CEPI-hosted collaborative to bridge regional vaccine manufacturing

A stark lesson that arose from the inequities experienced during the COVID-19 pandemic was that low- and middle-income countries were far too dependent on pharmaceutical products from foreign companies. Wealthy countries hoarded supplies, leading to long delays in receiving lifesaving commodities like vaccines and drugs in other parts of the world. To change this, there’s been a call for heightened levels of pharmaceutical manufacturing in lower-income countries — but not to do so haphazardly, instead to move forward with a strategic, regional approach. This is aimed at ensuring there aren’t duplication of efforts, wasted resources, and that efforts are actually profitable. It doesn't make sense, for example, for every country in Africa to set up a vaccine manufacturing plant. Not every country has the capacity and some would fail because there wouldn’t be enough purchasers of their product. Instead, certain countries would manufacture and supply the continent. Some may produce the actual vaccines while others may produce input materials like filters or vials. But there are also challenges in executing a regional approach. This includes ensuring political agreements for regional cooperation are in place, ensuring the workforce is trained, that there is a conducive regulatory environment, and sustainable business models. And it's in this context that the World Economic Forum initially formed the Regionalized Vaccine Manufacturing Collaborative, or RVMC, in 2022. Since then, it's been primarily engaging with public and private partners in Africa and Latin America. And at the end of last year, there was a push for this collaboration to continue — and for the Coalition for Epidemic Preparedness Innovations, or CEPI, to take a more active role in it. The collaboration is now in its second phase and becoming more formalized. CEPI is establishing and hosting a small secretariat, which probably won’t exceed eight people, said Dr. Frederik Kristensen, managing director of the RVMC. The initial lifetime of this initiative is set for three years. “There's a perceived need for something like this now, with all the initiative and all the energy, and all the cash actually being poured into this,” he said. Its mandate is to support existing regional vaccine manufacturing initiatives — creating more alignment than what’s currently happening. This includes serving as a network to bridge the different regions so they can share lessons and technical knowledge with one another. It’s expected that its priorities will include advocating for political and financial commitments, providing a convening platform, supplying data and independent advice on how to create sustainable businesses and markets, and accounting for progress that has been made. The RVMC established an executive committee with members such as Africa Centres for Disease Control and Prevention Director-General Dr. Jean Kaseya, Pan American Health Organization Director Jarbas Barbosa, CEPI CEO Richard Hatchett, National Academy of Medicine President Victor Dzau, WEF Head of Health and Healthcare Shyam Bishen, and Farid Fezoua, the global director of health and education at the World Bank Group’s International Finance Corporation. Kristensen said the collaborative will particularly focus on regions left behind during the COVD-19 pandemic, including Africa, Latin America, and Southeast Asia — and there is also interest from the Middle East. The African continent has made a lot of progress in regional manufacturing efforts in recent years, with high levels of commitment from the African Union. The AU has the Platform for Harmonized African Health Products Manufacturing that is working to coordinate efforts across the continent and ensure they’re strategic — for example supporting manufacturing projects in South Africa, Rwanda, and Senegal. Its goal is that the continent manufactures 60% of the vaccines it uses by 2040. Additionally, there’s also Gavi, the Vaccine Alliance’s new African Vaccine Manufacturing Accelerator — which will make up to $1 billion available over a decade to support the nascent sector. PAHO has also coordinated efforts to increase vaccine manufacturing in Latin America and the Caribbean. In terms of comparing the two regions, and what they can learn from one another, Latin America has some manufacturers that are quite advanced and more established than what exists on the African continent, Kristensen said. The African continent, on the other hand, has less of that technical base but has a more clearly defined road map. Experts say that a key enabler of ensuring the sustainability of local manufacturing is when regional pooled procurement mechanisms commit to buying from local manufacturers when possible — as opposed to purchasing from abroad. Latin America has a revolving fund for pooled procurement of vaccines with decades of experience, which makes them 75% cheaper than if a country were to purchase them on their own. “That pooled procurement is not necessarily to buy products from Latin America — it's to buy products for Latin America,” Kristensen said. “They procure most of their vaccines outside of the region.” African governments have also agreed this year to create a pooled procurement mechanism for medical commodities on the continent. Kristensen said that RVCM can serve as a platform where regional players can discuss “how to best structure procurement mechanisms to balance different objectives.” This includes looking at things like quality, price, and a supplier’s track record for timely delivery. “My sense is that particularly the price/cost element will have to be balanced against any criterion to support regionally based manufacturers — at least until costs have come down over time thanks to increased volumes etc.,” he wrote. The work of the collaborative will seek to support concrete requests from the regions, including on technical assistance, Kristensen said. For example, leaders in Africa have asked for a platform where different countries engaged in vaccine manufacturing can come together and compare notes. Another need is support in increasing the production of drug substances — because many of the manufacturing initiatives in Africa have been focused on the fill-and-finish process, which is the end stage of manufacturing that does little to increase health security for the continent. In Latin America, there’s a desire for an updated overview of the different initiatives across the region and the development of a platform to help integrate discussions around these initiatives. PAHO is also considering ways to evolve its pooled procurement mechanisms strategically, and is interested in learning from other regions, Kristensen said. The collaborative has a small amount of resources it can use to provide concrete technical assistance on some projects — but funding is not its mandate so those resources would need to serve as a catalyst, he said. A considerable part of the RVMC’s focus will be on helping ensure markets are healthy and that new initiatives are sustainable from a business perspective. “How are those initiatives going to be sustainable for the long run?” Kristensen asked. “I think the jury's still out on that.” He said that includes a focus on manufacturing for routine vaccinations. For example, there’s currently not sufficient market demand for COVID-19 vaccines, Kristensen said. Moderna recently announced that it is backing out of its plans to build a messenger RNA manufacturing plant in Kenya because the demand for COVID-19 vaccines has declined to a point that’s "insufficient to support the viability of the factory." But the second phase of the RVMC collaborative is still in its early days, Kristensen said. It’s still working to understand the landscape of manufacturing activities in the regions and determining where their efforts can make the most impact. “How does the platform operate? And how do we really promote the catalyst roles, and accelerating roles, and the matchmaking roles? That is still being worked on,” he said. Kristensen said that a regional manufacturing approach will be more expensive for a period of time — as opposed to relying on existing global markets. “Countries and partners need to be willing to pay a premium for increased health security and long term industry and ecosystem development,” he said. Update, June 13 and 14, 2024: This article’s headline has been updated and the article updated to include that Shyam Bishen, the head of health and health care at WEF, is part of the RMVC executive committee.