Breakthroughs Blog: Access

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 (CEPI) announced an up-to-US$50 million investment over ten years in building the vaccine development capacity of Senegal’s Institut Pasteur. Following Africa’s major challenges in accessing COVID-19 vaccines during the pandemic, the investment aims to ensure the production of vaccines for low- and middle-income countries during future health crises, and to increase African autonomy over regional health security efforts. The first round of funding includes $15 million over three years, which will fund the development of manufacturing facilities. Last week at the World Economic Forum’s annual meeting in Davos, the World Health Organization (WHO) announced plans to set up a new TB Vaccine Accelerator Council to catalyze the development of tuberculosis (TB) vaccines. In launching the plan, WHO Director-General Dr. Tedros Adhanom Ghebreyesus noted the lesson learned during the pandemic that global, cross-sector commitments and partnerships can accelerate the vaccine research and development process. In addition to stressing the importance of strong TB programs and commitments from high-burden countries, the speakers at the launch event urged countries to renew their commitment toward combating TB by reinvigorating research efforts that have been historically stagnant.Also, at the meeting in Davos, Pfizer announced that it will make its entire portfolio of 500 drugs and vaccines available to 45 low-income countries at nonprofit prices. This collection of medical technologies includes patented and off-patient medicines, a range of antibiotics, as well as new vaccines and medicines as they are launched. This effort is an expansion of last year’s “An Accord for a Healthier World” initiative, which focused on a smaller number of patented products, including the COVID antiviral treatment Paxlovid. The initiative will provide more than a billion people access to important products, hopefully helping to address major global health challenges, including antimicrobial resistance which has arisen in part, due to challenges accessing a broad scope of treatments.

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) recently added Indian company Hetero’s generic version of Paxlovid (Pfizer’s COVID-19 antiviral) to its prequalification list. Hetero also announced a licensing agreement with the Medicines Patent Pool to manufacture and sell the generic version in low- and middle-income countries. WHO’s inclusion will hopefully improve access for the drug, which the agency has strongly recommended for the treatment of high-risk patients with mild and moderate COVID-19, but which has been largely inaccessible to patients in low- and middle-income countries.Recent findings published in the New England Journal of Medicine found that initial results from two phase 2 clinical trials showed that two vaccines (Ad26.ZEBOV (Ad26) followed by MVA-BN-Filo (MVA) 56 days later and rVSVΔG-ZEBOV-GP (rVSV)) given with or without a booster dose 56 days later) against the Zaire strain of Ebola virus are safe and well-tolerated in adults and children. Both vaccines produced antibody responses as soon as two weeks after administration of the first dose that lasted for at least a year. As part of the PREVAC study in West Africa, these trials aim to assess the safety and efficacy of different experimental vaccine regimens for Ebola Zaire vaccines in order to reduce the high mortality associated with Zaire outbreaks.An innovative, new vaccine for HIV developed by the Scripps Research Institute in collaboration with the Fred Hutchinson Cancer Center, the International AIDS Vaccine Initiative, and the US Institute of Allergies and Infectious Diseases, among others, has demonstrated promising results in its first immunogenicity trial in humans. In response to HIV exposure, the vaccine, called eOD-GT8, is designed to induce a type of broadly neutralizing antibodies that can block a specific part of the virus that is needed for it to enter certain cells. While extensive further research and many further challenges remain, the recent results do demonstrate the potential of a complex and innovative approach.

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, Medicines for Malaria Venture and the Africa Centres for Disease Control and Prevention (CDC) signed a memorandum of understanding for providing technical support to African manufacturers for the development of antimalarial drugs. The support is aimed at helping improve the quality of antimalarial products to meet World Health Organization’s (WHO’s) standards in order to increase the use of locally produced drugs and make them eligible for bulk procurement by global institutions, as well as to address the high burden of malaria on the continent. This effort is also part of a wider initiative to increase African manufacturing after COVID-19 uncovered the risks of the continent’s over-reliance on imported drugs. The Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) are investing US$30 million in Aspen Pharmacare Holdings Limited to support the manufacturing of routine and outbreak vaccines for Africa. Through a ten-year agreement with the Serum Institute of India, Aspen will use the investment to manufacture and distribute the routine Pneumococcal, Rotavirus, Polyvalent Meningococcal, and Hexavalent vaccines, as well as support technology-transfer activities and build regional vaccine manufacturing capacity for potential future outbreaks. The investment underlies a wider effort to ensure vaccine manufacturing capacity and supply of affordable vaccines on the continent. Joining a growing call for action in response to the increasing threat of antibiotic resistance, WHO recently published the Global antimicrobial resistance and use surveillance system (‎GLASS)‎ report: 2022, which identified a high level of antibiotic resistance in bacteria that can cause fatal bloodstream infections and an increasing level of resistance in bacteria that can cause common infections. The report echoes a wider concern about the need for the development of new antibiotics for newborn babies to address the up to 570,000 deaths and estimated three million cases of neonatal sepsis each year, many of which occur in the absence of effective antibiotics due to rising antimicrobial resistance.

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.