Breakthroughs Blog: Access

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. Excision BioTherapeutics is investigating whether a single Crispr infusion can effectively keep HIV at undetectable levels in the body. If effective, this innovation could eliminate the need for daily antiretroviral therapy. The Crispr therapy attempts to disrupt the replication process by targeting regions in the HIV genome that are critical in that process. While antiretroviral drugs can stop the virus from replicating, the Crispr therapy is designed to go further by ensuring that the virus cannot reactivate in the future. The trial aims to enroll nine participants and compare the efficacy of three different dosages. The Medicines Patent Pool has signed a voluntary licensing agreement with Japanese pharmaceutical company Shionogi, to allow low- and middle-income countries (LMICs) rapid access to its COVID-19 antiviral treatment pill, contingent on its regulatory approval. Under the agreement, the Medicines Patent Pool will grant sub-licenses to qualified generic manufacturers to produce the antiviral (ensitrelvir fumaric acid) in 117 LMICs. The candidate, which showed promising results in phase 2/3 trials, could make a significant difference in low-and middle-income countries with low vaccination rates.The Biomedical Advanced Research and Development Authority has granted a multi-year contract to Vir Biotechnology with US$55 million in funding to support its influenza-focused antibody drug that is expected to continue trials soon. The contract also allows for a potential billion-dollar investment for the development of candidates against emerging infectious diseases, including influenza. The funding is aimed at improving pandemic preparedness efforts through investments in technologies that target pathogens with pandemic potential.

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. The World Health Organization (WHO) has announced a clinical trial of one or possibly two experimental vaccines designed to protect against the rare Sudan strain of the Ebola virus that has been identified in the recent, rapid outbreak in Uganda. The trial could begin within weeks depending on the Ugandan government’s permission, which is expected soon, as well as regulatory and ethics review approvals. The trial was announced by the WHO’s Health Emergencies Program, which has been conferring to identify vaccines that are far enough along in their development to undergo clinical testing. There are six vaccine candidates in development that are designed to target the Sudan strain, only half of which have advanced to the stage of human clinical trials. Of those, a candidate developed by the Sabin Vaccine Institute and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases is the furthest along in its development. Dengue resurged across Asia following a period of lower transmission due to reduced mobility because of COVID-19 restrictions, but an exciting vaccine has the potential to make huge strides in reducing the burden of the disease not only in the region but around the world. In August, Indonesia became the first country in the world to approve Takeda’s Qdenga, or TAK-003, vaccine for use against dengue in 6- to 45-year-olds. Qdenga showed incredibly promising results in clinical trials and is under review by the European Medicines Agency and other regulatory agencies in dengue-endemic countries, although it is yet to receive WHO prequalification. The vaccine addresses the complexity of dengue’s four strains by using a weakened version of the DENV 2 strain as its base and including genes from the other three strains.In 2020, a clinical trial in South Africa testing PrEP as a shot delivered every few months found incredible success with results showing high efficacy compared to the daily pill. The drug used in the trial (long-acting cabotegravir or Cab-LA) made by ViiV Healthcare has only been awarded regulatory approval in the United States to date. Access to the shot in low- and middle-income countries has been hampered by the company’s decision to not grant licenses for generic makers to produce the drug at a lower cost. The company has made an agreement with the Medicines Patent Pool that permits three or fewer companies to make generic versions of the drug in 90 low- and middle-income countries, but it could take at least three years for regulatory approval. Viiv Healthcare has submitted its drug for WHO prequalification, which could speed up this approval process. 

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. The Medicines Patent Pool (MPP) and ViiV Healthcare last week announced a new voluntary licensing agreement that would allow for generic manufacturing and distribution of long-acting cabotegravir in an effort to expand access to the HIV prevention drug. Long-acting cabotegravir—an injectable form of preexposure prophylaxis, or PrEP—can provide two months of protection against HIV infection with a single shot, while most other forms of PrEP require daily pills. The new licensing agreement between the United Nations-backed MPP and ViiV will let select generic manufacturers apply for sublicensing to develop, manufacture, and supply generic forms of the drug in 90 countries—pending regulatory approvals—where the HIV burden and potential use of cabotegravir is the highest.The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting an initiative to develop a standardized approach to test the performance of vaccines being used or in development against monkeypox. The new funding, announced days after the World Health Organization declared monkeypox a public health emergency of international concern, will go to the UK Medicines and Healthcare products Regulatory Agency and the UK Health Security Agency to pursue tools able to assess the strength and duration of immune responses generated by current vaccines, as well as for tests used to detect monkeypox antibody levels. These tools will subsequently be made available to the global scientific community for free, apart from administration fees, enabling a standardized assessment between countries documenting vaccine performance against monkeypox, according to CEPI.Researchers have identified a specific area of the SARS-CoV-2 spike protein as a good target for pan-coronavirus vaccines, making a promising advance in the development of a shot to protect against COVID-19 variants and common colds. A universal coronavirus vaccine would need to induce antibodies that recognize and neutralize a wide range of viruses—a challenge, given the complexities of the coronavirus family, according to scientists. In the new study, scientists investigated whether antibodies targeting the S2 subunit of SARS-CoV-2’s spike protein could also neutralize other coronaviruses, including a strain of the common cold as well as several COVID-19 variants, and found promising results among mice. The researchers plan to continue to study the method as potential pan-coronavirus vaccine target and evaluate how it could be integrated with currently licensed vaccines.