15 Jul 2021
15 July 2021, Oslo, Norway – The Coalition for Epidemic Preparedness Innovations (CEPI) and COVAX partners are launching an innovative ‘marketplace’ to accelerate the global production of COVID-19 vaccine doses for COVAX by matching suppliers of critical inputs with vaccine manufacturers who urgently need them to produce vaccines for fair and equitable distribution through COVAX. This initiative is a key deliverable of the COVAX Manufacturing Task Force, which is co-led by COVAX and industry partners .
In the past year unprecedented efforts by vaccine manufacturers and suppliers of vaccine components have aimed to triple previous annual vaccine output, scaling up to produce an estimated 11 billion doses of COVID-19 vaccine by the end of 2021 [2,3]. As a result of this historic scaling up, bottlenecks are affecting the global supply chain leading to acute shortages of vital supplies which are preventing COVID-19 vaccine manufacturers from operating at full capacity. This is delaying vaccine production and contributing to inequity.
The new COVAX Marketplace announced today is designed to address short-term bottlenecks by facilitating access to supplies needed to produce COVID-19 vaccines intended for distribution through COVAX. It will provide a secure platform for vaccine manufacturers and suppliers of critical inputs to confidentially indicate their needs or available supplies to CEPI, in its role as facilitator. CEPI will identify matching offers and requests and connect potential matches, prioritising based on objective criteria including whether the manufacturer has a COVAX advance purchase agreement and WHO EUL in place, as well as dose volumes and delivery timings. Future versions of the Marketplace may include supplies required to manufacture other lifesaving therapies and vaccines which are also being affected by current global supply shortages.
The Marketplace is expected to improve the free flow of critical COVID-19 vaccine supplies by:
Providing suppliers with a platform to allocate and reallocate unused materials.
Mobilizing idle stock from vaccines and candidates that fail prior to gaining regulatory approval – as well as from those that might scale down their production in the future.
Mobilizing potential surplus stock from manufacturers with non-vaccine activities.
Vaccine manufacturing processes are highly complex and expanding manufacturing capacity requires managing intricate cross-border supply chains frequently involving more than 100 components. Participants will be able to offer and request any materials required for vaccine production through the COVAX Marketplace, but it will initially focus on six categories of supplies which have been identified as critical: bioreactor bags, single use assemblies, cell culture media, filters, lipids, vials and stoppers.
Towards a scalable Marketplace platform
The COVAX Marketplace launching today is an initial version which aims to respond quickly to immediate market needs and bottlenecks. It will launch with approximately 10 – 15 participants, comprising COVAX vaccine manufacturers and suppliers of the key materials which have been identified as being most urgently needed. In parallel, in consultation with stakeholders CEPI is urgently exploring extending the Marketplace to include additional participants such as vaccine manufacturers with unused inputs – including those with failed products – Contract Development and Manufacturing Organizations (CDMOs), and pharmaceutical companies not currently involved in COVID-19 vaccine production. This would provide a platform to resolve supply bottlenecks which could extend beyond COVID-19 vaccines to other lifesaving therapies and vaccines which are being impacted by the current supply situation.
Dr Richard Hatchett, CEPI CEO, said: “Vaccine manufacturers have described the ways in which shortages of critical supplies have limited the speed and scale at which vaccines can be produced, which means many vaccine production lines haven’t been operating at full capacity. Optimizing the use of scarce resources that may otherwise be sitting idle – by matching buyers and sellers around the globe – could contribute to improving the global supply of vaccines through COVAX. The pandemic has led to extraordinary innovation in vaccine development and production, and the COVAX Marketplace is an example of how we must continue to look beyond business as usual to find pragmatic solutions to fixable problems – such as supply chain bottlenecks – so that we can urgently unlock more COVID-19 vaccine doses for COVAX.”
Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers (IFPMA), said: “Today, over 3 billion doses of effective and safe vaccines have been made and administered. But to vaccinate the world’s adult population by the end of the year, we must achieve the estimated production of 11 billion doses of COVID-19 vaccines. To do this, it is essential to optimize production, as well urgently increase dose sharing and remove trade barriers. A delay in the delivery of a bioreactor plastic bag can halt a whole production line and delay a batch of thousands of litres for weeks, if not months. To alert the international community to the challenges associated with this historic scaling up of vaccine production, in March 2021 we joined the Chatham House Summit on COVID-19 Vaccine Manufacturing Supply Chain. One of the recommendations, strongly endorsed by industrialised, developing world vaccine manufacturers and biotech companies, was to find a practical solution to removing the inevitable bottlenecks for raw materials and components. We are delighted to have been able to contribute to the creation of this platform to facilitate matching supplies with buyers, thereby ensuring manufacturing supplies for COVID-19 vaccines. Speed is of the essence to achieve vaccine equity. This marketplace will hopefully make an important contribution towards the global endeavour of achieving the 11 billion doses target this year.”
Sai Prasad, President of Developing Country Vaccine Manufacturers’ Network, said: “Within a year and a half into this pandemic we now have several safe and effective vaccines with demonstrated evidence in real world settings. Industry from both developing and developed world have shown leadership in product development and large-scale manufacturing, resulting in more than 3 billion doses manufactured. While this is a successful outcome for most infectious diseases, it is clearly not enough to address the global public health crisis caused by this pandemic. We now need to scale up at a rapid speed to reach a production capacity of more than 10 billion doses annually. With the complexities involved with vaccine manufacturing requiring specialized human resources, facilities, raw materials, consumables etc, we need to enable the entire supply and distribution chain to rise up to this challenge. The COVAX Marketplace will enable partnerships focused on removing bottlenecks, increasing capacities and attaining our goal of vaccinating the world.”
Kevin D. Ott, Executive Director of Bio-Process Systems Alliance (BPSA), said: “BPSA’s 64 Members applaud CEPI and its partners for launching the COVAX Marketplace. It’s been said that ‘rocky roads lead to beautiful places’: the Marketplace is an exceptional and timely effort to match marketplace needs with available supplies, helping to smooth that road to global immunization with the tools and technologies needed to make the world safe again.”
 The COVAX Manufacturing Taskforce is spearheaded by the co-leads of COVAX – CEPI, Gavi, UNICEF and WHO – working in partnership with the Bill & Melinda Gates Foundation, and organizations representing vaccine manufacturers: International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Developing Countries Vaccine Manufacturers’ Network (DCVMN), and Biotechnology Innovation Organization (BIO).
 Towards Vaccinating the World: Landscape of current COVID-19 supply chain and manufacturing capacity, potential challenges, initial responses, and possible ‘solution space’ – a discussion paper, 9 March 2021
COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by CEPI, Gavi, the Vaccine Alliance Gavi) and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.
About the COVAX Manufacturing Task Force
The COVAX Manufacturing Task Force has been established to identify and resolve issues impeding equitable access to vaccines through COVAX. The Task Force will leverage the capabilities of the global vaccine community—from vaccine R&D stakeholders through to those working in the clinical development, manufacturing, and regulatory sectors—to address short-term, medium-term, and long-term COVID-19 vaccine manufacturing challenges and bottlenecks.
The Task Force aims to urgently address shortages of raw materials and single-use materials (potentially ramping-up supply capacity) and expedite cross-border transit of these materials, vaccine components, and finished products. It will also seek to match up manufacturers who are experiencing specific shortages with those who might have the necessary supplies. The longer-term aim will be to help strengthen regional health security for the future.
The work of the Task Force is supported by the ACT Accelerator Vaccine Manufacturing Working Group, co-led by South Africa and Germany, which is focused on the actions needed to enhance supply of vaccines through COVAX.
CEPI’s role in COVAX
CEPI leads the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of multiple safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work CEPI has secured first right of refusal to doses for the COVAX Facility to a number of candidates, and the COVAX Facility now has agreements in place to access over 2.7 billion doses of vaccines from the R&D portfolio. CEPI has also made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.
Gavi’s role in COVAX
Gavi leads on procurement and delivery at scale for COVAX: designing and managing the COVAX Facility and the Gavi COVAX AMC and working with its traditional Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. As part of this role, Gavi hosts the Office of the COVAX Facility to coordinate the operation and governance of the mechanism as a whole, holds financial and legal relationships with 193 Facility participants, and manages the COVAX Facility deals portfolio: negotiating advance purchase agreements with manufacturers of promising vaccine candidates to secure doses on behalf of all COVAX Facility participants. Gavi also coordinates design, operationalisation and fundraising for the Gavi COVAX AMC, the mechanism that provides access to donor-funded doses of vaccine to 92 lower-income economies. As part of this work, Gavi provides funding and oversight for UNICEF procurement and delivery of vaccines to all AMC participants – operationalising the advance purchase agreements between Gavi and manufacturers – as well as support for partners’ and governments work on readiness and delivery. This includes tailored support to governments, UNICEF, WHO and other partners for cold chain equipment, technical assistance, syringes, vehicles, and other aspects of the vastly complex logistical operation for delivery. Gavi also co-designed, raises funds for and supports the operationalisation of the AMC’s no fault compensation mechanism as well as the COVAX Humanitarian Buffer.
WHO’s role in COVAX
WHO has multiple roles within COVAX: It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL) / prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. WHO leads, together with UNICEF, the Country Readiness and Delivery workstream, which provides support to countries as they prepare to receive and administer vaccines. Along with Gavi and numerous other partners working at the global, regional, and country-level, the CRD workstream provides tools, guidance, monitoring, and on the ground technical assistance for the planning and roll-out of the vaccines. Along with COVAX partners, WHO has developed a no-fault compensation scheme as part of the time-limited indemnification and liability commitments
UNICEF’s role in COVAX
UNICEF is leveraging its experience as the largest single vaccine buyer in the world and working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as freight, logistics and storage. UNICEF already procures more than 2 billion doses of vaccines annually for routine immunisation and outbreak response on behalf of nearly 100 countries. In collaboration with the PAHO Revolving Fund, UNICEF is leading efforts to procure and supply doses of COVID-19 vaccines for COVAX. In addition, UNICEF, Gavi and WHO are working with governments around the clock to ensure that countries are ready to receive the vaccines, with appropriate cold chain equipment in place and health workers trained to dispense them. UNICEF is also playing a lead role in efforts to foster trust in vaccines, delivering vaccine confidence communications and tracking and addressing misinformation around the world.
The Access to COVID-19 Tools ACT-Accelerator, is a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.
The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.
The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale, and access. These programmes leverage the rapid response platforms previously developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at endpandemics.cepi.net.
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