Senegal nears completion of 'bespoke' vaccine manufacturing facility

The European Investment Bank announced last week that it would provide a €75 million (over $80 million) loan to the Institut Pasteur de Dakar, or IPD, in Senegal. With the injection of funding, the institute plans to fast track operationalization of one of its new vaccine manufacturing facilities. This new manufacturing facility is one of a series of vaccine manufacturing projects launched across Africa and aimed at enhancing health security on the continent by lessening dependence on companies abroad to supply vaccines. These projects came to fruition during the pandemic, as African nations experienced widespread inequitable access to COVID-19 vaccines. “It is essential to create decentralised vaccine manufacturing capacity to address this imbalance and ultimately build a safer and healthier world,” wrote Dr. Amadou Alpha Sall, director of IPD, in a press release. The Senegal facility expects to produce a range of vaccines, using pouches in addition to vials, and a modular approach — meaning the facility’s labs are built inside shipping containers to give the institute more flexibility. It aims to create a “whole new, broader platform for making vaccines and biologics” as opposed to creating a facility targeting a specific disease, Dr. Joe Fitchett, senior adviser for biotechnology at the institute, told Devex. “It certainly will be one of the largest [vaccine production] facilities in Africa, and it's probably the largest dedicated to emerging epidemics,” he said. A modular facility IPD has a three-pronged approach to vaccine production, under a single vaccine manufacturing campus. EIB’s loan will go towards a new facility, which is named the Manufacturing in Africa for Disease Immunisation and Building Autonomy, or MADIBA. This facility expects to produce up to 300 million doses of vaccines a year when operating at full capacity. The facility is in the town of Diamniadio, located between Dakar and the international airport. It aims to produce COVID-19 vaccines, as well as essential childhood vaccines for diseases such as measles, rubella, and polio. It also intends to produce vaccines for “Disease X” — a future unknown, or reemerging, pathogen with outbreak potential. Currently, the vaccine development will happen outside of the institute. But according to the Coalition for Epidemic Preparedness Innovations, 25 viral families are known to infect humans and “over 1.6 million yet-to-be-discovered viral species from these viral families are estimated to exist in mammal and bird hosts.” While it’s not able to prepare vaccines in anticipation of spillover events from all of these threats, in order to prepare for “Disease X,” it's possible to create a “a library of prototype vaccines and other biological interventions against representative pathogens from each of these 25 viral families.” CEPI aims to create vaccines against emerging diseases in only 100 days. The new facility will also produce protein subunit and adenoviral vector vaccines as well as a fill and finish capacity — the end of the vaccine manufacturing process— for a range of vaccines and biologics. “It certainly will be one of the largest [vaccine production] facilities in Africa, and it's probably the largest dedicated to emerging epidemics.” --— Dr. Joe Fitchett, senior adviser for biotechnology, Institut Pasteur de Dakar The facility already houses pharmaceutical modules, which are labs that are made within converted shipping containers. A company in Sweden produced these modules, simultaneously, while the rest of the facility was built, Fitchett said. The first set, which has the capacity to perform the fill and finish process, arrived in Senegal in April. Building labs in shipping containers gives the facility flexibility. As the science around vaccine production evolves, the institute can simply change the module — take out the shipping container lab, re-kit it, and replace it — rather than rebuilding the entire building. It allows the institute to build a “very, very bespoke facility,” he said. With the near completion of the building and the arrival of the first set of shipping container labs, aka modules, the facility expects to start producing vaccine doses by the end of the year through fill and finish, Fitchett said, although the institute has not yet announced which type of vaccine it will start producing this year. Next year it expects to produce vaccines through the full process, from start to finish. EIB funding facilitates the completion of the construction of the building — which started last July — and supports the purchase of the shipping container labs that can produce the drug substance for vaccines, as well as other drug products, he said. There was a need for a “step change” in funding, which was achieved through the EIB loan, support from the Senegalese government and other partners. The institute is a foundation with profits reinvested in areas including research and surveillance, often for diseases the global community neglects. Because of this, funding on the scale of the EIB loan would have “required many, many years of saving to be able to do it without this support,” Fitchett said, adding that it means the facility can now spring into operation more quickly. The total funding needed for this new facility is $222 million, including working capital — and the institute expects to announce additional financiers “in due course,” he said. The International Finance Corporation has committed to help the institute raise funds for the project. This facility will produce vaccines in pouches as well as in traditional vials. This allows for a longer lifespan while refrigerated of up to six days, rather than six hours — with between about 50 and 200 doses in a pouch. This technology was developed in the United States and brought to the institute by CEPI. During a major epidemic, when health workers need to immunize large numbers of people quickly, pouches reduce dependency on vials — and are less heavy, Fitchett said. Beyond this facility, IPD and BioNTech, which produces a messenger RNA COVID-19 vaccine, are building an mRNA manufacturing facility with funding from BioNTech. This facility is still in the advanced planning stages. It will also use modules shipped in from Germany. The institute also has a long history of fully producing yellow fever vaccine for 80 years. This uses egg-based production, where the vaccine is made inside of sterile eggs, which are imported on a weekly basis from Germany. It’s a specific technique that works for a small number of essential vaccines such as influenza, but it's complicated and expensive, Fitchett said. If you build it, will they come? The sustainability of new vaccine manufacturing plans across the African continent has been called into question in recent months, as South Africa’s Aspen Pharmacare raised the alarm that the international procurement entities, COVAX and Gavi, the Vaccine Alliance, are not purchasing COVID-19 vaccines, and so the company might be forced to shut down production. This was the first company on the continent to produce COVID-19 vaccines. While Aspen is producing a very specific COVID-19 vaccine — the Johnson & Johnson vaccine — through the fill and finish process, in Senegal, IPD has a broader approach that includes a variety of vaccines, which helps to ensure long-term sustainability of its vaccine manufacturing ambitions, Fitchett said. “That's what makes this facility a bit different to some of the others — because there are many facilities now being built in Africa. That breadth is one of the differentiating factors and the other, of course, is how fast we've moved and how close we are to completing our build,” he said. He added that it's also best to evaluate the effectiveness of vaccines in the midst of big outbreaks, which is why it's necessary to have multiple vaccine candidates ready for when that happens. Surveillance that feeds into vaccine development West Africa is no stranger to outbreaks. An Ebola outbreak and a case of Marburg, a similar hemorrhagic fever, hit Guinea last year. Because of the high risk of disease spillover from animals to humans in the region, it's important to have an active surveillance network, coupled with development facilities where health authorities can send samples to generate candidates for diagnostics, treatments, and vaccines, Fitchett said. “That really hasn't happened enough in the region over the past years, but that's what's changing,” he said. The institute works with the government of Senegal across 23 sentinel surveillance sites covering each region of the country, and is working with the Africa Centres for Disease Control and Prevention and the West African Health Organization to connect laboratory and surveillance systems across West Africa.