Vaccine manufacturing in Africa: An urgent need for self-reliance

Although Africa is home to 17% of the world’s population, its lack of vaccine manufacturing capacity means that it can currently produce only 1% of its vaccine needs, the remaining 99% are imported. Africa’s vaccine capacity has depended almost entirely on international donors; Gavi, a global health partnership representing international donors, buys vaccines at low prices from pharmaceutical companies. UNICEF has a vast network to distribute these vaccines across low- and middle-income countries.

African companies currently operating across the vaccine manufacturing supply chain are mostly engaged in packaging and labelling, and occasionally fill and finish steps. There is very limited upstream production. In partnership with international financiers, Senegal hopes to build a vaccine manufacturing facility with the Fondation Institut Pasteur de Dakar. This would be the first in Africa to actually manufacture the substance of vaccines in parallel with fill-and-finish.

In Nigeria, Biovaccine Nigeria Ltd, a joint venture between Nigerian government and a local pharmaceutical company (May and Baker PLC), hopes to start a local vaccine manufacturing facility in the next few years, but will be engaging in fill and finish in the short term.

A few other countries like Ghana, Ethiopia and Rwanda are also looking at local vaccine manufacturing. Vaccine manufacturers in Africa are faced with a high cost of production and challenges involving poor regulation and quality assurance.

Africa’s dependency on external vaccine supply creates a serious challenge for its health resilience. The population of Africa is projected to reach nearly 2.5 billion by 2050. Therefore, the situation could be even more critical in the future if significant actions towards self-reliance are not aggressively implemented.

COVID-19 preparedness and health implications

The Covid-19 pandemic has brought Africa’s poor vaccine manufacturing capacity to full light. With no capacity to manufacture vaccines for over 1 billion people, the continent has to depend on external suppliers for Covid-19 vaccines. Due to the shock in the system and the need for vaccine security, most countries have focused on their own needs and continue to stockpile vaccines while Africa is left out. These challenges make it difficult for African governments to implement their rollouts, leaving the vast population unprotected.

As at December 27th, 2021, over one year into the pandemic, only 8.9% of the African population has been fully vaccinated. Africa lags behind significantly when compared to other continents like Asia (55.4%), Europe (60.7%), South America (63.3%) and North America (57.8%). Going by the current rate of vaccination in Africa, the African Union’s goal of 60% vaccination by 2023 and the global vaccine distribution mechanism COVAX’s goal of 20% by 2022 seem unachievable unless there is a radical intervention to change the current trend.

The vaccine shortage and setbacks in Africa hold dire consequences for the health of its people. In most countries, populations at highest risk, particularly frontline health workers, are given priority and vaccinated first before other less vulnerable populations. The longer it takes for the highest risk populations to be vaccinated, the more susceptible they’re to contracting the virus. Africa already has one of the lowest health workers to population ratio. Some reports put it at 1.3 workers to 1,000 people. There is a significant risk of further reduction due to fatalities from the pandemic, which must be avoided.

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The delays in vaccination will result in a greater spread of the COVID-19 virus, unnecessary morbidity and mortality. These results will not only be from the direct effect of the pandemic but also from its indirect effects on essential health services. In a survey carried out in November 2020 among 18 AU member states, 22% of respondents indicated that they or a family member had skipped or delayed health services since the pandemic began. The lack of vaccine manufacturing capacity in Africa therefore shows a severe lack of resilience which must be immediately addressed to prevent a repeat in possible future pandemics. Health systems in most African countries are already inadequate and over stressed. The pressure from the pandemic will further stress the system and possibly weaken them even more.

Increasing vaccine manufacturing capacity in Africa: What it takes

It is evident that an increase in the continent’s capacity for manufacturing and distribution, with the goal of becoming vaccine self-reliant, is the only remedy to the imbalance in the vaccine demand and supply. For vaccine manufacturing to thrive in Africa, there is a need for cooperation among governments, the private sector, and other stakeholders across national, regional, and continental levels. Harmonisation on issues like financing, R&D, regulation, and technology transfer is crucial.

There is an urgent need for the establishment of an apex body that will determine the goal and areas of focus for a continental vaccine manufacturing industrial strategy. Top policymakers need to come together to channel their expertise and experience towards developing a plan to address this. Many of these stakeholders have been playing significantly in this space. These include AfDB, Afreximbank, Africa CDC, etc. With a combined technical input from these organisations, a strategic plan can be created which will specify the roles and responsibilities of each stakeholder.

Key issues that must be addressed to increase vaccine manufacturing capacity in Africa and achieve self-reliance include:

1. Exploring financing options through investment consolidation: A study in 2015 by WHO and UNIDO stated that it will cost between $60 million and $130 million to build a vaccine manufacturing plant. Recently, the CEO of Biovac, Morena Makhoana, pointed out that building a vaccine manufacturing plant capable of producing 1 billion doses could cost up to $336 million. Investment consolidations for the manufacturing of Covid-19 vaccines are already being made on the continent. For example, in South Africa, Aspen Pharmacare is expected to produce 220 million vaccine doses through the partnership between the African Vaccine Acquisition Task Team (AVATT) and Johnson & Johnson (J&J).

However, a lot more investment is required. The continent can explore investment consolidation through a centralised investment fund. Once this is seen as a strategic health security decision, both the Governments and the private sector can mobilize funding towards achieving this. A good example is what has happened in Nigeria with the formation of Biovaccine Nigeria Ltd between the government and the private sector. This was a result of the strategic need to have vaccine manufacturing in Nigeria. It may be too early to assess, but if successful, it could be a model that can be scaled across the continent.

COVAX, the AU, Afreximbank, and other organisations on the continent can be major catalysts for resource mobilisation for vaccine production in Africa. This will create a uniform strategy across Africa, allowing each country to focus on its own advantages.

2. Strengthening research and development capacity: Research is essential to increasing Africa’s vaccine manufacturing capacity. Although Africa has a good capacity for molecular epidemiology, genomic, and human clinical trials, it lacks preclinical testing capacity for human drugs and vaccines. There is a need to boost R&D in this sector with significant funding. In a stakeholder conference held in December 2021, the Partnership for African Vaccine Manufacturing (PAVM), has unveiled a 20-year blueprint to increase Africa’s vaccine manufacturing capacity, which puts the spotlight on R&D.

Of the $30bn to be spent on implementing the blueprint, $20bn is expected to go into R&D. The research will centre on major threats like Covid-19, malaria and HIV, and priority diseases like diphtheria and meningococcal.

3. Strengthening quality assurance and regulation: In every country, there are national regulatory authorities (NRAs). These are regulatory bodies that ensure the safe and effective use of vaccines within the country. However, the lack of functional NRAs has made several Africa regulators incapable of optimal regulation of local vaccine manufacturing. It is therefore critical for African countries to upgrade and strengthen their NRAs. For a country to have vaccine manufacturing, its NRA must meet a minimum of level three of the WHO Global Benchmarking Tool. Currently, only very few NRAs in Africa have attained this.

Also, a partnership between the Africa Medicines Agency (AMA) and the African Vaccine Regulatory Forum (AVAREF) on a continental or regional level will be highly beneficial for local vaccine manufacturers. It will help to simplify the specialised activities required for vaccine-pre-market approval, and improve medicine agencies across the continent, boosting market potential.

4. Technology transfer and skills development: For Africa to start local vaccine manufacturing and achieve self-reliance, there is an urgent need for skills development, tech transfer and rotation of trained workers. Vaccine manufacturing requires an extensive skill set, particularly in areas of biopharma, quality assurance, regulatory competence, etc. The current vaccine knowledge in Africa is low. There are only 10 currently active local vaccine value chain players. 40% work entirely on packaging and labelling, and another 40% work entirely on infill and finish.

The low vaccine manufacturing knowledge is partly because of the ‘brain drain’ in Africa. Newly upskilled workers migrate to work abroad because of poor working conditions. This has made the continent dependent on the expertise of global manufacturers. To address these challenges, African Governments and vaccine manufacturers should collaborate with universities and other graduate institutions to develop degree programmes and courses that will prepare students to take on vaccine manufacturing roles, create projects with favourable working conditions that will attract talent from the Diaspora, and frequently train employees to achieve their continuous reskilling and upskilling.

The low vaccination capacity of Africa during the COVID-19 pandemic is a reminder of our need for self-reliance. Because vaccine scarcity on the continent holds dire consequences both during the pandemic and thereafter, African Governments need to urgently consider the above points to achieve self-reliance in vaccine manufacturing. This is crucial to responding to the current and possible future pandemics. As stated by the president of Rwanda, Paul Kagame, although the pandemic has been a terrible experience globally, in Africa, it should be seen as a golden opportunity to “fundamentally change the pharmaceutical manufacturing landscape on our continent.”