Important Lessons From the African Vaccine Manufacturer That Could Not Sell a Single Dose Pandemics & Emergencies 11/05/2023 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) South African President Cyril Ramaphosa visits Aspen Pharmacare’s manufacturing facility in Gqeberha. Regional vaccine production features in the draft pandemic accord, but there is still a long road before this becomes a reality Aspen Pharmacare invested millions of dollars in scaling up its South African production plant to make COVID-19 vaccines – yet it never sold a single vial. Meanwhile, in a “demoralising blow”, Bangladesh’s government rejected a vaccine developed by Professor Peter Hotez that was being made by a local company because it wasn’t an mRNA vaccine. While the pandemic accord currently being negotiated is almost certain to support regional vaccine production, setting this up is complex and the COVID-era failures offer a number of sobering and cautionary lessons. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Aspen’s Stavros Nicolaou, head of Strategic Trade, told a recent webinar hosted by Brown University’s Professor Wilmot James. While Nicolaou’s comment sounds mild, the body blow that his company took would have bankrupted a smaller company. Three key factors combined to undermine Aspen’s vaccines. First, despite the hype about the need for African-produced vaccines, African governments failed to buy the locally-made vaccines. Then Aspen became caught in a political stand-off between Africa and Europe about the fate of African-produced vaccines which delayed production by months. When that was eventually resolved, the world had fallen for mRNA vaccines and no longer wanted the viral vector vaccine that Aspen had been licensed to produce by Johnson & Johnson. Professor Peter Hotez Hotez, who directs the Texas Children’s Hospital Center For Vaccine Development, assisted to develop a viral vector vaccine concept. The Center then affected a technology transfer to Indian and Indonesian manufacturers that went on to make over 100 million doses, he told the seminar. But Bangladesh had passed over the vaccine, being made locally by a company called Incepta, in favour of the mRNA vaccines. Scaling up to make vaccines With the waning of COVID-19, maintaining countries’ and companies’ interest in building regional vaccine manufacturing ability is a challenge – and Aspen’s difficulties should be well noted. Aside from being Africa’s biggest pharmaceutical company, Aspen is also the leading manufacturer and supplier of general anaesthetics in the world outside of the US. Aspen’s main production facility, comprising six different manufacturing units, is in Gqeberha, an economically depressed city in one of the poorest regions in South Africa. Shortly before the pandemic, Aspen had invested around $400 million to expand its sterile capacities and volumes as it planned to relocate the production of some of its general anaesthetics and muscle blockers to Gqeberha. But when the company saw what was happening with COVID-19, it decided to switch to vaccine production. What followed, said Nicolaou, was “frenzied activity to try and acquire additional capacity” to enable its facility to make vaccines. In November 2020, Aspen announced that it had reached an agreement to “perform formulation, filling and secondary packaging” for Johnson & Johnson’s COVID-19 vaccine. The vaccine only needed one dose, it didn’t need ultra-cold storage and thus seemed to be the most “African-friendly vaccine”, said Nicolaou. President #Ramaphosa: In recognition of our country’s manufacturing capability one of the leading pharmaceutical companies in the world, Johnson & Johnson, has entered into an agreement with a local company, Aspen Pharmacare, to manufacture and package its candidate vaccine. — Presidency | South Africa 🇿🇦 (@PresidencyZA) November 11, 2020 The announcement was a source of national and continental pride, particularly as South Africa’s President Cyril Ramaphosa was chair of the African Union and spearheading the quest to get vaccines for the continent. But in August 2021, the New York Times exposed that millions of the J&J doses being produced in South Africa were being exported to Europe – at a time when only 7% of South Africans had been vaccinated. A political storm erupted. Ramaphosa intervened, appealing to the Europe Commission head Ursula von der Leyen to intervene. By September, European countries had agreed to return the J&J vaccines produced by Aspen for distribution in Africa. “There was a standoff between Europe and the African Union in terms of where these vaccines would finally land,” explained Nicolaou. “And it took quite significant negotiating and eventually, an agreement was settled between the EU and Africa for some of these vaccines, initially 60% and eventually 90%, to be retained on the African continent.” Aspen’s Stavros Nicolau By March 2022, J&J had licensed Aspen to produce and supply the vaccines under their own brand name, Aspenovax. Strive Masiyiwa, AU Special Envoy on COVID-19 and Head of the African Vaccine Acquisition Trust (AVAT), described the agreement as “the single biggest win for the African continent in the fight against COVID and future pandemics. It is a timely milestone and an important step in making sure that the gross vaccine inequality we witnessed in the early part of the pandemic is not repeated.” Aspen had expected to make 400 million vaccines. But the orders never came. Not a single one. By the time the agreement had been secured, Pfizer and Moderna had upped their production, and most African countries had opted for their mRNA vaccines which were being distributed by COVAX. “That was in November 2021 and demand had dropped off, and not a single Aspen COVID vaccine was produced thereafter. We called our product Aspenovax, and to date, we haven’t sold a single vial of Aspenovax. And that is the problem,” concluded Nicolaou plainly. After a few months of waiting with no orders materialising, Aspen was forced to close its production line. Stable and predictable demand “The first and most important element is we require a stable and predictable demand,” said Nicolaou, adding that there needed to be a proper procurement process through the African Union. Other important factors are an integrated regulatory system, the transfer of technology and knowledge to local African producers and public-private partnerships. For Hotez, his Texas Children’s Hospital Center For Vaccine Development disproved the belief that only big pharma companies “have the chops” to make vaccines. Nonetheless, Hotez says that “too often, those who are in the pharmaceutical space don’t differentiate between the challenges of producing vaccines at scale, compared to small molecule drugs or diagnostics or medical devices”. “The vaccine space is quite different, mostly because, when you’re talking about far more complicated biologics, the upfront investment is larger. The time horizons are longer and the risk is high as well. So it takes a very special type of biotech or pharma investor to invest in vaccines,” says Hotez. “People focus a lot on the patents and in my view, that’s in some ways, the least of it. It’s more the capacity building that can take years and years.” Lora du Moulin, Global Health and Security Lead at the World Economic Forum. Meanwhile, Lora du Moulin, Global Health and Security Lead at the World Economic Forum (WEF), told the webinar that the WEF was trying to bring together the public and the private sectors through the Regionalized Vaccine Manufacturing Collaborative. “What we’ve been doing is thinking through what does this ecosystem approach look like? What are the necessary components to ensure vaccine manufacturing is sustained during both peacetime and then able to surge,” said du Moulin. “We have identified seven pillars which include business models, market shaping, public-private financing, manufacturing, innovation, tech transfer, workforce supply chain and last but not least, regulatory harmonisation.” In preparation for the next pandemic, says Hotez: “We need to broaden the ecosystem, broaden the tent and not demonise the pharma companies either. They do a lot of good. They provide a lot of innovation and a lot of important vaccines for the GAVI Alliance. “Remember, COVID-19 is the third major coronavirus epidemic pandemic of the century. We had SARS in 2002, MERS in 2012, and now COVID-19. So the fourth one’s coming. It’s going to happen before the end of this decade and we still haven’t prepared for that.” Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.