Research Roundup: "Disease X" platform, HIV prevention shots, and shorter TB regimen

The 2022 midterm elections on November 8 were expected to deliver a decisive power flip from Democrats to Republicans. However, as the new landscape comes into focus, it appears that Democrats will hold the Senate, and Republicans are likely to win the House of Representatives by a handful of seats. These margins and the composition of new committees will determine the trajectory of global health research and development policy over the next two years.Both chambers on a knife edge splitRepublicans underperformed most analysts’ projections in both chambers. In the House, they are expected to eke into power by only a handful of seats. In the Senate—where several Republican candidates failed to overtake their competitors in close races—Democrats have retained control and may even net gain one seat, depending on the outcome of a special runoff election in Georgia on Tuesday, December 6, between incumbent Senator Raphael Warnock (D) and Herschel Walker (R).Implications on makeup of key committeesNext steps for both parties include electing new party leaders, which is expected to happen later this year. Following that, early next year, the parties will designate committee assignments, which will impact oversight and policymaking for the next two years of global health research. In the House, committee majorities will be determined by who holds the majority in the full House. In the Senate, if the final split is 50-50, then committees will also be evenly split. But if Senator Raphael Warnock wins his reelection in Georgia, then the Senate will be 51-49, and Democrats will take the majority on each committee with one extra seat.Though we do not yet know exactly how the committees will look next year, we do know which members from the 117th Congress will return to the 118th and which current members will be stepping down.Leadership of most committees relevant to global health research and development (R&D) are expected to remain relatively stable with top Democrats and Republicans trading positions as chairs and ranking members. Some exceptions include Representative Karen Bass, chairwoman of the Subcommittee on Africa, Global Health, Global Human Rights and International Organizations, who is stepping down in pursuit of becoming the next mayor of Los Angeles and Rep. Hal Rogers (R-KY), ranking member of the House Appropriations State, Foreign Operations, and Related Agencies Subcommittee, who may become chair of the subcommittee or may be replaced by Rep. Mario Diaz-Balart (R-FL).Among the members currently serving on the House Foreign Affairs Committee who have retained their Congressional seats are Reps. Susan Wild (D-PA), Maria Elvira Salazar (R-FL), Young Kim (R-CA), and Abigail Spanberger (D-VA). Members who were defeated include Reps. Tom Malinowski (D-NJ) and Steve Chabot (R-OH). Some other members of Congress on relevant appropriating and authorizing committees to global health research who are retiring or lost their primaries earlier this year include Reps. Albio Sires (D-NJ), David Price (D-NC), Lucille Roybal-Allard (D-CA), Cheri Bustos (D-IL), Jaime Herrera-Beutler (R-WA) and Fred Upton (R-MI). In the Senate:There were no major losses among incumbents on the Foreign Relations Committee; Health, Education, Labor, and Pensions (HELP) Committee; or the Appropriations Labor, Health, nor on the Human Services, Education, and Related Programs (LHHS) and State and Foreign Operations subcommittees. Some big names will be retiring, including Sens. Richard Shelby (R-AL), ranking member on the Appropriations Committee; Roy Blunt (R-MO), ranking member on the LHHS Subcommittee; Richard Burr (R-NC), ranking member on the HELP Committee; and Rob Portman (R-OH).Some leadership changes are expected. Sen. Patty Murray, previous chair of the Senate HELP Committee, is expected to become the head of the Senate Appropriations Committee. The Senate HELP Committee will likely be led by Sen. Bernie Sanders (I-VT) and Sen. Rand Paul (R-KY) or Sen. Bill Cassidy (R-LA). The Senate LHHS subcommittee may be led by Sen. Joe Manchin (D-WV) and Sen. Marco Rubio (R-FL). Both 2022 GHTC Innovating for Impact award winners, Sen. Sherrod Brown (D-OH) and Sen. Todd Young (R-IN) retained their seats.  A potentially challenging landscapeWith Democrats elected to retain control of the Senate in the 118th Congress, leadership in both parties of the current Congress may be more interested in passing an end-of-year funding package so that the 118th Congress can begin with a clean slate. The same may not be true next year, though. If Republicans have a slim majority in the House as projected, it could empower more conservative members to dangle threats to regular governance, such as annual passage of an appropriations package, as bargaining chips—a threat some members have already referenced. Such a dynamic may also lead to hardball negotiations over raising the debt ceiling, a final agreement on which is due in July of next year. Ultimately, these dynamics could limit the potential for global health R&D funding growth in the next two years, despite the need for greater resources. Beyond the funding picture, if Republicans win control the House, they plan to increase oversight over many US government agencies, including several public health and research agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention. Oversight over the executive branch is a critical function of Congress, but aggressive oversight can also threaten the basic functioning of these agencies as staff efforts are redirected. This could ultimately impact the pace of progress for global health research and science in general.Looking aheadGlobal health R&D has historically received bipartisan support, yet this will be the first Congress to be seated after the COVID-19 pandemic, a global health catastrophe that has provoked some policymakers to question the value of certain types of research and the global health status quo. The results of this election are still being finalized, but regardless of who is in charge, there will remain opportunities for crafting and passing good policy. Whether progress happens and at what pace will largely depend on the ability of advocates to make the bipartisan case for why global health R&D is a force multiplier for creating a healthier and safer future for Americans and all global citizens.  

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.