MANILA — An international initiative that aims to deliver much-needed COVID-19 test kits to low- and middle-income countries is severely underfunded, and faces challenges negotiating accessibility and affordability.
The Access to COVID-19 Tools Accelerator, launched in April, aims to ensure equity in the distribution of COVID-19 diagnostics, vaccines, and treatment to all countries. The initiative was launched with much fanfare, with some of the most high-profile leaders voicing their support. But global demand for the products and nationalistic mentality in some countries are challenging its ambitions.
Diagnostics, one of the major pillars of the initiative and an important tool in reducing virus transmission has received commitments of roughly $250 million of the $2 billion needed in the immediate term. The money would ensure the delivery of 500 million test kits to LMICs, spur innovation, and help strengthen countries’ diagnostic capacities, said Dr. Catharina Boehme, CEO of FIND, a co-convenor of the ACT Accelerator’s diagnostics pillar.
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She said the importance of COVID-19 testing to contain the spread of the disease and allow economies to reopen has not translated to funding.
“There's clearly sort of a lack of solidarity. And the notion that nobody's safe until everybody is safe, clearly sort of hasn't translated either into funding commitments,” she said.
Development leaders have already expressed concerns about the impact of COVID-19 on donor aid budgets. With high-income countries’ economies taking a hit while managing the crisis at home, it is expected that development aid budgets will stall, or even decrease in real terms due to reduced revenue. But the financial crunch is already being felt in the diagnostics space.
“With GDPs decreasing dramatically, most [donor] countries indicate to us, but also our partners, that they're running into huge financial constraints to support the COVID-19 response,” Boehme said.
The diagnostics pillar is hoping support will come from other sectors, and is in discussion with some foundations. Some major foundations have yet to contribute funding to the diagnostics pillar, said FIND’s chief executive.
“When we look at the testing rates, for example, in Africa, it's only about 0.1% to 1% of the testing that's being done in high-income countries.”
— Dr. Catharina Boehme, CEO, FINDThe Bill & Melinda Gates Foundation has to date committed over $350 million to the global COVID-19 response. It’s unclear what that entails, but in its grants database, Devex found over 20 awarded grants from March 2020 focused on developing diagnostics tools, harnessing the power of data to inform better diagnosis, and to increase in-country capacity testing — but not to the diagnostics pillar. The Gates Foundation did not reply to Devex’s emails on the subject.
The Chan Zuckerberg Initiative has given funding for diagnostic machine purchase and support in the San Francisco Bay Area, where the foundation has its office, according to information on its COVID-19 response page. It also committed $25 million to the COVID-19 Therapeutics Accelerator, or CTA. But no funding to the ACT Accelerator, which is a separate initiative.
The Wellcome Trust has also not made an investment to the diagnostics pillar, but it is a co-convenor of the ACT Accelerator’s therapeutics pillar, and a founding donor of CTA. Wellcome has contributed $50 million to CTA but has not directly invested in the ACT Accelerator’s therapeutics pillar. A Wellcome spokesperson said that the CTA investment would benefit ACT by furthering research into treatments that inform the accelerator’s work.
The Rockefeller Foundation has been active in helping expand COVID-19 testing in the U.S. The foundation previously provided seed funding for pooled procurement of diagnostic tests in parts of Africa and Asia, and its board has approved additional funding for its work in LMICs, said Jonathan Quick, the foundation’s managing director for pandemic response, preparedness, and prevention.
But at the moment, no funding has been provided to the diagnostics pillar, with the foundation’s global investments still being finalized, said Manisha Bhinge, who leads the foundation’s global work with FIND.
Funding is critical. The biggest budget line in the $2 billion short-term need is for the procurement of test kits for LMICs. Many of these countries don’t have the financial capacity to procure large volumes of test kits compared to many high-income countries.
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The COVID-19 Supply Chain Task Force was set up in early April to help get the necessary supplies to LMICs. The task force was set up to leverage different global organizations’ procurement capabilities and expertise, including in the purchase and delivery of COVID-19 diagnostic supplies.
Because of the limited testing kits available, the World Health Organization has developed an allocation model to ensure limited supplies are allocated equitably. The allocation was calculated based on a set of criteria, including an at-risk population, a country’s health system vulnerability and access to market, and testing capacity. In future iterations of the model, the epidemiological context in countries will be factored in.
Some of the biggest diagnostic companies, whose products have shown early evidence of effectiveness in detecting the virus in patients and have a significant presence in many LMICs, have agreed to work with the consortium. Basically, they tell the consortium how many of their test kits they can produce and make available to LMICs. The total volume committed is then allocated to countries based on the agreed-upon criteria.
Approximately 14 million of the roughly 16 million secured volumes of test kits have since been shipped out to countries through this mechanism, but Boehme admitted it was not enough — both the funding, and the committed test supplies.
The pillar has negotiated with a number of key companies to get access to test kit supplies, including Thermo Fisher, Cepheid, Roche, and Abbott.
FIND has declined to identify all companies involved. But of the companies’ total supplies, only an estimated 20% have been made available for LMICs.
While Boehme agreed that the available number of test kits for LMICs is small, she said it could’ve been lower had these companies not gone to the negotiating table.
Even some small, high-income countries are struggling to access high-quality test kits, Boehme said, leading them to ask for space in the allocation model.
“Right now you're at the mercy of the whims of companies to pick which countries, for which price, at what time, at what level of supply that they will fulfill their orders.”
— Sharonann Lynch, HIV and TB policy adviser, MSF's Access CampaignMedecins Sans Frontieres, which actively campaigns for access and cheaper medicines for LMICs, raised concerns on the unequal distribution of limited testing supplies. Last week, it accused Cepheid of “prioritizing high-income countries at the expense of people in low resource settings,” and of “profiteering” from the pandemic by charging nearly $20 per test for its Xpert Xpress SARS-COV2 test cartridges.
Cepheid could charge significantly less and still profit at $5 per test — based on MSF’s analysis of the cost of manufacturing Cepheid’s tests for tuberculosis and the volumes in demand for COVID-19 testing — said Sharonann Lynch, HIV and TB policy adviser for MSF's Access Campaign. Lynch also added that the company has received funding from the U.S. Biomedical Advanced Research and Development Authority worth $3.7 million.
“They need to be making every effort to ensure that their products are affordable,” she said, as the diagnostics consortium enters the next round of commitment negotiations with diagnostic companies.
The machines needed to run the Xpert Xpress SARS-COV2 test are already being used in many countries to diagnose diseases like TB.
“One of the reasons that we're talking about diagnostics [is because of the] obvious need for them, but also this portends the story in terms of how vaccines and therapeutics will go, unless we figure it out, unless we get our global health in order. And you know, right now you're at the mercy of the whims of companies to pick which countries, for which price, at what time, at what level of supply that they will fulfill their orders,” Lynch told Devex.
In response, Cepheid said that the independent calculations by MSF on the cost of its test cartridges are incorrect. The company said that the $5 price tag is less than the cost, and that the cost to produce the COVID-19 tests is higher than the cost to produce its TB tests. The company has been in dialogue with MSF and the Treatment Action Group about this topic, Darwa Peterson, spokesperson for Cepheid, told Devex via email.
“In June, we also donated 100,000 COVID tests to be distributed to the areas of greatest need by STOP TB. Unfortunately though, no matter how well intended — a campaign to lower the cost of all tests to a single price point of $5 is not realistic when that continues to be below our cost to manufacture,” Peterson wrote.
The best price the diagnostics pillar has been able to negotiate for manual PCR-based tests is $12 to $15. Boehme is hopeful that once easy-to-use, rapid diagnostic kits — similar to pregnancy test kits — have been proven to work and become available, that they would be able to get them at $2 to $3 per test. This type of test is crucial to ramp up testing in countries, as PCR-based diagnostic kits are expensive and cumbersome to use.
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“[The rapid diagnostic kits have] slightly lower sensitivity, so they're slightly less accurate, but they have of course huge advantages in terms of transportability, temperature stability, [and the] feasibility of rolling them out as point of care tests, ie, in communities, in emergency rooms, etc. So that is a big advantage,” she said.
It’s unclear when this kind of test will be available. There are over 100 rapid tests detecting antibodies or antigens commercially available today, and FIND is evaluating over 35 of such tests. FIND has seen some promising results for two antigen-based tests. However, the challenge again, will be supply.
A U.S.-based company developing one of these tests has already communicated to Boehme that it has already committed all of its supplies to the U.S. domestic market. But Boehme is hopeful another company would be able to supply its rapid diagnostic kits to LMICs, once proven effective.
“A lot of the companies get locked in to providing just to their domestic markets. And that remains a very sad fact,” Boehme said.
But the work doesn’t stop there. While making test kits available to LMICs is critical, a lot still needs to happen on building countries’ capacity for testing. A lot of countries continue to struggle with their testing strategies, and in having sufficient personnel to speed up testing.
A lot is being done in that space, with different organizations working with countries on training, developing strategies and guidelines. But Boehme said more needs to be done.
“A lot is happening, but by far not enough, and the testing rates in most low- and middle-income countries still remain very low and remain a fraction, right? So when we look at the testing rates, for example, in Africa, it's only about 0.1% to 1% of the testing that's being done in high-income countries,” she said.
Update Aug. 4, 2020: This article has been updated to clarify Wellcome’s statement about the investment in the diagnostics pillar was from a spokesperson.