Vaccine manufacturing in Africa needs a ‘business case’
Africa produces 1% of the vaccines it needs. This is while using 25% of all vaccines produced globally. Some countries have begun building their vaccine manufacturing capacity, but transparency and coordination between regions will be needed to ensure a sustainable sector on the continent.
If Africa is to reach self-sufficiency when it comes to the manufacturing of vaccines, it is vital that the development of vaccine manufacturing facilities across the continent is transparent and coordinated.
The Partnership for African Vaccine Manufacturing and the African Centre for Disease Control play a vital role in the monitoring of such development, says Dr Sam Machour, executive vice president and chief quality officer at Samsung Biologics.
While healthy competition is needed between countries, a failure to develop a vaccine manufacturing strategy could result in too many countries producing the same vaccines, thus outstripping demand and putting the success of these ventures at risk, he said.
“We’ve learnt that the hard way so many times,” said Machour. “If we don’t do it right this time, then we’re back to each country doing it for themselves, and it’s not viable long term… we might end up with excess capacity all over the place, or manufacturing vaccines that we don’t use.”
Machour was speaking at a roundtable discussion on “Opportunities for drug substance manufacturing in Africa”, hosted on 13 April by the Nelson Mandela School of Public Governance. The discussion was chaired by Kirti Narsai, principal researcher at the school.
Other speakers in attendance were Dr Simon Agwale, CEO of Innovative Biotech in Nigeria; Prof Petro Terblanche, managing director of Afrigen Biologics; Youssef Gaabouri, associate director and head of sales for the Middle East and Africa in the bioprocessing division at Merck; and David Lindholm, head of global business development at KeyPlants.
The African continent produces 1% of the vaccines it needs, although it uses 25% of all vaccines produced globally, according to Terblanche. Prior to 2020, there was very little capacity and capability on the continent for drug substance production or fill-finish for vaccines.
Through the Partnership for African Vaccine Manufacturing, African roleplayers have set the target of enabling Africa to manufacture 60% of its vaccine needs locally by 2040, according to Agwale. This will mean developing the manufacturing capacity to produce at least 1.5 billion vaccine doses a year. The various plans in progress to put vaccine manufacturing facilities on the ground are projected to produce 4.5 billion doses a year.
Agwale argued that it was important to consider the business case for, and potential profitability of, vaccine production at these facilities. His own company is seeking to fill a gap by developing new vaccines relevant to the African continent.
“There should be a reason for developing… for going into a venture. Not just ‘me too’ initiatives — it’s not going to help the continent,” said Agwale.
When it comes to the business case for vaccine manufacturing, there is a role for governments across Africa to play, according to Machour. Vaccines are a matter of national security, he said, in that they are key in preventing the type of disease-related event that could quickly flatten a country’s economy.
“Of course, you need a business plan because without a business plan, if you are in the industry, you will go belly up pretty quickly,” he said. “But this is where governments — especially when we’re talking about vaccines — have to pitch in with a different kind of business plan, which is security and safety of [their] nations in the economy.”
In Morocco, said Machour, the business case for developing vaccine manufacturing capabilities was brought to the fore by the impact of the Covid-19 pandemic. Morocco imports all its vaccines, having no manufacturing capacity of its own. The country spent more than $800-million on the procurement of Covid vaccines. Due to border closures, some of those doses were never even received.
Subsequent efforts to start building vaccine manufacturing capabilities were driven by “top-down initiatives” from Moroccan King Mohammed VI, said Machour. As such, the business case for the venture was built not on profitability, but on national security.
There was a further instruction from the king to support Africa in the self-sufficiency momentum being built for vaccine manufacturing. The development of vaccine manufacturing capacity in Morocco was intended to contribute to self-sufficiency both within the country and across the continent, explained Machour.
A facility will be opening in Morocco at the end of July 2022, with an initial production capacity of 150 million doses of fill-finish vaccines. This will go up to 5oo million in 2023 and 900 million in 2025, he said.
Morocco is working to in-licence a portfolio of 20 vaccines to be produced as part of this initiative. Once vaccines are registered and produced within the country, the Moroccan government has committed to procuring all its vaccine needs locally.
“So… the government commits to automatically replace anything it imports, and give preference to local manufacturing, to local fill-finish,” said Machour.
Preferential procurement “de-risks” vaccine manufacturing projects, according to Prof Terblanche.
“If the continent can get that, we will build the network that will sustain and reach the goal of at least 60% of our vaccines supplied by ourselves,” she continued.
“I hope that more governments will look at: what are the policy environments that will enable preferential procurement for the locally produced vaccines?”
Afrigen Biologics in South Africa has been involved in designing an mRNA Covid-19 vaccine, according to Terblanche. At this stage, the team has a lab-scale proof-of-concept vaccine candidate, which will be prepared for clinical development. The target product profile is focused on the current pandemic and finding a suitable vaccine candidate to be used as a booster.
The process of developing this vaccine candidate involved technology transfer. Access to existing technology and information is particularly important on the African continent, due to the long-standing absence of a viable drug manufacturing sector, said Terblanche.
Afrigen worked with Wits University, benefiting from the specialised knowledge made accessible through the institution. They further accessed what relevant information was available in the public domain, she said.
“I think the collaboration is not only with tech transfer providers, but should also come from the local academic universities, and to see how they can integrate in their… university programme, training programme, biotech activities, biotech training, to make sure that the people are going to be ready to run such [drug manufacturing] facilities,” said Youssef Gaabouri.
There are great minds at African universities that can contribute to the development of vaccine manufacturing capacity on the continent, said Machour. To “level up” this sector, talent will be required in areas such as regulation, manufacturing and analytical testing.
“This is a rethinking of the public-private partnerships on how to build an entire value chain, and talent is an absolutely essential part that cannot be forgotten,” he said.
“We have capabilities… we need to scale up those capabilities and work together.” DM/MC