demand was 2030, but 2040 is also considered in line with PAVM Framework for Action, which “sets the goal of manufacturing 60% of Africa’s routine immunisation needs on the continent by 2040”. The authors note that “other aspects of the vaccine manufacturing ecosystem” such as infrastructure development and improvement, regulatory authority strengthening, and market shaping, are not covered in the paper.
Finding 1: too much form/fill/finish not enough antigen production
The first finding in the paper identifies an “excess” of form/fill/finish” in contrast with a “dearth of antigen production”. The analysis explored two critical steps in the manufacturing process:
- Drug substance production – the most cost-intensive and technically challenging step
- Drug product production – including formulation, fill, and finish (form/fill/finish)
The authors suggest that “current capacity”, including ordered capacity, to form/fill/finish vaccines with imported antigen is “around 2 billion doses”. This “far exceeds” the average annual demand of 1.3 billion doses, yet further capacity is planned to increase production by “2 billion-plus doses”.
“The scale of overcapacity means there is a risk not every manufacturing project will be sustainable.”
On the other hand, antigen production capacity is “very limited” and “well below” the capacity required for PAVM’s domestic production targets. Furthermore, a significant proportion of antigen production is now used for non-vaccine products. Unfortunately, plans to expand manufacturing are “not enough to close the gap between production and demand”.
Finding 2: limited access to technology transfer
“Africa is reliant on technology transfers…due to the complex nature of vaccine manufacturing and the urgency with which manufacturers needed to scale production on the continent.”
At present, the research team identified “limited technology transfers”, which mean that African vaccine manufacturers may only be able to produce a “fraction of what they theoretically could”. They note that “technology transfer can be an important step in developing capacity to produce antigens locally”. Furthermore, “uncertain demand commitments” from governments for African-made vaccines add a complication.
“Demand uncertainty creates a barrier for African vaccine manufacturers…even among those manufacturers that have been able to sign agreements, unclear demand is delaying implementation of those transfers.”
Finally, a “single vaccine manufacturer” drives most current technology transfers to Africa. Thus, a “significant dependence” is established, making the “ecosystem vulnerable”.
Finding 3: available capacity does not equal commercial success
Although African manufacturers have “potential”, this does not guarantee “commercial success”. For example, despite “strong financial capabilities” for many manufacturers, commercial capabilities must be developed.
“Success depends on commercial savvy, market access, and effective partnerships, among other important factors.”
However, the “biggest obstacles” to the development of sustainable vaccine manufacturing capacity are “market access and demand materialisation”. Going global is easier intended than realised, and the report recognises “challenges breaking into the regional and global markets”.
“Local government support has been a driving force behind many manufacturers’ plans, but it has also led to strategies that are aligned to local political decisions rather than global market requirements.”
Recommendations and next steps
As is often the case, the importance of “investor and donor support” is raised as “crucial to a healthy and sustainable vaccine manufacturing ecosystem”. However, “careful consideration” must be given to how each investment supports “the whole” and pandemic preparedness. Similarly, stakeholders in Africa should “focus on efforts that build the continental vaccine manufacturing ecosystem” over “efforts that only benefit a particular manufacturer or country”.
Investors and donors should…
- Reconsider investments in form/fill/finish capacity building in favour of efforts that strengthen commercial viability
- Strengthen end-to-end manufacturing capabilities with investments that build capacity to manufacture antigens locally
- Fund technical support to achieve international standards for Good Manufacturing Practice and prepare for/secure WHO prequalification
African manufacturers and governments should…
- Improve the likelihood that investments have the right effect by strengthening commercial strategies and business planning, determining a clear pathway to market access
- Diversify technology transfer partners to mitigate the risk of a market monopoly for antigen production
- Be more precise in demand commitments for African-made vaccines, to catalyse technology transfers and create a market
These steps are a “multi-year, complex undertaking” and will require collaborative efforts. Thus, each of the partners outlines specific areas of commitment.
PATH – working with partners to determine the conditions needed to achieve the planned capacity, referred to as “future state mapping”.
CHAI – working with key stakeholders to develop a set of high-impact, market-shaping interventions and support in their execution, including addressing the strategic and commercial gaps identified through the landscaping exercise.
Africa CDC – working with African Union Member States to agenda-set activities guided by the PAVM Framework for Action by developing initiatives to support the procurement of African-made vaccines.
Do you agree with the findings and recommendations set out in the report? If you are based in Africa, how realistic is this? If you are in other areas, what lessons can you learn from this perspective?
If you are interested in discussions about African manufacturing check out our interview with Professor Terblanche of Afrigen. For more on technology transfer, check out this conversation with Dr Ike James, Medicines Patent Pool.
We look forward to learning more about global manufacturing and African-made vaccines at our Congress in Barcelona next month as well as in Washington next year. Are you joining us? Don’t forget to subscribe for more like this.
