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Developing an enabling environment for sustainable vaccine manufacturing in Africa

Vaccines and conspiracy theories in Nigeria

The global drive to boost vaccination coverage has proven to be one of the most profoundly successful endeavours in global health. Yet, despite the high regional demand for vaccines worth well over US$1 billion annually, Africa’s vaccine industry is still nascent, fulfilling approximately 0.1% of global supply.

The COVID-19 pandemic highlighted new and pressing challenges to Africa’s vaccine supply resilience as a critical factor in global health security. Early delays in obtaining doses on the African continent stimulated a new resolve to address future supply security. In response, the African Union has set the ambitious goal, of developing, producing, and supplying 60% of the vaccine doses required on the continent by 2040. This goal, if achieved, will improve self-reliance and ensure a sustainable supply of vaccines, as well as increase preparedness for outbreak response.

Supporting an enabling environment for local vaccine manufacturing

In light of the African Union’s goal, the last few years have seen an increase in political commitments to steering the local vaccine manufacturing agenda, with significant efforts being made to create an enabling environment for sustainable vaccine manufacturing in Africa. The African Union’s Partnerships for African Vaccine Manufacturing (PAVM) and others have highlighted the many barriers within Africa’s vaccine ecosystem that limit sustainable vaccine production.

If the continent is to benefit from novel vaccine products, platforms, and technological processes, then an ecosystem fostering skilled human resources will be essential

These challenges span the entire vaccine value chain, from domestic vaccine investment and budgeting to skill development, technology transfer, research and development of product profiles suitable for lower-income settings, regulatory capacity, and economic considerations. While efforts are being made to address these challenges, significant work still needs to be done.

In view of this, Bloom Public Health, an indigenous public health think-tank in Africa, recommends that the following critical factors be addressed urgently to create a healthy ecosystem on the continent that can support sustainable vaccine production:

1. Skills development

Investment in human resources is a key enabler of a sustainable industry. The African continent, and particularly sub-Saharan Africa, suffers from acute skills shortages in pharmaceutical, biotechnology, and related industrial workforces. This is driven both by initial scarcity and by the brain drain of local talent, resulting in an overreliance on imported expertise.

Recent modelling has found that the importation of skilled workers is a major potential cost driver for new facilities in Africa. Modern vaccines are considerably more complex than small-molecule pharmaceuticals, requiring rare skills and highly specialised industrial processes. If the continent is to benefit from novel vaccine products, platforms, and technological processes, then an ecosystem fostering skilled human resources will be essential.

A number of initiatives are seeking to address this skill shortage. These include PAVM’s proposal to set up a series of Capability and Capacity Centres to foster partnerships between research institutions, manufacturing companies, and educational institutions.

Bloom Public Health has also partnered with Biotech Training Facility in the Netherlands, to set up the African Vaccine Academy (AVA). The AVA is an African-wide initiative that will provide training on general bio-manufacturing processes with access to self-paced eLearning interactive training materials, webinars, and virtual classrooms, as well as practical hands-on biopharmaceutical training at the Biotech Training Facility in Leiden, Netherlands.

2. Vaccine technology transfer

Human resource capacity will not be adequately built without technology transfer. The wide range of specialities required across the vaccine value chain includes a range of skills normally developed through direct exposure to drug substance development and manufacture.

To address this challenge, the World Health Organization (WHO) has established a global technology transfer hub for mRNA vaccines in South Africa, and six countries have already been identified to receive training (Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia).

The goal of this initiative is for manufacturers from LMICs to receive the training and licences to manufacture vaccines locally through technology transfer. Efforts should therefore be made by African countries to take ownership of this project and secure a pipeline of talent for vaccine manufacturing in Africa.

3. Research and Development

There is a need for African participation and ownership in vaccine development, from pre-clinical research through clinical trials, especially for diseases in Africa for which no vaccine currently exists. However, participation in the full vaccine value chain will require significant investment over time in African biotechnology facilities and research capacity. African governments should explore public-private partnerships to ensure sustainable financing for research, development, and innovation in vaccine manufacturing.

Read also: Nigeria eyes malaria vaccine consignment at WHO’s second window

4. Regulatory capacity

Expanding vaccine manufacturing capacity will necessitate the strengthening of Africa’s regulatory environment. African governments must invest in the strengthening of their MRAs to meet the WHO Global Benchmarking Tool (GBT) maturity level 3.

A feat that has been achieved by only Ghana, Tanzania, Egypt, and Nigeria. The achievement of the African Union’s goal is critically dependent on new facilities being able to export products to procurement partners like UNICEF with sufficient regulatory authorisation.

In conclusion

The journey towards achieving the African Union’s 2040 vision is an ambitious one that requires concerted effort from all stakeholders to tackle the existing challenges in Africa’s vaccine industry and create an enabling environment that sustainably supports vaccine production in Africa.