Breakthroughs Blog: Diagnostics

How highly will global health be prioritized on the G20 agenda? That is the question leaders must grapple with as the final G20 summit of the Indonesian presidency commences next week. Amid a smorgasbord of geopolitical crises, and as COVID-19 fatigue spreads globally, there is a danger that countries will take their eye off the global health ball at the exact moment we need them to be most dialed in. With live negotiations over new funding mechanisms for pandemic preparedness and the future of existing frameworks, the next few months will decide the future of the global health architecture, meaning that there is now a tremendous opportunity to develop new systems that will support and catalyze product development. Here are three key opportunities for G20 leaders to help significantly advance global health, enhance health equity, and support research and development (R&D):1. Act to ensure equity in the administration of The Pandemic Fund.In June, the World Bank board approved the creation of a financial intermediary response for pandemic prevention, preparedness, and response. The Pandemic Fund has been a centerpiece of the Biden administration's health security agenda, and its core focus is to ensure all countries, particularly low-income countries, have the health systems, resources, and infrastructure required to prevent, detect, and respond to future pandemics. Key investment priorities will be strengthening the health workforce, expanding manufacturing capacity for medical countermeasures, and reinforcing health surveillance systems.While this is a very promising initiative, the fund and its underlying structures have been developed at a blistering pace, creating mistrust and confusion regarding its eventual operations and decision-making processes for countries and civil society alike. This is, therefore, a golden opportunity to channel the lessons we have learned from the ongoing COVID-19 pandemic by committing to equity and collaboration now to bolster confidence in the fund and its future administration.Civil society must be included at all levels of priority setting for investment. While there are two civil society seats with voting rights on the board of The Pandemic Fund, it remains unclear what additional mechanisms will be available for outside organizations to provide their expertise and input on where the investments are made. G20 leaders should ensure that The Pandemic Fund’s technical advisory panel has strong civil society representation, including from low- and middle-income countries (LMICs) and affected communities.To further include equity provisions, G20 leaders should also consider creating greater linkages between other elements of the global health security architecture. This includes ensuring that the Global Health Security Agenda has a seat at the table, as the ongoing Global Health Security Agenda framework is an invaluable platform to advance informal, technical discussions and collaborations between an inclusive and important set of stakeholders. Lastly, G20 leaders should support prioritizing interventions that expand country-level capacity, especially investments that strengthen the R&D capacity of LMICs. The fund is set to issue a call for proposals to countries for the first tranche of funds in December. Responses will likely set precedent for the scope of the fund’s activities. Therefore, it is imperative that development and access to medical countermeasures remain key pillars in the gap the fund is looking to address.2. Further establish an equitable, R&D-focused agenda in the next phase of the Access to COVID-19 Tools – Accelerator (ACT-A).There has been much recent speculation on what will become of ACT-A, as the framework’s mandate was set to expire this September. Talks of sunsetting the platform have proved premature, as it recently unveiled a transitionary plan, which kicked off in October and will continue through March of 2023.As ACT-A prepares to enter a new phase, it is vital to address the ongoing concerns and shortcomings of the platform. A recent evaluation of ACT-A’s performance highlighted that LMICs were insufficiently represented and consulted in ACT-A’s model, resulting in a lack of ownership affecting the delivery of COVID-19 tools in LMICs. The evaluation also found that the agencies working on R&D did not sufficiently coordinate their R&D efforts across the vaccine, therapeutics, and diagnostic workstreams.G20 leaders must push ACT-A stakeholders to build on the progress made since the early days of the initiative and enshrine even greater equity and inclusivity structures in their framework. Increased R&D coordination and leadership are also essential to developing medical countermeasures for future pandemics. The G20 Leaders’ Summit is a great opportunity to outline a roadmap for enhanced R&D coordination between the various ACT-A pillars and highlight what additional structures could be developed to ensure progress across the pipelines for the delivery and uptake of new tools for all product types.3. Reestablish commitment to addressing enduring health threats through R&D.While COVID-19 has dominated global health programming, dialogues, and investment for nearly three years, global leaders must take advantage of next week to recalibrate their efforts and underscore their commitment to advancing other health priorities as well. That means recommitting to the fights against malaria, tuberculosis, and HIV/AIDS, which have suffered losses of progress amid the COVID-19 pandemic and addressing the rising threat of antimicrobial resistance. We expect that many countries will use the summit to underscore their pledges to the Global Fund to Fight AIDS, Tuberculosis, and Malaria, with a few stragglers announcing their contributions for this year’s replenishment. While those commitments are vital, funding institutions will not be enough, and additional investment in R&D is needed, particularly in the local production of medicines, vaccines, and diagnostics. G20 countries should also invest in essential public health function gaps; support the capacities of national and regional public health institutes in sub-Saharan Africa (including in field epidemiology, disease detection, laboratory diagnosis, and optimization of the health workforce skill mix); and convene all stakeholders to jointly define targets to accelerate the regional production of vaccines, therapeutics, and diagnostics. These steps will be part of a difficult but long overdue pivot back to health areas that have begun to backslide due to the pandemic. For the last couple of years, leaders have focused disproportionately on COVID-19 to the detriment of several key health areas. We cannot afford to ignore these persistent and reinvigorated crises any longer. Next week will be a chance to recommit to a comprehensive approach to global health that centers both R&D and equity, but G20 leaders need to step up to the plate to advance that vision.

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or is just a figment of our imagination. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.A University of Oxford research team published promising results for a new malaria vaccine, R21. The trial, conducted among 409 children in Burkina Faso, found that an initial three doses followed by a booster after one year showed up to 80 percent efficacy in preventing malaria. The developers say the vaccine can be produced for just a few dollars and that they expect the vaccine to be rolled out next year through a manufacturing deal for more than 100 million doses a year with the Serum Institute of India. The rollout of the vaccine will follow an approval process that hinges on the results from a larger trial, which will be published in the coming months. Both India and China have approved needle-free COVID-19 vaccines­—nasal and inhaled versions, respectively. The nasal version, licensed to Bharat Biotech, was developed by scientists at Washington University in St. Louis. CanSino Biologics has developed the inhaled version, which is a version of their own injected vaccine. Both vaccines use harmless cold viruses although the developers of the nasal version are seeking approval to use the vaccine as a regular and booster dose whereas the inhaled version was only tested as a booster. It is unclear when either vaccine will be available for distribution. These needle-free vaccines are just two of more than ten candidates being studied, as scientists are pursuing needle-free vaccines as a potential strategy to improve protection and make vaccines easier to administer, particularly in low-income countries.A new study published in the journal Radiology looked at Google’s artificial intelligence (AI) model for automating tuberculosis (TB) detection compared to radiologists identifying TB on chest X-rays. The model uses AI to analyze X-ray images to determine which patients should receive follow-up confirmatory molecular testing that is expensive and time-consuming. The AI model could address physician shortages as well as improve TB outcomes and lower costs. While the study revealed promising results across large and diverse patient populations, the model needs to be further tested in real world environments with populations that are older and have more atypical presentations of the disease or other lung abnormalities. A study in a Zambian clinic, which will be finished in the coming months will provide further insight into the potential of the model. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the largest global study on the subject to date. The study, sponsored by the Global Antibiotic Research and Development Partnership (GARDP), which enrolled 3,200 newborns diagnosed with sepsis in 11 countries, found that 11 percent of newborns died over the course of the study and that 15 percent were prescribed last-line antibiotics due to the high degree of resistance to standard recommended antibiotics in treatment units. Antibiotic resistance is now one of the major threats to newborn health globally, according to researchers, with virtually no studies underway to develop novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. GARDP is now designing an interventional trial to identify better treatment regimens to combat rising resistance.World Health Organization (WHO) member states reached a preliminary agreement this week to gradually increase mandatory fees, or “assessed contributions,” to cover 50 percent of the organization’s core budget needs. WHO currently relies heavily on voluntary contributions and private donors, which can leave its financing inflexible and unpredictable. The new funding reforms would be contingent upon certain conditions, such as increased transparency, with the funding linked to a member state review of WHO progress on promised internal reforms. The agreement will still need to be formally approved by governments at the World Health Assembly in May to take effect.COVID-19 diagnostic testing has fallen by 70–90 percent around the world, making it increasingly difficult to monitor the pandemic’s evolution, treat patients, and track variants, according to FIND, a co-convener of the Access to COVID-19 Tools Accelerator diagnostics pillar. While reported cases and deaths are declining globally, changes in testing strategies and reductions in the number of tests being used globally means there is little confidence in actual case trends. The testing decline also undermines the ability to treat patients with new therapeutics—like Pfizer’s antiviral Paxlovid, which requires early diagnosis to get the most benefit—and has led to a decrease in the number of genomic sequences submitted to global databases, which helps track emerging variants.