Research Roundup: New report on FDA, mRNA TB vaccine, Ugandan Ebola outbreak

The annual opening of the United Nations General Assembly (UNGA) is always a key moment on the diplomatic calendar. For the first time since the COVID-19 pandemic began, UNGA was held in person. This provided opportunities to renew relationships, forge new partnerships, and debate in-depth in ways that are difficult in the Zoom world. And while many want to say that the pandemic is behind us, as President Joe Biden pronounced on his recent 60 Minutes appearance, COVID-19 and the possibility of future health threats still loomed large during the first half of UNGA discussions.Concurrently, leaders gathered for the replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria and to contend with the erosion of progress in other global health areas as a result of resources being diverted to COVID-19. Chief among the backslides are three of the world’s leading infectious killers: HIV, tuberculosis, and malaria, which all suffered setbacks during the pandemic with a reduction in access to testing and treatment coupled with a troubling rise in cases. If that were not enough, the rising threat of antimicrobial resistance was also top of mind for many leaders.Below are some of the key highlights from the first half of UNGA.Major focus on pandemic preparedness and global health architectureWhile some major speeches at UNGA, such as those by German Chancellor Olaf Scholz or US President Joe Biden, barely acknowledged the pandemic, plenty of events and meetings throughout the the first half of UNGA highlighted a sustained and strong focus on current and future health crises.Underscoring the need for a robust discussion on reforms to global political structures and recommendations put forth over the last two years by the Independent Panel for Pandemic Preparedness and Response and the Global Preparedness Monitoring Board, the UNGA overwhelmingly adopted a resolution to hold a high-level meeting at the heads-of-state- and government-level on pandemic preparedness and response no later than the 78th session of UNGA in September 2023. The agreement—co-sponsored by more than 100 countries—instructs the next General Assembly's president to organize the meeting in collaboration with the World Health Organization (WHO) and to “adopt a succinct political declaration aimed at, inter alia, mobilizing political will at the national, regional and international levels for pandemic prevention, preparedness and response.”Discussions were also centered on the future of the Access to COVID-19 Tools Accelerator. Civil society and other global health stakeholders questioned whether Accelerator is winding down, but stakeholders like WHO Special Envoy Dr. Ayoade Alakija assured the community that the framework is simply moving into a new phase. Questions remain on what the initiative will look like post-COVID-19, yet it is clear that there is a desire to retain some of the coordination functions of the framework, even as advocates continue to highlight the stark inequities and the sometimes-mismatched priorities that the framework created, highlighted by the lack of focus and resources for testing in LMICs.Bolstering local manufacturing capacity The COVID-19 pandemic laid bare what stakeholders across the Global South have long known: severe shortages in lifesaving medical products result when low-income countries are left to rely on the Global North and Asia as primary suppliers. The lack of local manufacturing capacity has been a driver of extreme global disparities in access to lifesaving COVID-19 vaccines, diagnostics, drugs, and devices. More than two years into the pandemic, it has become increasingly clear that strengthening health security in low- and middle-income countries (LMICs) will require long-term investments to fortify local capacity.This realization was echoed throughout discussions. Multiple stakeholders and events focused on the need to bolster manufacturing capacity in LMICs. PATH, in partnership with Foreign Policy, explored the investments, partnerships, and models that can inform a strategy for fostering a sustainable African manufacturing industry and distribution networks across the continent, addressing chronic inequities, and strengthening regional health security. At the Clinton Global Initiative, PATH committed to partnering with the African Union to develop principles for drug, vaccine, and diagnostic manufacturing on the African continent. We also witnessed firsthand commitments being made to strengthen this capacity, including by the Distributed Vaccine Manufacturing Collaborative. The Collaborative is co-chaired by Dr. Richard Hatchett from the Coalition for Epidemic Preparedness Innovations and Dr. Victor Dzau from the US National Academy of Medicine in partnership with the World Trade Organization; Gavi; WHO; the Wellcome Trust; Africa Centres for Disease Control and Prevention; the Oswaldo Cruz Foundation, or Fiocruz; and various governments and industry partners. The goal of the Collaborative is to increase vaccine access in LMICs through the establishment of a versatile global vaccine manufacturing network capable of producing vaccines during pandemic and non-pandemic times. Sustainable financing for pandemic preparedness Another focal point of the first half of UNGA was the need for incremental and sustained financing. While the elephant in the room was clearly the Global Fund replenishment, which raised a record-breaking US$14.25 billion, despite falling short of the ultimate target of $18 billion, broader conversations on financing for pandemic preparedness also attracted plenty of attention. COVID-19 has highlighted that the world has consistently underinvested in preparedness and specifically in the frontline health workforce, resilient supply chains, and research and development for new countermeasures including novel vaccines, therapeutics, and other platforms and technologies that can be deployed during a pandemic.Many dialogues prioritized equity, and the idea that regardless of location or income level, all people must be able to access the science, tools, and resources they need to both better prepare for and respond to health crises. Cross-sector leaders, including the World Trade Organization Director-General Ngozi Okonjo-Iweala, came together for a frank conversation about pandemic preparedness, prevention, and response financing needs, and how we can sustainably mobilize resources for the full range of needs.Much of the attention and debate zeroed in on the newly created financial intermediary fund. This fund is meant to provide a dedicated stream of additional, long-term financing to strengthen pandemic prevention, preparedness, and response capabilities and address critical gaps in LMICs through investments and technical support at the national, regional, and global levels. Yet at UNGA, with the backdrop of the recent disparities in the COVID-19 response still fresh, conversations swirled around how the Fund would ensure a broad set of voices were represented, its ability to achieve its full scope given limited catalytic funding, and how it connects to the broader health security architecture.  This year’s formal UNGA agenda did not feature health as prominently as in the past, perhaps a signal that the outsized attention our community has received due to COVID-19 is waning, as concerns about climate change, a global food crisis, and ongoing global conflicts rise on the list of the world’s most pressing challenges. In the coming months, advocates must pivot to ensure that pandemic needs are not forgotten, and that we start to build the fit-for-purpose architecture of the future, while also recommitting to non-COVID-19 health priorities and addressing the backslides we have seen since the onset of the pandemic.

The first annual progress report on the American Pandemic Preparedness Plan (AP3), released earlier this month by the White House Office of Science and Technology Policy (OSTP), builds on the initial AP3 published by OSTP in September 2021 and frames global equity as a keystone of research and development for pandemic preparedness. GHTC applauds the report while acknowledging significant funding and political will are critical to achieving its objectives.The annual report’s emphasis on global equity in product development represents a significant and growing shift in the many plans, frameworks, and strategies issued by the US government to support pandemic preparedness over the past few years. It resonates, for example, with the recently released five-year strategic plan for the Biomedical Advanced Research and Development Authority that includes a greater focus on working with global partners and developing products for diverse populations living in different contexts.Early in the pandemic, the success of many research efforts was defined by the safety, effectiveness, and speed at which a product could be developed. Fortunately, those efforts led to safe and effective first-generation products that were quickly implemented in places with strong health care systems, such as Washington, DC, and Houston, Texas. What was missing, however, were safe and effective first-generation products that could easily meet the needs of people living in places where there are fewer resources, both in the United States and in many other countries. For example, in places with poorly funded health care systems, few highly trained health care workers, and limited refrigeration, it can be especially challenging to access, rapidly distribute, and administer millions of intramuscular vaccines that require ultracold storage.An important part of global health equity is developing products that are designed for and with the communities that will use them. This is true even in pandemic emergencies, and so GHTC advocates for pandemic preparedness research agendas to prioritize the needs of communities in low-resource settings. Safety, effectiveness, and speed are critical—but deliverability, availability, affordability, and ease of administration cannot be afterthoughts saved for the development of second- or third-generation tools.Some language in the AP3 annual progress report aligns with this vision. While the initial AP3 recognized that “vulnerable communities” face the greatest risk in public health emergencies and that the United States must work to strengthen global research systems and coordinate with global research partners, the new report goes further. Its executive summary states that “scientific and technological advances must be paired with public engagement, trust-building, and recognition and resolution of previous harms and challenges in public health.” The report goes on to recognize that for future responses, medical products need to be developed simultaneously with community engagement processes.Perhaps the most significant items in the new report are the key goals that weave in global health and the development of products that are designed for low-resource settings. The goals include:Exercising pandemic preparedness by “addressing infectious and global health challenges” such as influenza, antimicrobial resistance, and other infectious disease threats.Strengthening clinical trial networks and “warm base” research globally to develop next-generation vaccine technologies, therapeutics, and diagnostics, especially in “geographic regions most likely to see emergence of pathogens of pandemic potential.” Supporting diversified manufacturing for vaccines in low- and middle-income countries (LMICs).Developing vaccines that are easier to administer, more efficient to produce, and provoke a broader immune response. Strengthening national regulatory systems in LMICs to facilitate vaccine production. Supporting health care technologies that can be used at home and in remote locations. Developing a better understanding of global product manufacturing capacity and global investments to inform investments in essential medical product manufacturing in LMICs.Developing multiplex, “pathogen-flexible,” and “pathogen-agnostic” diagnostic tests and minimally invasive, simple-to-use diagnostic tests.It must be noted again, however, that although the AP3 annual report outlines laudable goals and provides a strong signal of White House priorities, for many of its goals to be achieved, Congress would need to provide additional funding and authorizations, which GHTC would support.Despite its limitations, the report is a step toward more equitable research agendas for product development and pandemic preparedness. Further US government commitments to such principles would go a long way toward ensuring that in future health crises, those in low-resource settings are not left behind and are able to quickly and equitably benefit from the development of new tools to protect and restore health.