Increasing the manufacturing capacity for COVID-19 vaccines in Africa could help ensure that the continent doesn’t “have to beg for vaccines when there is an outbreak,” said William Ampofo, chair of the African Vaccine Manufacturing Initiative.
But a wide-scale increase in production won’t be simple, vaccine manufacturing experts said. Currently, African nations only produce 1% of the vaccines used on the continent, with scattered, limited capacity.
Some of the barriers to quickly ramping up production include inadequate incentives for investment, skills gaps, weak regulatory environments, and unknowns around long-term demand for COVID-19 vaccines.
“It is a very tall order to start looking at significant manufacturing on the continent,” said Greg Perry, assistant director general at the International Federation of Pharmaceutical Manufacturers & Associations.
Beyond intellectual property
There is a global push for pharmaceutical companies to waive intellectual property rights and provide the expertise in producing vaccines to a broad base of manufacturers. At a recent World Trade Organization General Council meeting, activists fought for a proposal that would suspend intellectual property protections around COVID-19 vaccines and treatments. But it fell short without support from high-income countries.
Some experts say that even if this were to pass, barriers to widespread production of COVID-19 vaccines in Africa go beyond intellectual property.
So far, solutions for expanding manufacturing have included some instances of pharmaceutical companies transferring the know-how and rights for a vaccine’s production to other companies, such as AstraZeneca allowing the Serum Institute of India and South Korea's SK BioScience to produce its vaccine.
“You can build all of this [capacity], but if you are not able to maintain production and not able to maintain demand, you're going to end up with a lot of dormant manufacturing sites.”— Greg Perry, assistant director general, International Federation of Pharmaceutical Manufacturers & Associations
But knowledge transfer alone will not solve the problem of ramping up manufacturing in Africa, AVMI’s Ampofo said at a recent press briefing, adding that “if it could happen, it would have happened.” Major stumbling blocks, such as inadequate financing, stand in the way of increased production.
Even with these barriers, it’s still important to remove intellectual property barriers, according to Anna Marriott, health policy manager at Oxfam. She said this “removes any doubt as to whether or not an IP barrier exists and enables governments, companies, and civil society to focus on overcoming other challenges to introducing and scaling up manufacturing."
Long-term demand and investment gaps
According to Ampofo, countries already producing vaccines include South Africa, Morocco, Tunisia, Egypt, and Senegal.
South Africa’s Aspen Pharmacare signed an agreement with Johnson & Johnson for involvement in the last stages of producing its COVID-19 vaccine. Biovac, another South African company, signed an agreement with ImmunityBio to locally manufacture a second-generation vaccine, but it is still in clinical trials. And this month, Egypt aims to finalize an agreement between its Holding Company for Biological Products & Vaccines and China’s Sinovac Biotech to manufacture a vaccine.
But not every country is ready to move forward with an agreement. Vaccine manufacturing is a complex process requiring unique equipment for each stage and for each type of vaccine, as well as strict quality standards and highly trained employees. And just because a country has existing capacity doesn’t mean it can easily retrofit a plant to produce COVID-19 vaccines, IFPMA’s Perry said, adding that resources at facilities across Africa are often already devoted to other vaccines.
Vaccine production requires high upfront investments, but there aren’t enough incentives to invest because of uncertainty around long-term sustainability, said Dr. Githinji Gitahi, CEO at Amref Health Africa.
Right now, there are shortages of COVID-19 vaccines globally, but there could be excesses later as more people are inoculated. Unknowns around the need for vaccines in the future include the effectiveness against new variants of the coronavirus, the length of protection that inoculation offers, and whether booster shots are needed.
“You can build all of this [capacity], but if you are not able to maintain production and not able to maintain demand, you're going to end up with a lot of dormant manufacturing sites,” Perry said.
Starting in 2005, the World Health Organization worked to expand production capacity for pandemic influenza vaccines in 14 countries, including Egypt and South Africa, for over a decade. But the high cost of production relative to demand shuttered many plants.
“When you look at sustainability, it's not such a rosy picture. Many of those facilities are either already shut down or at risk of being shut down,” said WHO Chief Scientist Soumya Swaminathan at a recent conference.
The continent also has segmented markets, with many countries and small economies, Gitahi said. Vaccines are often produced in large quantities at low prices, creating the necessity for large markets.
A bid to relax intellectual property rules while the pandemic rages still lacks the support it needs from the world's wealthiest nations.
“If you talk to the private sector, they share the sentiments of having investments in Africa for Africans,” said Ama Pokuaa Fenny, health economist at the University of Ghana’s Institute of Statistical, Social and Economic Research. “But they will only do it if they are assured of markets — not just small markets, but big markets.”
Global shortages and urgent needs
Even without these barriers, there are global shortages around materials, such as vials and stoppers, needed to manufacture vaccines. The United States banned the export of filters and bags, among others, to ramp up domestic production. Because of this, scaling up the number of manufacturers fighting for the same supplies might not make sense.
“Are they going to have access to the vials, syringes, and the raw materials when even the existing manufacturers are having problems?” Perry asked. “You might have just more manufacturers competing over the same number of limited resources.”
And local manufacturing may not necessarily ensure vaccines are distributed locally. Discussions around Aspen Pharmacare producing vaccines in South Africa revealed that local markets won’t be given priority, as Johnson & Johnson already has advance market commitments in other parts of the world, Gitahi said.
And given the urgency of the situation, there is a need to produce COVID-19 vaccines quickly.
“The discussion for COVID-19 specifically is: How do you ensure vaccines are available as soon as possible?” said Sai Prasad, president at the Developing Countries Vaccine Manufacturers Network, during a recent press conference.
“Maybe we should think about building it [COVID-19 vaccine production capacity] in the years to come. But you know, during 2021 and maybe early 2022, we need to go to where the existing capacities are, existing expertise is, existing human resources are.”
Rather than increasing the number of vaccine producers in African countries, regional hubs are a better option, said Perrer Tosso, senior manager for advanced manufacturing technologies at U.S. Pharmacopeia. Increasing the number of countries involved in the final stages of filling vials and packaging them — referred to as “fill and finish” — is a good start.
“We really need to look at the current system and see how we can review it and reshape it so that this complex issue of vaccine manufacturing, which requires huge financial investments and a long-term vision, is actually established now,” AVMI’s Ampofo said.