Research Roundup: Collaboration for African-owned vaccine, NTD research funding, and the stagnant antibiotic pipeline

The COVID-19 pandemic has underscored how vital the research and development (R&D) of medical countermeasures is to prevent and combat global health threats. The record-breaking speed at which vaccines, therapeutics, diagnostics, and other tools were developed proved a triumph of modern science. Yet, the pandemic also exposed clear and persistent gaps in our R&D preparedness ecosystem. Absent a crisis, R&D for health preparedness has historically been on the back burner or excluded from preemptive planning to develop local, regional, and global capacities necessary to effectively combat emerging infectious diseases and other health threats. Funding for advanced R&D of medical countermeasures has remained insufficient. And global health security leaders need to crystallize a vision of how to integrate R&D into a broader global preparedness framework. To build a world better equipped to prevent and respond to health threats, we need a more fit-for-purpose, resilient pandemic R&D ecosystem. To achieve that, we must pursue three key areas of reform, as well as recognize the need for these initiatives to support one another:1. Identifying R&D gaps with a strong evidence baseTo solve a problem, you must first understand the nature of it. When COVID-19 hit, not only were there no clear global mechanisms to coordinate and galvanize research efforts to develop vaccines, drugs, and other tools to fight the disease, but we also clearly lacked an understanding and evidence base for what existing R&D and manufacturing capacities existed at a country and regional level, how they could be leveraged to quickly respond to the crisis, and, most importantly, what the major gaps were. While World Health Organization (WHO) frameworks like the International Health Regulations (IHR) and various assessment tools and scorecards existed to help nations assess their health preparedness, none of them sought to comprehensively track R&D readiness metrics. The lack of regionally distributed R&D capabilities deepened inequities in the response, leaving low- and middle-income countries (LMICs) struggling to access the fruits of science, including key supplies and medical countermeasures.As we strive to build a more equity-driven response to future pandemic threats, a stronger evidence base of country-specific data is key to enabling LMICs to highlight and articulate their specific R&D capacity gaps. This will allow for better prioritization of long-term investment in local R&D capacity, ultimately ensuring better access to medical countermeasures. Fortunately, the Global Health Security Agenda (GHSA) exists as a ready-made platform that could support LMICs in both identifying and articulating their R&D capacity gaps and financing needs. GHSA’s new R&D Task Force is in the process of building a metrics tool that countries could utilize to assess and score their pandemic R&D readiness. Through leveraging that evidence base, countries can build a road map for longer-term reforms and a stronger case to guide the allocation and prioritization of future investments in preparedness.2. Developing sustainable financing mechanismsHealth experts from around the world have warned for years that countries, regional bodies, and global institutions must invest more in critical capacities to prevent, detect, and respond to epidemic and pandemic threats. Yet for years, funding for health preparedness, including R&D, has faced a boom-and-bust cycle, with funding surging during a crisis and then subsiding in the aftermath, as funders lose focus on addressing long-term capacity infrastructure. That’s why it is critical, as we consider reforms and new initiatives to strengthen the global health security architecture, that we advance new, more sustainable funding mechanisms to complement national budgets to fill identified preparedness capacity gaps. The proposed Financial Intermediary Fund (FIF) for Pandemic Prevention, Preparedness and Response, which will be housed at the World Bank, is one such exciting prospect. It could address major funding gaps to help LMICs strengthen R&D capabilities. The FIF should be leveraged for investment in coordinated surveillance and rapid development, manufacturing, and equitable delivery of medical countermeasures essential to controlling epidemics and pandemics in every region. While initial resources may be limited, the FIF should seek to bolster all stages of end-to-end product development, ensuring that every country can access the tools and technologies they need to mitigate health threats. The FIF is meant to be a supplementary, long-term fund that will eventually incentivize increased country investments. Integrating a focus on research and innovation within the FIF’s funding priorities from the start is essential to close local and regional R&D capacity gaps. As planning around governance of the FIF advances, GHSA should be given a participatory or coordinating role in this body to help align financing decisions with articulated R&D capacity gaps. 3. Advancing long-term reforms to global governanceAlongside addressing country-specific gaps, reforms must be pursued at a global level to incorporate R&D capacities—including surveillance, laboratory infrastructure, clinical trial, manufacturing, regulatory capabilities, pharmacovigilance, and supply chain management—into international health preparedness and response frameworks. Currently, there is no global framework or process to assess and strengthen national and global R&D readiness within coordinating mechanisms for health security; R&D is not explicitly part of WHO’s IHR or the Joint External Evaluation (JEE).The global community is currently advancing processes to reform the IHR and JEE. As part of that reform, WHO member states should incorporate new indicators into the IHR/JEE designed to specifically assess R&D capabilities, drawing on ideas generated by the GHSA R&D Task Force’s voluntary assessment tool. WHO should also ensure strong linkages between gaps identified and financing directed by the FIF. Additionally, as member states pursue development of a potential new pandemic framework, it is critical that R&D is incorporated as a central pillar to enhance the coordination of research, delineate roles, and ensure clear parameters and standards to facilitate both the development of and access to new tools. The pandemic has shown that systemic gaps continue to stymie the rollout of new technologies to all people, everywhere—perpetuating gross power imbalances between high- and low-income nations and exacerbating entrenched inequalities that have left significant portions of the world’s population without access to lifesaving tools. As we enter year three of the pandemic, it is essential that we do not fall victim to pandemic fatigue, and we seize this moment to enact substantial, meaningful, and coordinated systems change to ensure the world is better equipped to detect, prevent, and respond to pandemic threats. This includes enshrining R&D in global frameworks, securing new sustainable financing for building research capacity, and ensuring that these investments are made based on robust evidence and key metrics that allow countries and global stakeholders to prioritize their preparedness investments. If we fail to make the transformational changes, we will not be ready for the next pandemic. 

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. On Friday, the US Food and Drug Administration (FDA) authorized Moderna’s and Pfizer’s COVID-19 vaccines for children as young as 6 months—making kids under 5 years old eligible for the first time. The decision followed a unanimous recommendation from a panel of independent advisers to the agency to authorize Pfizer’s three-dose vaccine for children 6 months to 4 years and Moderna’s two-dose vaccine for children 6 months to 5 years. The FDA also authorized on Friday Moderna’s vaccine, previously cleared in adults over 18, for children and adolescents ages 6 through 17 years old. Centers for Disease Control and Prevention Director Rochelle Walensky signed off on recommendation of the shots this past weekend, and vaccinations are beginning this week.The South African Health Products Regulatory Authority last week approved a sweet-tasting, heat-stable, “4-in-1” fixed-dose combination of four antiretroviral (ARV) treatments—abacavir, lamivudine, lopinavir, and ritonavir—specifically designed for infants and young children with HIV. The new formulation, developed by Cipla Limited and the Drugs for Neglected Diseases initiative (DNDi), does not require refrigeration, has a sweet taste, and is easy to administer to infants and children of different weights and ages, making it a significant improvement over existing pediatric ARV formulations. The accelerated review in South Africa is notable and encouraging for other countries with a high burden of HIV, according to DNDi, which also expressed hope that the necessary steps will be taken to ensure the broadest possible access to the treatment for children who need it.Japanese drugmaker Shionogi and the Global Antibiotic Research and Development Partnership (GARDP) announced Wednesday an agreement to expand access to a novel antibiotic for drug-resistant infections in lower-resource countries. The deal aims to provide access to cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, in countries that have experienced delayed or limited access to newer antibiotics. Under the agreement, GARDP will work with partners to manufacture and commercialize the antibiotic, developed by Shionogi, in up to 135 countries. The Clinton Health Access Initiative will also help navigate the technical, regulatory, legal, and economic barriers to getting the antibiotic to patients in these countries.