mRNA vaccine production on African soil was first pledged to the Rwandan and Senegalese governments in May 2021. Now, almost a year later, that promise has finally been fulfilled in the shape of two beige shipping containers, within which is a laboratory sophisticated enough to follow BioNTech’s 50,000-step production process and the prospect of greater vaccination access for millions of Africans.

mRNA vaccines, heralded by the journal Nature as a “new era in vaccinology”, work by delivering a genetic molecule into a cell, encoding it to produce the relevant antigen to destroy live virus particles. The versatility and speed at which vaccines can be developed through mRNA technology mean the potential uses are widespread. 

The ‘laboratory in a container’ from German biotech giant BioNTech was unveiled at its Marburg site, where 1.2 billion vaccine doses were produced in 2021. ‘BioNTainers’ will eventually be shipped overseas and staffed by local partners, producing up to 50 million doses of a vaccine for the African Union at a not-for-profit price.

Boosting capacity

In the midst of a pandemic, there was an obvious need for African countries to get access to more vaccines at a reduced cost relative to Western markets, says Anne Dhulesia, partner and member of the life sciences practice at LEK Consulting. Currently, 11% of Africans are fully vaccinated against Covid-19, according to the WHO, requiring the vaccination rate to increase six times to meet the continent’s 70% immunisation target by the middle of 2022.

Ms Dhulesia says investment in domestic manufacturing capacity to produce these vaccines is one way to address this challenge.  

“The use of modular manufacturing could be a helpful entry point into the African market, potentially with larger, more traditional facilities following later,” she says, adding that mRNA vaccines, which have only recently been made available to the public on the back of the Covid-19 pandemic, require smaller bioreactors and hence a smaller footprint than other modalities, such as antibodies.

“Modular facilities are potentially more versatile, therefore providing long-term optionality. They may be faster to set up, potentially at a lower cost, while still providing the quality expected for the end product,” Ms Dhulesia says.

The potential of modular facilities has also caught the attention of US pharmaceutical giant Moderna, which in March announced plans to establish a similar facility in Kenya.

Developing local know-how

Yet vaccine availability is just one of the issues facing healthcare in Africa, says Dr Markus Manns, senior portfolio manager at Union Investment, who argues that vaccine hesitancy and shortcomings in the infrastructure needed to deliver vaccinations are the more pressing issues. 

“Despite the low vaccination rate in Africa, affordable vaccines seem to be the least of the problem,” Dr Manns says, citing cases where countries have not been able to use up donated vaccines or have had to cancel vaccine imports – about 100 million doses distributed by global programme Covax were rejected in December alone due to their short shelf life, a Unicef official told the European Parliament in January. The lack of widespread cold chain infrastructure compounds the issue. 

In the future, the modular facilities could be used to make mRNA vaccines targeting other diseases, such as tuberculosis or malaria, depending on future medical needs and development progress. According to its own website, BioNTech currently has a number of mRNA-based candidates in its pipeline.

Anton Gerdenitsch, global head of contract manufacturing at Novartis, says a typical vaccine manufacturing plant requires two or three years of development and a “certain infrastructure” consisting of experienced service contractors, equipment suppliers and a “workforce with a very specific know-how”.

“Normally, this infrastructure can only be found around pharma-clusters in highly industrialised countries. In Africa, it would really depend on where this could be and would need a focused approach with a significant investment, not only monetary but also timewise,” he says.

While the modular approach may “expedite the set-up of vaccine facilities”, it doesn’t build up the required local expertise to run and operate these facilities in a similar timeframe.

“It will, depending on the countries we look at potentially, make the African countries very dependent on the designers of the modules,” says Mr Gerdenitsch. “If the local teams have not been involved in designing and building the facility, and had no chance to build up the required know-how, it is more difficult for them to maintain and operate it. In addition, if no local suppliers or locally available parts were used for building these modules, it makes maintenance more difficult.”

BioNTech intends to run its facility autonomously at first before training local staff to take over. However, there are “countless examples of well-designed equipment and facilities which were imported to foreign countries and simply couldn’t be maintained there”, adds Mr Gerdenitsch, a factor that may be vital to the long-term success of the modular programme.

Reputational side-effects

For the German biotech giant, mRNA-based modalities are only part of a broader strategy to capitalise on the surging demand for novel therapies. Whereas rival Moderna is fast-expanding its own pipeline of mRNA therapies, BioNTech’s approach is rooted in mRNA as well as small molecule immunomodulators, T-cell receptor engineering therapies for treating cancers, antibodies and biologics.

While the modular mRNA facilities in Africa may have “little effect on sales numbers and profits”, it will have a sizeable effect on BioNTech’s reputation and the way it “thinks about its responsibility towards society”, says Dr Manns. 

“ESG [environmental, social and governance] has become more and more important for investors, and access to healthcare for the developing world is a big contributor to a positive ESG score. BioNTech not only contributes to this by giving vaccines away at manufacturing costs but also contributes to the independent supply, by providing the modular manufacturing containers for local manufacturing,” Dr Manns adds.

Looking ahead, the introduction of BioNTainers, the development of a skilled domestic workforce and the integration into local health ecosystems may allow for BioNTech to have a greater influence over future treatments.

It is unclear how much BioNTech can reduce manufacturing costs by producing in Africa, but Dr Manns says it has the potential to become an advantage over competitors in the long term, especially if mRNA treatments for tuberculosis or malaria vaccines are successful. 

There is an evident need to promote vaccines in Africa, and while BioNTech investors may be appeased by the scalability of the programme, building and maintaining the required infrastructure may make the 50,000-step manufacturing process look trivial in comparison.

This article first appeared in the April/May 2022 print edition of fDi Intelligence.