Fourth Meeting of the Multilateral Leaders Task Force on Scaling COVID-19 Tools
The heads of the International Monetary Fund, World Bank Group, World Health Organization and World Trade Organization met with the CEOs of leading vaccine manufacturing companies to discuss strategies to improve access to COVID-19 vaccines, especially in low- and lower-middle-income countries and in Africa. The Task Force expressed concerns that without urgent steps, the world is unlikely to achieve the end-2021 target of vaccinating at least 40% of the population in all countries—a critical milestone to end the pandemic and for global economic recovery.
The Task Force members noted that, despite adequate total global vaccine production in the aggregate, the doses are not reaching low- and lower-middle-income countries in sufficient amounts, resulting in a crisis of vaccine inequity. Therefore, the Task Force encouraged countries that have contracted high amounts of vaccine doses and vaccine manufacturers to come together in good faith to urgently accelerate COVID-19 vaccine supplies to COVAX and AVAT, two multilateral mechanisms crucial for equitable distribution of vaccines.
Task Force members welcomed the willingness of the CEOs to work collectively with them to end vaccine inequity and their readiness to form a technical working group with the Task Force to exchange and coordinate information on vaccine production and deliveries.
The Task Force stressed that if the 40% coverage threshold is to be reached in all countries by the end of 2021, the following actions need to be taken immediately by governments and vaccine manufacturers:
Release doses to low- and lower-middle-income countries: Task Force members note that countries with high vaccination rates have collectively pre-purchased over two billion doses over what is required to vaccinate their populations fully. Therefore, the Task Force calls again on those countries to urgently: i) swap their near-term delivery schedules with COVAX and AVAT, ii) fulfil their dose donation pledges with unearmarked upfront deliveries to COVAX, and iii) release vaccine companies from options and contracts so those doses can be delivered to people in low- and lower-middle-income countries. In addition, vaccine manufacturers should prioritize and fulfil their contracts with COVAX and AVAT.
Transparency on supply of vaccines: To ensure that doses reach countries that need them the most, undeveloped and developing countries, the Task Force calls on vaccine manufacturers to share details on month-by-month delivery schedules for all vaccine shipments, especially for COVAX and AVAT. Its remarks emphasized its call for a moratorium on booster doses until the end of 2021, except the immune-compromised, to help optimize supply in low-income countries.
Eliminate export restrictions, prohibitions: The Task Force calls on all countries to urgently address export restrictions, high tariffs and customs bottlenecks on COVID-19 vaccines and the raw materials and supplies required for the production and timely distribution of vaccines.
Regulatory streamlining and harmonization: The Task Force calls on all regulatory authorities worldwide to create regulatory consistency and standardization on the approval of vaccines and support the acceptance of the WHO Emergency Use Listing procedure. In parallel, efforts should be made to boost vaccines, diagnostics and treatments globally and expedite equitable delivery of such lifesaving tools to developing countries.
Global partnership to make available 120 million affordable, quality COVID-19 rapid tests for low- and middle-income countries.
A complete access package includes WHO policy guidance on the use of antigen-based rapid diagnostic tests, manufacturer volume guarantees for low and middle-income countries, catalytic funding to assist governments in deploying the tests and an initial US$50 million procurement fund.
WHO is assessing several rapid, point-of-care antigen tests for Emergency Use Listing (EUL)
Agreements between the Bill & Melinda Gates Foundation and test manufacturers Abbott and SD Biosensor make available innovative tests priced at a maximum of US$5 for low- and middle-income countries (LMICs)
The Global Fund commits an initial US$50 million to enable countries to purchase the new tests, with the first orders expected to be placed this week.
Expedited market introduction of these tests in multiple LMICs is supported through the Africa Centres for Disease Control and Prevention (Africa CDC), Unitaid, FIND, CHAI, and their partners.
This is the latest movie from the Access to COVID-19 Tools (ACT) Accelerator to develop, procure and distribute critical new tools to fight the pandemic; new tests are urgently needed to meet the vast unmet needs for testing worldwide.
A set of agreements to make available, for low and middle-income countries, affordable, high-quality COVID-19 antigen rapid tests were today announced by the Access to COVID-19 Tools (ACT) Accelerator. Organizations involved in the milestone agreement include the Africa Centres for Disease Control and Prevention (Africa CDC), the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid, and the World Health Organization (WHO).
As part of this comprehensive, end-to-end effort, the Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with rapid diagnostic test (RDT) producers Abbott and SD Biosensor. These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) – priced at a maximum of US$5 per unit – over six months. These tests provide results in 15–30 minutes rather than hours or days. In addition, they will enable expansion of testing, particularly in countries that do not have extensive laboratory facilities or trained health workers to implement molecular (polymerase chain reaction or PCR) tests.
The tests developed by Abbott and SD Biosensor are highly portable, reliable, and easy to administer, making testing possible in near-person, decentralized healthcare settings. In addition, both companies’ tests are faster and cheaper than laboratory-based tests, enabling countries to increase the pace of testing, tracing and treating people for COVID-19 at the point of care, particularly in areas with under-resourced health systems. Several other Ag RDTs are at various stages of development and assessment.
To scale up the Ag RDTs, the Global Fund today announced that it has made available an initial US$50 million from its COVID-19 Response Mechanism to enable countries to purchase at least 10 million of the new rapid tests for LMICs at the guaranteed price. The first orders are expected to be placed this week through the Global Fund’s pooled procurement mechanism.
FIND and WHO are working together to accelerate appropriate use by supporting implementation research to optimize Ag RDT use in multiple LMICs, in line with WHO guidance. This includes providing catalytic volumes of tests to understand how Ag RDTs can best fit into health systems.
Unitaid and Africa CDC will combine resources to initiate the roll-out of these tests in up to 20 countries in Africa starting in October 2020. This multi-million-dollar intervention, currently undergoing final sign-off by their Boards, is designed to engage multiple partners active in the COVID-19 response in these countries, such as CHAI, African Society for Laboratory Medicine (ASLM) and local organizations. In addition, this will bolster efforts by the African Union’s Partnership to Accelerate COVID-19 Testing (PACT) initiative, launched in August 2020, to mobilize experts, community workers, supplies and other resources to minimize the impact of the pandemic on the African continent by testing, tracing, and treating COVID-19 cases promptly.
Testing is a critical cornerstone of the COVID-19 response, enabling countries to trace and contain the virus now and prepare for the roll-out of vaccines once available. Effective testing strategies rely on a portfolio of test types used in different settings and situations. While molecular tests started to be rolled out within a month of the virus being sequenced, they are mainly laboratory-based, relying on infrastructure and trained personnel to conduct them. Rapid tests to detect the presence of the virus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19.
WHO guidance published on 11 September 2020 highlights the value of these tests in areas where community transmission is widespread and where nucleic acid amplification-based diagnostic (NAAT) testing is either unavailable or where test results are significantly delayed. As well as supporting test-trace-isolate strategies, the tests can help identify or confirm new outbreaks, support outbreak investigations through screening, monitor disease trends; and potentially test asymptomatic contacts.
The ACT-Accelerator Diagnostics Pillar is co-convened by FIND and the Global Fund, working closely with WHO and over 30 global health expert partners to accelerate innovation and overcome the technical, financial, and political obstacles to achieving equitable access to adequate and timely testing. Such unprecedented international collaboration has enabled the development and deployment of the first WHO EUL-approved Ag RDT within eight months of the first identification of the virus. In comparison, it took nearly five years to develop the first RDT for HIV. Several more antigen RDTs for COVID-19 are currently under WHO EUL review. Overall, the ACT-Accelerator Diagnostic Pillar aims to facilitate 500 million tests to LMICs within 12 months.
These agreements are critical to fulfilling the essential objective of the ACT-Accelerator: to ensure all countries, regardless of income, have fair access to new tests and tools to fight COVID-19. The exceptional speed with which the Ag RDT access package has been created demonstrates the breadth of the ACT-Accelerator initiative’s impact. This and future achievements in testing will complement similar milestones anticipated to emerge from the Vaccines and Therapeutics Pillars.
Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, said: “High-quality rapid tests show us where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission. The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”
Mark Suzman, Chief Executive Officer of the Gates Foundation, said: “TestingTesting is an essential tool in the fight against COVID-19. We are delighted to join a partnership that will help ensure that the latest, high-quality diagnostics do not just go to the highest bidder but will be available at an affordable price to the world’s lower-income countries. In addition, all of the actions announced point today to the growing success of the ACT-Accelerator in catalyzing global cooperation for an appropriate and effective response to this global crisis.”
Dr Iain Barton, Chief Executive Officer of CHAI, said: “These agreements will help ensure that millions of people in low- and middle-income countries have access to high-quality rapid testing in villages and towns as well as cities. This has the potential to revolutionize the government’s ability to respond to the pandemic, enabling quick diagnosis and response to contain localized virus outbreaks before they spread.”
Andrea F. Wainer, Executive Vice President of Abbott’s rapid and molecular diagnostics businesses, said: “Abbott is pleased to bring our Panbio COVID-19 rapid antigen test and Sympheos digital solution to people and health authorities in low- and middle-income countries through this innovative partnership. We have long been committed to making sure our life-changing technologies are affordable and accessible, and for decades have been supporting many of these countries with our rapid tests for malaria, HIV, hepatitis, and other deadly infectious diseases.”
Hyo-Keun Lee, Chief Executive Officer of SD Biosensor, said: “We, SD Biosensor, are pleased to supply our STANDARD Q COVID-19 rapid antigen tests for people who need fast and accurate COVID-19 diagnosis. Through this partnership, we will keep striving to do our best to provide the best quality of COVID-19 antigen rapid kits for fighting COVID-19.”
Dr John Nkengasong, Director of the Africa CDC, said: “Antigen tests are an important complement to PCR testing and crucial to expanding testing capacity throughout Africa. The beauty of antigen testing is that it is fast and gives quick results. It will allow healthcare workers to quickly isolate cases and treat them while tracing their contacts to cut the transmission chain.”
Dr Philippe Duneton, Unitaid’s Executive Director a.i., said: “AccessAccess to these point-of-care rapid tests with being a game-changer in the fight against COVID-19. We are working to support countries to rapidly deploy and use these new tests in the best possible way. Today’s news shows what the ACT-A partners working together can deliver in our efforts against the COVID-19 pandemic.”
Dr Carolyn Gomes, Special Advisor for the Board, ProActividad, Jamaica, and Alternate Board Member (Developing Country NGOs), The Global Fund “Ensuring equitable access to rapid diagnostic tests is essential for controlling COVID-19 in all countries and to opening up economies across the world. Ensuring an affordable price is a major step forward. Tests that can be used at the point of care by front-line workers will greatly facilitate community access to testing. To ensure equity in access for those who need it most, there will need to be much greater support of the ACT-Accelerator and the Diagnostics Pillar in particular. Much more money is needed to meet the needs of the most vulnerable.”
Peter Sands, Executive Director of the Global Fund, said: “This is the ACT-Accelerator in action. It is proof that we can develop and deploy a vital new tool to help contain and fight the pandemic by working together at a massive global scale. This is not just a new test – it’s the money and the deployment plan to get it to where it’s needed, fast. This is the power of global collaboration.”
Dr Catharina Boehme, Chief Executive Officer of FIND, said: “With this Ag RDT package, the ACT-Accelerator partners have secured much-needed tools for LMICs to increase COVID-19 testing dramatically. With the financial support of several countries, we have made great progress. Still, to ensure we reach all those who need testing and bring the prices down, we urgently need substantial funding from public, philanthropic, and multilateral sources.”
About the ACT-Accelerator
The Access to COVID-19 Tools (ACT) Accelerator is a new, ground-breaking global collaboration to accelerate 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 2020 and launched by WHO, the European Commission, France and the Bill & Melinda Gates Foundation in April 2020. The ACT-Accelerator is not a decision-making body or a new organization but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table to end the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines. Thereby it is protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations tackling the world’s most challenging health challenges, and who, by working together, can 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.
The Diagnostics Pillar of the ACT-Accelerator is focused on ensuring that everyone who needs a test can get one. Workstreams span research and development, market readiness, procurement, and country preparedness. Achievements to date include laboratory training in partnership with Africa CDC in early February and a suite of online courses deployed within weeks. In addition, nearly 20 million tests have been procured with the Diagnostics Consortium, ensuring diagnostic access for LMICs and readiness for test-and-treat implementation in these countries. Independent antibody tests are also being conducted, as high-quality antibody tests are essential to understanding population immunity for future vaccine roll-out.