German biotechnology giant BioNTech on Monday, December 18, inaugurated its first Africa site in Rwanda, in a move that was aimed at strengthening vaccine production capabilities, enhancing health security, and improving access to life-saving vaccines across the continent.

President Paul Kagame and First Lady Jeannette Kagame attended the event, which was also attended by several Heads of State and Government, as well as world leaders. The event took place at the 350,000 square metre facility located in the Kigali Special Economic Zone, a designated area for biopharma manufacturing in the country’s capital.

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While full commercial production is still slated for 2025, BioNTech said it was on track to complete the construction of all buildings at the Kigali site in 2024, citing plans to begin local training for specialised personnel and hiring about 100 staff, once fully operational.

At the launch, the new plant was described as a "crucial milestone” towards "Africa’s vaccine sovereignty”.

For context, Africa is the second most populous continent and carries 25 per cent of the global disease burden.

However, the continent imports 99 per cent of its vaccines and 95 per cent of its medicines.

Africa also consumes nearly 25 per cent of globally produced vaccines, which percentage will rise due to the expected 2.5 per cent yearly population growth.

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But what makes Rwanda’s BioNTech plant a crucial milestone?

The new BioNTech plant stretches across eight acres, but the heart is a concrete hall containing the modular lab, commonly known as the BioNTainer.

The first unit, made of six containers stacked three on three, will create the mRNA active ingredient.

Another unit, expected to be assembled alongside another eight containers early next year, will wrap the mRNA molecule in a protective lipid shell. The formulation will then have to be filled in vials elsewhere.

The units, BioNTech officials explained, are airtight and kept at a higher pressure than the surroundings to make sure no contamination gets in.

They may be sealed, but they are not self-contained. Just how many doses could be produced when the labs are up and running depends on the specifics of the vaccine, but it was highlighted that the initial production is estimated at 50 million jabs per year.

However, production is still some way off. BioNTech is embarking on finishing and installing the other containers. The first batches, expected, in 2025 will then need to be used to check quality control.

As it stands, BioNTech is developing preventive mRNA vaccines for illnesses such as tuberculosis, malaria, HIV, and diseases with epidemic and pandemic potential.

Clinical trials for tuberculosis and malaria vaccines are now underway, and the intention is to perform trials in Africa for malaria, tuberculosis, and HIV vaccine candidates in 2024.

According to Rose Leke, a professor of immunology at the University of Yaoundé, scientists have long pushed for local production of vaccines, but it wasn’t until Covid-19 gripped the world that biopharma companies began to more seriously consider partnerships with African countries.

"The pandemic gave us a rude wake-up call,” Leke stressed following the launch, adding that the borders were closed, and air transport was temporarily put on a halt, making international assistance even harder to come by. "Sometimes we cooperate in good times but in a crisis, people tend to look at their interests first.”

Leke reiterated that there are advantages to making vaccines in Africa specifically.

For example, she said, such vaccines may work better for local populations compared to imported ones due to differences in genetic makeup.

"And with 1.3 billion people on the African continent, there is a ready market. By manufacturing vaccines in three different African countries, BioNTech will establish economies of scale.”

Prof. Rose Leke recently won the award for ‘Achievement in Global Health Leadership’.

One partner BioNTech is working with is the African Biomanufacturing Institute (ABI), launched in June 2022 to train the workforce which currently boasts 20 staff.

"The institute’s purpose is to meet the growing demand for highly skilled individuals and attract local talent in STEM areas as well as those without exposure to academia in Rwanda and the African Union as a whole,” BioNTech officials said.

For San Bilal, an associate director of Sustainable Economies and Climate Action at the think tank Centre for Africa-Europe Relations, diversifying sources of vaccine manufacturing and moving towards strategic autonomy is critical for Africa’s industrialisation and the strengthening of its health sector.

Bilal argues that while importing medicines and vaccines will remain critical for Africa, it also limits the scope of the continent’s development of production capacity and technology transfer, which are important both for strengthening its health systems and economic development.

"Facilitating access to finance and investment for both African and international actors, ensuring an open African market, developing effective manufacturing and distribution logistics, and harmonising regulatory settings across African countries will be key to the African production of medical products,” he added; "It should also be accompanied by more comprehensive policies to strengthen Africa’s health systems.”

The sovereignty

Under the development, BioNTech retains its intellectual property (IP) but the host country polices distribution and export, according to the firm.

That would mean that in another pandemic-like crisis, Rwanda could use its export controls to have the final say on what was to be done with the vaccines, potentially prioritising its citizens and the region.

Pedro Alonso, BioNTech’s head of global health, said in an earlier interview: "When you export, it’s the country that gives you a license to export and where you are exporting to, so they do have control.”

He pointed out that it is also likely to give Rwanda a say on the vaccines produced.

Public health officials argue that vaccine sovereignty also needs more than a factory. They say that for a country to stand on its own two feet in vaccine production, it needs a whole ecosystem of different parts.

"That ranges from qualified scientific staff and a research base, to robust national regulatory systems, to readily available medical and chemical supplies.”