Painstaking progress in African vaccine manufacturing

By this December the German immunotherapy company BioNTech expects to begin evaluating manufacturing equipment that it has installed in a modular clean room set up in six eight-foot by 40-foot shipping containers in Kigali, Rwanda. The company, which together with Pfizer developed and launched one of the two mRNA-based COVID-19 vaccines, intends these shipping containers to become mRNA vaccine-manufacturing hubs capable of producing more than 50 million COVID-19 vaccine doses a year, the first in what it describes as a node in a decentralized, robust, end-to-end manufacturing network in Africa.

“That’s not the solution for all vaccine manufacturing on the continent,” said BioNTech chief operating officer Sierk Poetting. But it is progress. And given the vastly delayed and sluggish rollout of COVID-19 vaccines in all but the wealthiest countries, this type of manufacturing hub could make a difference now or in the next pandemic.

“We are trying to be one puzzle piece that fits into this bigger system,” added Poetting, who spoke at a panel at the recent World Health Summit, held from October 15-17 in Berlin, Germany. The Summit itself has become an increasingly prominent forum in public health circles in recent years — even pre-pandemic — given increased German underwriting of public health initiatives and institutions, and the fact that Berlin is home to the World Health Organization’s (WHO) Pandemic and Epidemic Intelligence Hub.

This year’s Summit was held at an unsettled time marked by war and growing concern over the health effects of climate change — critical issues that are battling for the world’s attention. But there is also a strong desire not to lose momentum for implementing improvements in the public health landscape spurred by the COVID-19 pandemic, including, but certainly not limited to, expanding the capacity to manufacture and deliver vaccines within low-income countries.

The clamor for more local and locally controlled vaccine manufacturing capabilities and shorter supply chains reached new heights during the COVID-19 pandemic, not only in Africa but especially there. Vaccine procurement and delivery came much later to sub-Saharan Africa than to wealthier parts of the world, prompting outrage.

It was made even worse when doses produced by Serum Institute of India — by far the largest manufacturer of vaccine supply to the global South — was directed to halt exports during the time a brutal wave of COVID-19 crested in India over the course of five months in 2021.

Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers and Associations, said investing now in diversity of manufacturing is essential. “We have to find a way,” he said, referring to John Nkengasong’s call for action when he was head of the African Centers for Disease Control and Prevention (he is now Global AIDS Coordinator in the U.S. State Department). Nkengasong oversaw a pledge from African leaders to increase the share of vaccines manufactured on the continent to 60 percent by 2040. The continent currently imports 99 percent of its vaccines and 95 percent of its medicines.

This looks set to remain a thorny issue for some time. Reaction among researchers and others in the public health community has been decidedly mixed to BioNTech’s modular manufacturing initiative. Some have criticized this approach for being merely a ‘black box’ without the wholesale technology transfer that would include the intellectual property to manufacture the vaccines that many would like to see shared more broadly.

For its part, BioNTech now has 18 local staff in Kigali for its facility there. The company is also engaging with local regulators like Emile Bienvenu, director of the Rwanda Food and Drug Authority, who envisions the country as a regional healthcare hub.

Other efforts are also underway. The WHO is coordinating ongoing efforts to support Afrigen and Biovac in Cape Town, South Africa, as seed institutions to diversify vaccine manufacturing on the continent.

As these efforts mature, there will likely be many challenges. One is unstable infrastructure. Another is making vaccine manufacturing on the continent sustainable for the long term, as was sharply pointed out at the Summit by Ayoade Alakija, former chief humanitarian officer in Nigeria and co-chair of the African Union’s African Vaccine Delivery Alliance. “Who’s going to buy the vaccine?” she asked. “What we are talking about now with this disproportionate focus on everybody on the continent wanting to manufacture vaccines is a money sink, unfortunately,” Alakija said. “We should really be investing in our health systems.”

Strengthening health systems will be particularly critical as new pathogens emerge. Publicly on panels and privately in the hallways, several Summit attendees drew attention to another large-scale concern for pandemic risk and preparedness: the way humans are interacting with animals, particularly with birds and livestock, as habitats for people and domesticated animals shift and encroach on the wild within environments buffeted by the effects of climate change.

“West Africa is acting like a sink for avian influenza within the Eurasian flyway,” said Dorothy Yeboah-Manu of the University of Ghana. She and a group of experts charted the multicontinental spread of different strains of avian flu among wild and domesticated birds. Highly pathogenic avian influenza overall has resulted in the death and culling of more than 500 million poultry worldwide between 2005 and 2022.

Currently it is a very rare occurrence that bird flu makes the jump from animal to human — approximately 850 cases were reported from 2003 to 2016, according to Hiroshi Nishiura, an epidemiologist at Kyoto University. But it is dangerous: of those 850 cases, 449 resulted in death.

As migration patterns change, it increases the kinds of mixing and contact that wild birds have with domesticated fowl, which is one way that new flu strains develop. Bird flu viruses also appear to be originating in different parts of the world. The epicenter of avian flu outbreaks is historically in Asia, but over the last three years, new H5 influenza viruses developed within African poultry and among European wild birds.

Azizul Haque, a microbiologist and immunologist at the Geisel School of Medicine in Dartmouth, published a perspective more than a decade ago calling for more research into preventive vaccines against avian flu. He sees rising apprehension about a more contagious variant of H5N1 among birds. Whether the virus could evolve enough to move from bird to human and then become capable of human to human transmission is unclear, but it’s enough of a worry that vaccine makers are developing or testing candidates matching the avian flu subtype as a precaution.

Christian Drosten, one of the leading German virologists during the COVID-19 pandemic and deputy coordinator for emerging infections at Berlin’s Charite Research Center, also called for better surveillance: not of wild animals, but of domesticated livestock.

“Every respiratory pandemic virus that we know of historically came through livestock, and we are ignoring that fact,” Drosten said. “Ecology, yes. We know viruses come from some wildlife hosts. But contact between this host and humankind is often if not always via livestock.”

He listed influenza and coronaviruses, including MERS, as present concerns. “We have to invest in livestock surveillance. We are not speaking about research, but about surveillance,” he said. “This is much more important. And much more expensive.”

Read more:

— Clinton Health Access Initiative report on current and planned vaccine manufacturing in Africa

— Africa CDC and Partnerships for African Vaccine Manufacturing

— WHO on ongoing avian influenza outbreaks in animals and risk to humans