What you need to know:
Dr Patrick Osewe, chief of the Health Sector Group, Asian Development Bank (ADB), is responsible for providing leadership on all technical and operational matters.
Before joining ADB, Dr Osewe worked as the World Bank’s global lead for healthy societies, providing technical and operational guidance to countries to address public health challenges including pandemics and combatting the emerging threat of non-communicable diseases.
Dr Osewe spoke to Senior Health and Science Reporter Angela Oketch on whether Africa as a continent is prepared to manufacture its own vaccines, what is involved in manufacturing a vaccine and whether there is a market for the final products.
What is the potential of vaccine manufacturing in Africa?
A study conducted by the Clinton Health Access Initiative (CHAI) looked at current and potential vaccine manufacturing on the African continent. In 2021, the estimated production capacity for Covid-19 vaccines was about 825 million doses. The target in 2022 and 2023 is to produce about 3.1 to 3.5 billion vaccines.
South Africa has a lot of manufacturing capacity. Aspen International, for instance, never produced a vaccine before, although it has produced many other pharmaceuticals (ARVs and other products).
With financing from the International Finance Corporation and Johnson & Johnson as a technology partner, Aspen was able to strengthen its capacity and produce the Johnson & Johnson vaccine within six to 12 months.
There are a number of companies in South Africa that are able to produce vaccines, including Afrigen Biologics and Vaccines and the Biovax institute.
Despite being small, Senegal also has good capacity. It has been producing the yellow fever vaccine for almost 30 years and Institut Pasteur has a lot of experience producing vaccines.
When the Covid-19 pandemic began and companies were looking for collaborators to produce vaccines, the natural partner was Institut Pasteur in Senegal.
Rwanda and Ghana
Beyond South Africa and Senegal, there are other companies in several other countries that are trying to produce Covid-19 vaccines through various partnerships across the continent. Rwanda and Ghana have combined forces and partnered to produce vaccines. In this partnership, manufacturing is being done in Rwanda and the regulatory components are being overseen by the Ghana regulator.
Beyond the Covid-19 vaccine, what is the market like for vaccines?
Beyond Covid-19, there are opportunities to produce other vaccines. GAVI, the Vaccine Alliance, purchases vaccines for low-income countries and many of these countries are becoming wealthier.
GAVI’s requirement is that they only supply to low-income countries and those that are just emerging from the low-income bracket. As countries become richer, the less support they receive from Gavi. By 2026, more countries will stop receiving subsidised vaccines from Gavi.
In Kenya, for example, once support from Gavi ends, the Treasury will have to allocate funds for the purchase of vaccines.
In East Africa, where several countries have a high birth rate, they require a considerable supply of paediatric vaccines. Millions of children are born annually in Ethiopia (3.6 million), DR Congo (3.2 million), Tanzania (2.2 million), Uganda (1.6 million) and Kenya (1.2 million).
As a result, there is a market for vaccine manufacturing in the region. Should the manufacturing aspect work, there is a ready market for vaccines in the region.
What is your takeaway message for African countries before they proceed to vaccine manufacturing?
Countries should conduct a great deal of analysis before they proceed with any vaccine manufacturing process. Upon reflection, at the height of the HIV pandemic, the worst crisis on the continent was in southern Africa. President Mugabe decided that Zimbabwe would produce a vaccine for the sub-region.
A local manufacturer was supported by the government to produce ARVs and Zimbabwe wanted other countries to purchase them. We (I was with the US government at the time) conducted an analysis and given the inefficiencies in the system, if Zimbabwe was to produce the ARVs, it would cost about $34 per person per month, while the ARVs that were being produced in India cost about $17 per person per month.
Assuming you were in Botswana, or any other country wanting to purchase ARVs, the cost-saving approach would be to purchase from India.
Zimbabwe sold ARVs for only two years before the initiative collapsed because no one would purchase them at a higher price.
Countries should also consider the vaccine ecosystem. This includes infrastructure as well as research and development because research capacity in Africa is still limited.
However, there is an opportunity for research companies in Africa to partner with the Global North in order to conduct clinical research on the continent.
Another consideration is animal research and testing facilities. Before phase one of clinical trials, a lot of the research is conducted on animals. Therefore, countries need the capacity to do that. The clinical trial framework is another area in countries that need biotech scientists and it takes years to train them.
Training and development are also key factors. The national immunisation technical advisory group is equally important. It should have the relevant expertise to avoid questions or concerns about vaccine safety after manufacture.
There is still a lot of vaccine hesitancy around Covid-19 vaccines because many governments on the continent did not engage and educate communities before introducing the vaccines.
Healthcare worker training is also critical in this respect because some healthcare workers themselves are fearful of the vaccine. Thus, it’s very difficult for them to convince someone else to take the vaccine.
Countries should consider not only the maturity level of their national regulatory authority but also ways in which they can cooperate with other regulators – both to improve efficiencies and to build their own capacity.
We at ADB established a Regional Vaccine Advisory Group (RVAG) at the height of the pandemic to help provide member countries with technical, scientific and regulatory advice on the quality, safety and efficacy of Covid-19 vaccines.
Countries, therefore, should look at how they can improve the regulatory environment not only domestically but also with their neighbours through work-sharing, reliance on stronger regulators’ reports or joint assessments.
This kind of cooperation across borders will serve to create an enabling environment and confidence for vaccine manufacturers and will strengthen regional health security.
Sufficient human resources and a strong lab backup are other considerations.
Understanding that vaccine manufacturing is important, in theory, is one thing. Being able to make vaccines or even having the funds/budget to purchase them is another.
One of the problems facing African countries is a lack of appreciation of the technology involved in making vaccines. Most countries do not have the ability to pay for vaccines once they are on the market. Why so?
It’s not easy to manufacture vaccines. Countries must secure the right technology partner and have the capacity to make vaccines that are suitable for people. We have many manufacturers right now and the market is becoming more complicated.
At the beginning of the pandemic, when vaccines were not readily available, countries opted for any vaccine as long as it was a Covid-19 vaccine. But now that people have more options, they are choosing vaccines according to their preferences and their underlying health issues.
With regards to the market, simply because products are available on the market does not mean countries have the ability to pay for these products. And in almost all cases where public goods have been available on the market, African countries have relied on donor partners to buy these goods and provide them to the public free of charge.
Many countries still rely on international financing, and only a few have taken over the procurement of life-saving commodities.
Countries must consider the health security of their populations and should allocate resources accordingly. For example, countries with large populations of people with HIV should not only rely on external support, because when this support dries up, those living with HIV/AIDS are also in danger.
The assumption from these countries that rely on donors is that the donors will always be there to support them to purchase these critical commodities. This is not the case. They must allocate their budget accordingly.
How can countries including Kenya and South Africa that have invested so much in animal health and vaccine facilities convert these human vaccine facilities?
Some countries that have been producing animal vaccines have now begun to produce human vaccines, and there are some similarities (e.g., the need for a regulator). Certain steps are also the same.
But countries cannot just convert facilities used for developing animal vaccines to produce human vaccines. It’s a long process. The regulations and the kind of technology partners are different. An entire process is needed to convert an animal vaccine facility to a human vaccine facility but it is not as complicated as having to start the process afresh.
Can you give a general take on the cost-benefit analysis of vaccine manufacturing by describing whether it makes sense for Africa to manufacture its own vaccines vis a vis importing them from elsewhere?
When doing a cost-benefit analysis, one has to look at the cost of production, the various inputs and their costs, the market, and other aspects like transportation and the benefit for the continent.
Africa is a huge continent with a young and growing population and therefore manufacturing is something central for the continent to achieve health security.
Manufacturing should be done in a collaborative manner; not every country can produce its own vaccine. Companies are thinking beyond Covid-19. If Covid-19 comes to an end, facilities should be able to be used to produce other vaccines (e.g., countries with a high birth rate should be able to produce more paediatric vaccines than any other kind).
Africa has a large population and of all vaccines used in the continent, only one per cent are manufactured locally. Thus, it is vital to increase the capacity to manufacture vaccines as these are public goods. However, the capacity to manufacture vaccines involves many aspects and has several levels – from clinical research to manufacturing scientists and regulation.
Countries considering manufacturing Covid-19 vaccines should recognise that each of these requires massive investments, which ultimately are good for the country.
The processes are still the same for other vaccines. But given that Covid-19 is fading away, countries should reflect on whether or not the platforms they have in place are only for the Covid-19 vaccine manufacture or can be converted to produce other vaccines as well.
They should also consider their technology partner and whether or not it has a global market for vaccines other than those for Covid-19.
Is mRNA a viable technology in vaccine production? Is it a solution to Africa`s vaccine problem?
Though mRNA technology has been commercialised for Covid-19, it has great potential in terms of emerging diseases. For example, it took 325 days to make the Covid-19 vaccine, compared to malaria, which has been with us for a long time.
Africa should invest in vaccines that are relevant to its health priorities on the continent, including HIV and even TB, choose the right technology partners, and also lead in certain areas of research.
The technology may be useful for cancer and other diseases, but it has not been approved to treat other kinds of conditions. Still, for Covid-19 it has worked well.
Countries should choose a platform that can be used beyond Covid-19 and that can treat other illnesses.
Are there any vaccine brands that are indigenous to Africa?
There are Covid-19 vaccines that are indigenous to South Africa. The yellow fever vaccine is manufactured in Senegal for the rest of the world.
What would it take for Africa to manufacture its vaccine starting from scratch, rather than depending on partnerships and high-income countries?
Africa needs to have strong research institutions which produce excellent scientists. They are there, but the problem is they don’t know each other. They need to work together and network as they do research and share expertise and knowledge.
The partnership is critical but to what extent? Countries and member states need to own the projects and make them their own by investing in vaccine manufacturing.
What do we need to know about vaccine manufacturing?
First, vaccines are given to healthy people. That is, they are different from clinical trial medications, which are given to sick people. Therefore, biosafety and biosecurity are critically important, which is why manufacturers must have a state-of-the-art manufacturing facility that adheres to internationally recognized good manufacturing practices to ensure the development of quality, safe and efficacious products.
Second, highly skilled human resources are required due to the number of steps involved in vaccine manufacturing, each with its own special skills and expertise. For example, biotech scientists are needed to produce the drug substance and many other cadres of staff are required in the process – including those specialised in clinical trials, production and distribution of vaccines.
A technology partner is also crucial. For example, Kenya, Ghana or Rwanda, and all the other countries that are trying to manufacture vaccines now, need to partner with a country that has been doing this for a long time.
Given its complexity, vaccine manufacturing is not something that a country can just decide to do. A country can’t just put up a facility and start making vaccines.
They must work closely together with a partner who can transfer the technology and provide appropriate training.
A strong national regulator is another component. Without a strong national regulator to oversee compliance with and adherence to good manufacturing practices, the vaccine quality and safety may be called into question, making it difficult to export.
What are the three phases of vaccine manufacturing?
The first phase is fill and finish. This is the relatively easy part, whereby the vaccine comes from a manufacturer like Moderna or Pfizer. The manufacturer then enters into a partnership with a country – like Kenya or Nigeria or Morocco – to quickly fill the vaccine so that it can be used in the country or exported at the sub-regional level.
Companies utilise this process to rapidly scale up manufacturing across continents and reach wider populations. This process takes about 12 to 16 months and it includes technology transfer, training, and support for the facility that is already manufacturing vaccines or medicines so that they can produce them within the stipulated time frame.
In this case, all the research and the product come from somewhere else.
The second phase is contract manufacturing. This involves using an existing facility that is already manufacturing other vaccines. For example, a company manufacturing polio vaccine now might decide to start manufacturing Covid-19 vaccines.
This involves going through the process of pre-formulation, formulation development, and stability studies to ensure that whatever vaccine is being produced at the parent company is the same vaccine at the contracted facility.
This process takes slightly longer – around three years. It creates a lot of manufacturing and human resource capacity in some countries, such as India and the People’s Republic of China. By having contract manufacturing in a country, you begin to develop the skills and expertise that are required to make vaccines from scratch (the biotech scientists, the clinical research team, etc.)
The last phase is full-scale biomanufacturing. This usually takes three or five years, but can sometimes take up to seven years.