Can Africa get close to vaccine independence? Here is what it will take

A vial of Johnson & Johnson’s COVID-19 vaccine in Juba, South Sudan. (File photo: NYTimes)
Just 3 percent of all COVID-19 vaccine doses delivered in 2021 went to Africa, home to one-fifth of the world’s population, according to the World Health Organization. In the vast debacle of global vaccine inequity, it was Africa that was left furthest behind as the pandemic raged, and that had the least leverage to negotiate contracts.اضافة اعلان

African leaders vowed to make sure that never happened again. High-income nations and philanthropic groups promised to help fund the effort to make vaccine access more equitable. There was a flurry of announcements of new partnerships and investments: plans to modernize the handful of existing pharmaceutical manufacturing operations in Africa; plans to build new ones; plans to send shipping containers from Europe with pop-up facilities to produce the new mRNA vaccines; plans for an mRNA production incubator that would dispense open-source technology around the continent.

Now some of the hype has subsided, but there are signs of progress. Still it has also become evident just how big the hurdles are.

There are not many shortcuts in the decades-long process of developing a sophisticated biotechnology industry that can make a routine vaccine for export, let alone develop a shot to protect against a new pathogen.

The African Union has set a goal of having 60 percent of all vaccines used on the continent produced in African nations by 2040 — up from 1 percent now — a plan that’s wildly ambitious given the current production landscape.

The big issue, as always, is money. The many-step process of making vaccines needs high biosecurity and intense quality control. The expense of putting it all in place means that vaccines made in Africa are going to cost significantly more than those from the Indian pharmaceutical industry, which is the major supplier of routine vaccines used in Africa.

Manufacturers like the Serum Institute of India, the world’s largest vaccine maker, have achieved huge economies of scale and have taken over much of the market share that was held by European producers. But the COVID vaccine rollout made clear that despite the low price of Indian-made vaccines, African leaders cannot afford to rely on them. In March 2021, when millions of Serum-made doses of the AstraZeneca vaccine were bound for Africa, the Indian government imposed an export ban and rerouted those vaccines to its own population.
The big issue, as always, is money. The many-step process of making vaccines needs high biosecurity and intense quality control. The expense of putting it all in place means that vaccines made in Africa are going to cost significantly more than those from the Indian pharmaceutical industry.
The Africa Centers for Disease Control and Prevention says the continent’s existing vaccine market is worth an estimated $1.3 billion and is expected to grow to about $2.4 billion by 2030. But many who work in global health say buyers will have to pay a “resilience premium” — a higher price for African-made vaccines, the production of which helps build up the African industry. There is a lot less clarity about who is going to be willing to pay that higher price.

The obvious candidate is Gavi, the organization that uses funds donated by high-income countries and major philanthropies to purchase routine and emergency vaccines for low- and middle-income countries. Gavi buys half the vaccines used in Africa today.

Aurélia Nguyen, Gavi’s chief program strategy officer, says the organization is ready to sign advance purchase contracts with new vaccine makers in developing countries to assure business owners of an income stream that will defray investments in expansion.

“The traditional market economics that got us to a place where we have strong developing-country manufacturers in Asia and Latin America are not going to get us to a place where we’re going to have regional players in the African continent,” she said. “Gavi is in a position to bridge the market failure.”

If Gavi is able to provide that cushion, these are the projects that experts say are most likely to help the continent reach the goal of producing a majority of vaccines for Africans in Africa. Most will need at least three years before they have even a bottling-and-packaging line running.

In Senegal
The Pasteur Institute of Dakar was making 1 million doses a year of yellow fever vaccine before COVID, and its business was flagging. But it has recently been a major beneficiary of new investment and has nearly completed a large expansion of its production plant. It is aiming to increase its production of yellow fever vaccine to 50 million doses a year. A second site will produce a low-cost rubella and measles vaccine for the African market, with a production target of 300 million doses.

The institute will use a new bio-manufacturing production platform from Univercells, a Belgian startup that aims to make vaccine ingredients more quickly and in a smaller space.

“The progress in Dakar is the fastest I’ve seen anywhere in the world,” said Prashant Yadav, a medical supply chain expert at the Center for Global Development who visited the institute several times over the past year.

In South Africa
Aspen Pharmacare, one of the few serious pharmaceutical players in Africa before COVID, received an infusion of $30 million in philanthropic funds to build up a production process for four of the main childhood vaccines, including shots for pneumonia and rotavirus.

In 2021, the World Health Organization set up an “mRNA production hub” at a small biotechnology company in Cape Town called Afrigen Biologics and Vaccines, with the goal of reverse-engineering the Moderna COVID vaccine and then sharing mRNA production knowledge across the global south. Afrigen will put its COVID shot into clinical trials in early 2024. There is no longer a market for COVID vaccines, but the hope is that the process of designing, testing and producing this product will build up technological know-how to make others including an mRNA shot for tuberculosis, an Afrigen priority.

Afrigen’s production partner is the nearby BioVac Institute, which makes childhood vaccines for South Africa. BioVac signed a deal to bottle Pfizer’s COVID vaccine (a process called fill-finish), and has a new licensing and technology transfer deal to produce an oral cholera vaccine with the International Vaccine Institute, a South Korean nonprofit.

In Rwanda
Six shipping containers arrived in the country in mid-March to form the first “BioNTainer, — a pop-up mRNA vaccine manufacturing line packaged in the containers — donated by BioNTech, the maker of the mRNA technology in Pfizer’s COVID vaccine. The modular site is intended to form the core of a new vaccine manufacturing center. It will be staffed by Europeans for the first five years, according to BioNTech.

Two more companies — Biogeneric Pharma in Egypt, which will receive an mRNA technology transfer from Afrigen, and Sensyo Pharmatech in Morocco — have received significant investment to expand their production. And in Kenya, the government is having the Kenya BioVax Institute switch from producing animal vaccines to making human ones. It has tapped Dr Michael Lusiola, an expatriate Kenyan who was a senior executive with AstraZeneca in the United Kingdom, to come home and run it.

Nguyen, the Gavi officer, said that having the ability to make large numbers of vaccines would help to give Africa security in case of another pandemic. She said the continent could build that capacity while making routine vaccines for the African market.

Nguyen said she was encouraged by the number of African initiatives that were embracing new technologies that would allow them to “leapfrog.” In the past, making vaccines required a huge physical footprint, so that meant producing huge volumes to pay for it.

“Having a small unit that can get up and running and do 5 or 10 million doses and then switch to something else — I think that really changes the established marketplace,” she said.

Many of the new initiatives are heavily dependent on philanthropic funding, much of it from the Bill & Melinda Gates Foundation and the multilateral Coalition for Epidemic Preparedness Innovations, as well as low-cost bilateral loans. It’s not clear how long that enthusiasm will last. Martin Friede, who leads the vaccine research unit at the WHO, predicted “the COVID guilt will be over by this afternoon.” He added, “I just don’t see South Africa agreeing to buy vaccines from Nigeria at a higher price than vaccines from India or Europe. That’s a tough ask.”