Breakthroughs Blog: Pandemic preparedness

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.Last week, the US Food and Drug Administration ended the emergency authorization for Eli Lilly’s bebtelovimab, due to new variants against which the treatment is ineffective. Prior to this, bebtelovimab was the only COVID-19 antibody therapy still cleared for use. This news comes after several other antibody therapies were also made ineffective by the growth of new subvariants. While there are other updated antibody therapies in development, they will likely not be authorized for some time. Other COVID-19 treatments, including Paxlovid and Remdesivir, remain available although limitations prevent their wide use. The Coalition for Epidemic Preparedness Innovations (CEPI) has published a new plan for the development of a vaccine for “Disease X,” a pathogen with pandemic potential that has yet been identified. The plan calls for a vaccine within 100 days of the release of its genetic sequence. It was developed in collaboration with international health bodies, vaccine producers, researchers, and regulatory authorities, and identifies steps and investments needed far in advance of the identification of a disease outbreak.New results from a small trial found that a single pill of acoziborole given to participants with sleeping sickness (human African trypanosomiasis) in the late stages of infection has a 95 percent success rate at 18 months posttreatment and a 100 percent success rate among participants with an early-to-intermediary infection. The study, carried out by the Drugs for Neglected Diseases initiative, identifies the dug as a safe, effective oral therapy with incredible strengths compared to the currently used treatment, fexinidazole, which has a lower efficacy rate, must be taken more often, and has several common side effects.

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.Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced plans for a US$1.76 million investment to advance and expand the scope and technology of the Spillover app, a platform created at the University of California, Davis that could be key to identifying and preparing for “Disease X,” a virus with pandemic potential that has yet to be identified. The platform includes a database with more than 500,000 samples from an estimated 74,000 animals in 28 different countries around the world, and CEPI’s investments will further its capabilities to identify viruses that are most likely to spill over to humans. The platform is hoping to use that data to prioritize and streamline investments in a library of vaccines, aimed at protecting against the viral families that pose the greatest threats, that are ready to be adapted against “Disease X” within 100 days of its identification.South Africa will begin piloting a new every-other-month HIV prevention shot as new modelling released last week showed that the shot could prevent as many as 52,000 new infections over the next 20 years if rolled out nationally. The pilot will begin after approval from the South African Health Products Regulatory Authority, which is expected early next year. Two large clinical trials found that the shot was more effective than the oral HIV prevention pill, Truvada, in part because it is taken much less frequently than the daily pill. However, the shot will only be available, at least in the short-term, in small pilot projects, and the high price is still a major barrier to the product being cost-effective in South Africa.Results from the STREAM clinical trial, shared last week at the Union World Conference at Lung Health showed that two shorter treatment regimens for multi-drug resistant tuberculosis (MDR-TB) including a fully oral nine-month bedaquiline-based regimen and a six-month injection-containing regimen have been shown to be safer and more effective that the nine-month regimen, which combines pills and injections, that is still in wide use. The STREAM trial was the largest-ever MDR-TB trial ever conducted with more than 1,000 participants across eight countries. The findings from the trial strengthen the evidence for bedaquiline as a component of improved drug-resistant therapies (bedaquiline is also a component of the six-month BPaL and BPaLM regimens, which were endorsed for use against most forms of drug-resistant tuberculosis in the World Health Organization's rapid communication on tuberculosis treatment guidelines released earlier this year).

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.

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.While the COVID-19 pandemic has led to serious setbacks in progress against tuberculosis (TB) with mortality now rising again after a slow but steady decline before the pandemic, COVID-19 has also demonstrated the feasibility of large-scale investment into the rapid development of urgently needed technologies when political will and a sense of urgency exists. Researchers were working on developing new tests, drugs, and vaccines for TB before the pandemic, including one vaccine candidate currently in advanced clinical trials that was developed by GSK and the Bill & Melinda Gates Foundation. Now, powerful technologies that were employed in the development of vaccines for COVID-19, like messenger ribonucleic acid (mRNA), are starting to be employed against TB, with BioNTech and Pfizer planning trials of an mRNA TB vaccine in the next few months.The World Health Organization (WHO) has published its first-ever list of fungal priority pathogens in response to the expanding geographic range of dangerous fungi due to climate change, the rise in cases of fungal disease during the COVID-19 pandemic, and the growth in resistance of fungal diseases to treatments. The list includes 19 pathogens that have been identified as posing the greatest threat to human health. The goal of publishing the list is to catalyze funding for research into fungal infections, which receives less than 1.5 percent of all funding for infectious diseases, as well as to encourage improvements to the treatment guidelines for these infections.The University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) recently published a draft of a Coronavirus Vaccines Research and Development Roadmap, a project supported by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, for public review and comment. The roadmap, which builds on lessons learned from the development of successful COVID-19 vaccines, identifies strategies to develop effective vaccines for new COVID-19 variants as well as coronaviruses that have yet to emerge. In particular, the roadmap emphasizes the need for durable, broadly protective vaccines that are simple to deliver and that protect against multiple coronaviruses.