Global south watches as South Africa's Aspen ventures into vaccines

Aspen Pharmacare, a pioneer of local, private pharmaceutical production in Africa, is moving more firmly into vaccines. Champions of local production in the global south are watching. Having inked a 10-year deal in 2022 with the India-based Serum Institute, Aspen will manufacture and distribute four vaccines across Africa, though a timeline for distribution is not yet set. In December, Aspen announced it is also getting support for vaccine development from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations to the tune of $30 million. The agreements, Aspen’s Senior Executive for Strategic Trade Development Stavros Nicolaou told Devex, are a response to the imbalance in access to COVID-19 vaccines and the resulting call from the African Union for more than 60% of the continent’s vaccine supply to be developed, produced, and supplied by African manufacturers by 2040. The continent currently imports 99% of its vaccines. “Ultimately, the proof will be in the pudding in terms of whether we start seeing regional procurement mechanisms put into place.” --— Stavros Nicolaou, senior executive for strategic trade development, Aspen Pharmacare “It's really hardened the resolve of Africa to establish its own capabilities, its own capacities,” Nicolaou said. Other African manufacturers and potential investors are waiting to see if Aspen can develop a viable model for vaccine manufacturing, and if the company can help usher in a more favorable landscape for production across the continent. That would include helping to foster a more harmonized regulatory environment, pushing for more favorable government policies, and helping address an entrenched procurement system that takes little account of African producers. Using leverage “Aspen Pharmacare is a titan of the African pharmaceutical production landscape,” Lenias Hwenda, founder and CEO of Medicines for Africa, told Devex in an email. “It is the most successful and most globalized pharmaceutical company originating on the African continent and now has the capacity to serve patients around the world.” Founded in 1997 as HIV rates in South Africa were exploding, Aspen leveraged activist pressure for affordable access to compel pharmaceutical giants to grant the company voluntary licenses for antiretroviral medications. That allowed Aspen to produce cheap versions of emerging anti-AIDS drugs. “They were able to progressively use those early partnerships to enter into licensing agreements that helped them to grow their manufacturing business to eventually start manufacturing their own branded products,” Hwenda explained. Aspen, which now has 23 manufacturing facilities across 15 sites, reported more than R38.6 billion in revenue last year, producing both commercial products and niche medicines, like thrombosis therapies. When COVID-19 emerged, the company was able to rapidly transform a site in Gqeberha, South Africa, into a facility for filling and finishing Johnson & Johnson’s vaccine. Nicolaou said that Aspen manufactured 230 million contract doses of the J&J vaccine. That experience was not without controversy, including reports that the bulk of the early doses Aspen produced was sent to countries outside of Africa even as vaccination rates on the continent trailed other parts of the world. That underscored the global imbalance resulting from the lack of research and development capacity throughout Africa. While Aspen was hired to bottle and package the vaccine, it did not have control of the patent and, ultimately, how the jabs were distributed. Nicolaou said the vast majority of the COVID-19 vaccines that Aspen eventually produced stayed on the continent. Nevertheless, that experience underscored calls from activist groups for greater investment in R&D capacity so that African companies will not always be dependent on striking deals with pharmaceutical giants in the global north. Internal and external challenges Nicolaou said the Serum deal might be a step toward that reality. Though it is a fill-and-finish agreement for the pneumococcal, rotavirus, polyvalent meningococcal, and hexavalent vaccines, it should allow Aspen to begin building out its vaccine production capacity. There is not yet a date when the vaccines will be available, but he said the company was currently receiving the necessary technology from Serum and attending to the various regulatory processes. In addition to increasing continental access to the four vaccines, that capacity alongside the Gates Foundation and CEPI money should also give the company the flexibility to pivot to producing immunizations in the midst of any future crisis. “It helps us balance portfolios between outbreak vaccines and routine vaccines and bridging that gap,” Nicolaou said. The hurdles to reaching local product development are not all internal, he cautioned. Among those broader challenges include harmonizing regional and continental regulatory processes, an effort that is already underway with the development of the African Medicines Agency. Nicolaou also called for ongoing access to a pipeline of products, which will allow global south manufacturers to increase their knowledge and capacity. The biggest challenge, though, is ensuring there is a market for whatever vaccines — or any other medicines — that are ultimately produced in the global south. Aspen is familiar with this problem. In March, the company struck a deal to produce and sell its own version of the J&J vaccine — Aspenovax — only for demand never to materialize. By August, the company was announcing plans to shut down the production line because it had not received enough orders, though Nicolaou said they still have the capacity to restart production if the need arises. Moving forward, he said officials would need to think strategically about where and how to place production facilities to make sure there was not an oversupply of any products. That has raised some concern among activists, who worry that imposing too many limitations could essentially maintain a monopoly that allows private companies to keep prices artificially high. Candice Sehoma, Médecins Sans Frontières’ access campaign advocacy advisor, also cautioned that the public has little leverage over agreements made with private companies. In countries where the government does not exercise significant oversight or attach access conditions, it may lead to situations where a company is allowed to place profit over public interest. If they do, it may cause global donors, who provide a significant portion of the vaccines for the global south, to ignore emerging manufacturers in their procurement. Local manufacturers remain worried that, no matter what price they set, they will be overlooked as international agencies procure future vaccines. “Ultimately, the proof will be in the pudding in terms of whether we start seeing regional procurement mechanisms put into place,” Nicolaou said. Gavi, the Vaccine Alliance, has already announced plans to change its procurement process to include more African manufacturers. And as more supplies are produced in the global south, it may become easier to convince other donors to follow suit. If the donation models allowed for funds donated to also buy medical products from local manufacturers, then it would create enormous value for companies manufacturing locally on the African continent, Hwenda said. “Which in turn would support sustainable industrial development of Africa’s pharmaceutical sector and ensure security of supply of medical products on the continent,” she added.