Can Africa Get Close to Vaccine Independence? Here's What It Will Take.

According to the World Health Organization, only 3 percent of Covid-19 doses were delivered to Africa in 2021, home to one fifth of the global population. Africa was the worst affected by the global inequity of vaccines, as it had the lowest leverage to negotiate contracts.

African leaders pledged to ensure that this never happens again. High-income countries and philanthropic organizations promised to fund the effort to increase vaccine access. The announcements were awash with new partnerships and investment: plans to modernize existing pharmaceutical manufacturing facilities in Africa, plans to build others, plans to ship shipping containers to Europe equipped with pop-up production facilities for the new mRNA vaccinations; plans to create an incubator to distribute open-source technology across the continent.

There are signs that real progress is being made. It's become clear how large the obstacles are.

The decades-long development of a sophisticated biotechnology sector that can produce a vaccine for export or even a shot protecting against a new pathogen is not a quick process.

By 2040, the African Union wants 60 percent of the vaccines that are used in Africa to be produced by African countries. This is a huge leap from the 1 percent currently being produced.

Money is always the biggest issue. Biosecurity is a must in the many-steps process of producing vaccines. Due to the cost of setting up all of this, vaccines produced in Africa will be significantly more expensive than those made by the Indian pharmaceutical industry. India is the main supplier of vaccines for routine use in Africa.

The Serum Institute of Indian, the largest vaccine manufacturer in the world, has achieved massive economies of scale, and taken over a large portion of the market that was previously held by European producers. The Covid rollout showed that African leaders can't rely on Indian-made products, despite their low cost. The Indian government banned the export of millions of Serum doses of AstraZeneca's vaccines bound for Africa in March 2021. These vaccines were then redirected to the Indian population.

According to the Africa Centers for Disease Control and Prevention, the continent's current vaccine market is estimated to be worth $1.3 billion and will grow to $2.4 billion in 2030. Many in the global health sector believe that buyers will be required to pay an'resilience fee' -- a premium for African-made products, whose production helps build the African industry. It is less clear who will be willing to pay the higher price.

Gavi is the obvious choice. This organization uses funds donated from high-income nations and major philanthropies in order to purchase vaccines and other supplies for low- and medium-income countries. Gavi purchases half of the vaccines that are used in Africa.

Aurelia Nguyen is Gavi's Chief Program Strategy Officer. She says that the organization will sign contracts for advance purchases with vaccine manufacturers in developing countries to ensure business owners an income stream to defray expansion investments.

She said: 'The traditional economics of the market that brought us to where we are today, with strong manufacturers from developing countries in Asia and Latin America, will not get us where we need to be to have regional players on the African continent.' Gavi is in a good position to solve the market failure.

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Experts say that if Gavi can provide this cushion, then these projects are likely to be the most effective in helping the continent achieve its goal of producing the majority of vaccines needed for Africans on the continent. Most will need at least three years before they have even a bottling-and-packaging line running.

In Senegal

Before Covid, the Pasteur Institute of Dakar produced a million doses of yellow fever vaccination a year and was experiencing a decline in business. It has been the target of major new investments and is close to completing a large expansion at its existing production facility. The company aims to produce 50 million doses of yellow fever vaccination per year. The second site is aiming to produce 300 million doses of a low-cost measles and rubella vaccine for the African Market.

The company will be using a new platform for bio-manufacturing from Univercells. This Belgian start-up aims to produce vaccine ingredients faster and with less space.

Prashant Yadav is a medical supply-chain expert with the Center for Global Development. He has visited the Institute several times in the last year.

South Africa

Aspen Pharmacare received $30 million from philanthropic sources to develop a production system for four main childhood vaccines including the shots against pneumonia and rotavirus.

The World Health Organization will establish an mRNA hub in 2021 at a biotechnology company called Afrigen Biologics and Vaccines located in Cape Town. This is to reverse-engineer the Moderna Covid vaccination and share mRNA knowledge with countries of the South. Afrigen plans to put its Covid vaccine into clinical trials by early 2024. Afrigen hopes that by designing, testing, and producing Covid, it will gain the technological know-how necessary to develop other products, including an mRNA vaccine for tuberculosis.

Afrigen has partnered with the BioVac Institute in South Africa, which produces childhood vaccines. BioVac has signed a contract to bottle Pfizer’s Covid vaccine, a process known as fill-finish. It also has a licensing and technology transfer agreement with International Vaccine Institute (a South Korean non-profit) to produce an orally administered cholera vaccination.

In Rwanda

Six shipping containers were delivered to the country by BioNTech in mid-March. The containers are a pop-up manufacturing line for mRNA vaccines. The modular site will form the core for a new manufacturing center. According to BioNTech, the site will be staffed with Europeans for its first five years.

Dr. Yadav pointed out that one of the biggest challenges is the fact that there is no vaccine available at the site. There is currently no demand for Covid, and BioNTech makes no other products. Most likely, a malaria or tuberculosis vaccine useful to Rwanda and the surrounding region will be available in ten years. In Rwanda, the new capacity is for production only. As in many other African countries there is no biotech sector capable of doing the research and development necessary to respond to a new disease, according Alain Alsalhani.

Beyond

Two other companies, Biogeneric Pharma, in Egypt, will receive a mRNA-technology transfer from Afrigen and SENSYO Pharmatech, in Morocco, have received significant investments to expand their production. In Kenya, the Kenya BioVax Institute is being forced to switch from making animal vaccines into human ones by the Kenyan government. It has asked Dr. Michael Lusiola to run the institute. He was an AstraZeneca executive in the United Kingdom.

Ms. Nguyen stated that the continent's ability to produce large quantities of vaccines will help it to be secure in the event of a pandemic. She said that the continent could develop this capacity by producing routine vaccines for African markets.

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Most often, this will involve fill-finish contracts for existing vaccines – putting a vaccine in bulk made elsewhere into vials. Then, companies can start manufacturing the drug substance, and eventually conduct research and develop vaccines for either known pathogens or new ones.

To export vaccines quickly, countries will need to have stronger regulatory agencies. The supply chain of vaccines will need to be improved. The Africa C.D.C. The Africa C.D.C.

Ms. Nguyen expressed her encouragement at the number of African initiatives that embrace new technologies, which will allow them to "leapfrog." In the past, producing vaccines was expensive and required a large physical footprint.

She said, 'Having a unit that is small enough to get up and run and can do five or ten million doses before switching over to another product -- I think this really changes the existing marketplace.'

The funding for many of these new initiatives is heavily dependent on philanthropic funding. This includes a large amount of money from the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations and low-cost bilateral loan. It is not known how long this enthusiasm will last. Martin Friede, the head of the vaccine research unit for the W.H.O. predicted that 'the Covid guilty will be gone by this afternoon. He said, "I don't think South Africa will agree to buy vaccines at a price higher than those from India or Europe. That's a difficult ask."

Patrick Tippoo is the chief scientist at Biovac, a major player in the African manufacturer network, and said this was what he heard in meetings. He said that there was a lot goodwill from the development financing institutions but concerns about how manufacturers could repay loans. He continued, 'That depends on product volume and access to the market.' We go in circles.

BioVac's cholera vaccine, a new product that is being manufactured in a new facility, shows both the potential and the challenges of this manufacturing capability. The global shortage is critical, and there are outbreaks in many sub-Saharan nations. It will be the very first time since decades that a drugmaker in Africa will develop a strategic vaccination, and will take it all the way through clinical development, manufacturing, regulatory approval, and BioVac hopes prequalification from the W.H.O. For global use. It will take many years and require the construction of expensive new facilities.

Tippoo stated that a number of things had advanced and if we could achieve half of these, then we would be in good shape. It will bring us closer, but the question is: Will it be close enough?