Global COVID-19 Vaccine Task Force Lays Out Plans To Scale Up Production and Fill US$18.5 Billion Gap Pandemics & Emergencies 12/05/2021 • Madeleine Hoecklin & Elaine Ruth Fletcher 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) The sixth meeting of the ACT-Accelerator Facilitation Council on Wesnesday. In a rush to jumpstart more global vaccine manufacturing capacity, the global COVAX vaccine facility is now stepping into the fray. A new COVAX Supply Chain and Manufacturing Task Force has laid out a three-stage plan to enhance existing vaccine production capacity, as well setting up a new “vaccine manufacturing group” – to further expand production long-term. The plan aims to address immediate manufacturing bottlenecks, expanding existing capacity and workforce capacity limitations as fast as possible, through: Identifying and matching “fill and finish” manufacturers with producers of active ingredient; Accelerating approvals of export permits/customs clearances; Facilitating partnerships for the supply of vital vaccine inputs. “From the COVAX facility, the critical issue that we’re focused on as of today, is how do we get doses today to try to make a difference, and that means stopping these export bans, it means making sure that if there are surplus doses that those get shared, it means trying to accelerate the production of vaccines that are being made and to make sure that every facility that has capability can be used,” said Seth Berkley, CEO of Gavi, the Vaccine Alliance, speaking at the session. According to Berkley’s vision, over the next few months, COVAX will be focused on ensuring there aren’t shortages in products or delays at existing manufacturing facilities. Over the medium-term, through end- 2022, a manufacturing workforce will be developed to maximize even more production using existing systems. The long-term goals of COVAX, meanwhile, include expanding production capacity in low- and middle-income countries, and particularly in Africa, through efforts such as a new mRNA vaccine technology hub, led by WHO. The Task Force’s three-part preliminary plan to enhance and expand vaccine production capacity. As an opening shot, a US-based foundation said it would donate some US$213 million to catalyze the expansion of manufacturing capacity in South Africa, announced Dr Patrick Soon Shiong, CEO of ImmunityBio and NantHealth, and chairman of the US-based Chan Soon-Shiong Family Foundation. The Foundation will provide seed funding to South African biotech partners “so that the capacity, and most importantly second generation vaccinology, second generation cell therapy, and signature delivery systems could be enabled,” said Shiong, a South African native, now living in the United States. “I’ve been interacting directly with my fellow South Africans for the last year and I am more and more convinced that not only do we have the science, we have the human capital, and the capacity and the desire. So South Africa could catalyze capacity building, and self-sufficiency, and most importantly the innovation for Africa and for vaccines,” said Shiong, of the partnership. Dr Patrick Soon Shiong, CEO of ImmunityBio and NantHealth, and chairman of the US-based Chan Soon-Shiong Family Foundation. He was speaking at a meeting of the ACT-Accelerator’s Facilitation Council, which provides WHO member state oversight to the global COVAX vaccine facility, and its umbrella ACT-A initiative, dedicated to expanding equitable access to tests and medicines, as well as vaccines. Addressing ‘Shocking Global Disparity’ While the COVAX facility has delivered 60 million doses to 122 countries, “the shocking global disparity in access to vaccines and other COVID-19 tools remains one of the biggest risks to ending the pandemic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the beginning of the meeting. Cumulative cases and deaths are double what that at the beginning of 2021, he stressed – and part of that is due to uneven rollout of vaccines. High- and upper-middle-income countries represent 53% of the world’s population, but have received 83% of the world’s vaccines. In contrast, over the first five months of 2021, the African continent has vaccinated under 1% of its population, Dr Tedros said. The same inequalities extend to diagnostics, therapeutics, personal protective equipment (PPE), and oxygen – with one million people in low- and middle-income countries (LMICs) needing over four million cylinders of oxygen per day. The ACT- Accelerator, led by Gavi, the Vaccine Alliance, WHO and CEPI (the Coalition for Epidemics Preparedness) – are struggling to address all of these needs simultaneously. Long-term: mRNA Vaccine Technology Transfer – Training Hub As a longer-term thrust, a new WHO vaccine mRNA manufacturing training facility aims to train and develop more vaccine manufacturing professionals – who could help kickstart new vaccine facilities in LMICs. WHO has already received some 42 expressions of interest from countries, institutions and biotech partners to create the hub – which would train professionals in vaccine manufacturing- who would then help to jump start manufacturing facilities in partner LMICs. The 42 expressions of interest from countries, institutions and biotech partners to create the mRNA vaccine technology transfer hub. The approach has been used successfully in the past to stimulate the creation of capacity in LMICs to manufacture flu vaccines – beginning with the H5N1 pandemic (so-called bird flu) scare of 2005. While some vaccine facilities folded after a few years, once pandemic fears declined, others manufacturers have become sustainable producers of vaccines for seasonal flu and childhood diseases – both for domestic and export consumption, WHO insiders say. “Manufacturing of vaccine needs capacity building, not just in the manufacturing, but also in the regulatory environment, in the clinical research environment, in ethics, in quality assurance, and a number of areas, so that will have to happen side by side,” said Soumya Swaminathan, WHO Chief Scientist. The hub and training center are expected to launch by 2022, according to WHO, Gavi and CEPI officials – urging realism against the calls from LMICs to expand manufacturing capacity even more rapidly. Timeline and vision for the WHO COVID-19 mRNA vaccine technology transfer hub. COVAX Sets Up Manufacturing Task Force Coordination Office In yet another thrust, a COVAX Task Force Coordination Office will also be created to map the vaccine manufacturing ecosystem, including shortages in key vaccine raw ingredients, identifying supply gaps for the Task Force address. For instance, nearly 300 vaccine components and inputs, coming from different parts of the world, are required to manufacture one vaccine dose of a Pfizer mRNA vaccine – and so shortages in just one input can create a bottleneck that halts production. “There is this concept of having a Coordination Office where the data is collected, where the supply baseline is being done, and that really is to make sure that we’re all operating from the same point, and share that information as we work with all of those groups including new groups that will come in that have a role to play here,” said Berkley. “The multiple work streams create a very complex set of interactions and tasks and as we have within COVAX where we coordinate across the work stream, we are also going to create a coordinating office that we’re in the process of setting up,” said Dr Richard Hatchett, CEO of CEPI. Gavi and CEPI officials announced that they expect to have the coordination office “fully up and running very shortly,” said Hatchett. WTO Set To Join Manufacturing Task Force Dr Ngozi Okonjo-Iweala, Director General of the World Trade Organization (WTO), announced that WTO would join the COVAX Supply Chain and Manufacturing Task Force at the Facilitation Council meeting on Wednesday. “I’ve decided that WTO should join the effort that is being made on vaccine manufacturing,” said Okonjo-Iweala. “Through the pandemic, trade and supply chains have helped countries meet skyrocketing demand for medical products, like personal protective equipment.” Dr Ngozi Okonjo-Iweala, Director General of the World Trade Organization. “We must continue this by facilitating the cross border flow of vaccines and vaccine components,” Okonjo-Iweala added. Expanding manufacturing capacity and addressing vaccine inequity is related to the TRIPS waiver proposed to the WTO by South Africa and India. The acceptance of this waiver would “allow for increased and diversified access to technology know-how [for the] manufacturing of vaccines, diagnostics and therapeutics,” said Okonjo-Iweala. “An agreement that allows access to vaccines and to manufacturing capability with some automaticity married with trying to still incentivize research and development is very important,” said Okonjo-Iweala. “I’m convinced that if we work hard…we will be able to come to a conclusion that will be practical and beneficial for low income countries,” she added. COVID-19 Vaccine Manufacturing Working Group – Long Term Horizon Meanwhile, as part of a longer-term initiative – a “COVID-19 Vaccine Manufacturing Working Group”, was announced Wednesday by the ACT Accelerator Initiative. That high-level effort, co-chaired by Germany and South Africa, aims to address more fundamental shortages in raw materials, and opportunities for technology transfer by vaccine manufacturers – to increase the long-term stability of doses to the global vaccine facility, COVAX, and ensure the equitable distribution of vaccines by “It has become clear that worldwide demand exceeds existing vaccine supply by far. We therefore very much welcome the establishment of the new COVAX manufacturing and supply chain task force and the respective high level working group,” said Germany’s delegate. “Germany stands ready to take on responsibility and is glad to announce strong commitment to this new working group by taking on the role as co-chair alongside South Africa,” she added. Increased Funding Required for ACT-Accelerator In order to deliver on the promises of the ACT-Accelerator, US$18.5 billion is needed to fill the financing gap. Some US$6 billion was mobilized in 2020 and an additional US$8.5 billion was mobilized so far in 2021, however, more is needed urgently. “More financing is needed. That’s the only way to really deliver on what we have been talking about today, both [to address] the needs, the hardship and the difficult situations in many countries, and to deliver on full implementation in equitable manners of the technologies,” said John-Arne Røttingen, Chair of the ACT-Accelerator Resource Mobilization Working Group. Numerous member states and WHO officials called for increased financial commitments to the ACT-Accelerator at the meeting on Wednesday. “We have to fully finance the ACT accelerator, as [it is] the only global solution to bring about the fastest possible end to the pandemic,” said Okonjo-Iweala. Image Credits: WHO. 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