Breakthroughs Blog: DoD

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. Recently published results from a Phase 3 clinical trial support Pfizer and Abbvie’s aztreonam-avibactam as a potential treatment for patients with serious gram-negative bacterial infections and limited treatment options. Aztreonam-avibactam is a combination of two antibiotic drugs that work together to effectively fight off tricky bacteria resistant to nearly all currently available antibiotics. The treatment was approved in April by the European Medicines Agency based on the results of two previous Phase 3 clinical trials that investigated the treatment's efficacy in treating several types of multidrug-resistant infections.Last week, TB Alliance announced the award of a $7.35 million four-year grant from the US Department of Defense’s Congressionally Directed Medical Research Programs for the research and development of host-directed approaches for treating tuberculosis (TB). Host-directed approaches, which target the immune response of the host (the infected person) rather than directly targeting the bacteria, could reduce the likelihood of the emergence of drug resistance and, in combination with new TB drugs, could offer shorter and less long and burdensome treatment regimens for those with drug-resistance and drug-sensitive TB. Specifically, the project will work toward preclinical proof-of-concept for at least one novel adjunct TB host-directed therapy and one therapeutic vaccine.At the HIV Research for Prevention Conference last week, the Population Council announced the results of a Phase 1 trial conducted in South Africa, which suggest that the three-month dapivirine vaginal ring for HIV prevention will be as effective as the one-month ring. The three-month dapivirine vaginal ring, a flexible silicon ring self-inserted into the vagina that slowly releases an antiretroviral drug to prevent HIV infection, was found to deliver the drug at higher levels than the one-month ring. If the longer-acting ring continues to demonstrate success in future trials, it could offer a more cost-effective and convenient option for women—it is expected to reduce the cost per user by 60 percent.  

Nearly six months into fiscal year 2024 (FY24), the US government has finally agreed upon a budget for the remaining six months. Nevertheless, March brings with it a new appropriations cycle forcibly run in parallel with the last. With the release of the President’s Budget Request (PBR) for fiscal year 2025 (FY25) and ongoing meetings with appropriations staff, the prospects for future US spending on global health research and development (R&D) are coming into focus, with both good and bad on the horizon.FY24 spending package: A mixed bag for global health R&D This year’s appropriations process was certainly one for the history books in that it was historically difficult—largely due to partisan divisions and threats to the House speakership. But on March 22, moments before a partial government shutdown was set to go into effect, a six-bill “minibus” was voted through by the House of Representatives and the Senate and later signed into law, which will keep the government operational until September 30. This second spending package included funding bills for Labor, Health and Human Services, Education, and Related Agencies (LHHS); State, Foreign Operations, and Related Programs (SFOPS); and Defense, which are a mixed bag for funding for global health R&D.LHHSThe LHHS bill, which covers funding for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA), included some welcome increases to agencies and programs that support global health research alongside overall stagnant funding.Out of the three agencies, BARDA, which focuses on the R&D of countermeasures against emerging health threats, received the largest increase in funding with a $65 million (6.8 percent) boost over fiscal year 2023 (FY23) levels, bringing its total budget to $1.015 billion. The CDC, America’s lead public health agency, and NIH, the primary agency responsible for biomedical health research, witnessed marginal adjustments, with their budget lines most relevant to global health R&D remaining largely static. Notably, CDC's National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) received a $9.5 million (1.27 percent) boost, which will help bolster crucial surveillance initiatives such as the Advanced Molecular Detection program.  Additionally, the minibus also included complimentary directives, known as report language, which were championed by GHTC, that reinforce the importance of global health and neglected disease research taking place at CDC and NIH. It also included important language encouraging BARDA to consider the needs of people living in low-resource settings in its R&D funding decisions and directing the agency to provide more transparent and regular reporting on its investments and allocate at least $10 million of its budget to create a new Disease X medical countermeasures program to develop tools against viral families with pandemic potential.SFOPSThe SFOPS bill covers global health work undertaken by the US Agency for International Development (USAID) and the US Department of State (State). Unfortunately, the FY24 spending package included a significant cut of $530.95 million (5.3 percent) to State and USAID global health programs.Much of this reduction is due to a decrease in funding by $350 million for the US contribution to The Global Fund to Fight AIDS, Tuberculosis and Malaria, which fell from $2 billion in FY23 to $1.65 billion in FY24. While this is a large cut, it was both expected and supported by advocates, given that US law caps the maximum contribution that the United States can make to the fund relative to the contributions of other donors. Thus, the “cut” was implemented in line with the cap to avoid a harsh drop-off in US funding in the coming years. Accordingly, many advocates are not viewing it as an actual cut. The remaining decrease in funding comes from a significant $200 million (22 percent) cut to USAID Global Health Security (GHS). The FY24 funding for GHS of $700 million retains a $100 million carve-out for a US contribution to the Coalition for Epidemic Preparedness Innovations, or CEPI, but advocates are still piecing together what the $200 million slash could mean for other GHS programming. This picture is further complicated by the opaque nature of how the US government intends to fund a contribution to the World Bank Pandemic Fund, which is neither specified in the bill in terms of a funding number nor in the programmatic budget line. The Biden Administration announced last year its intent to contribute $250 million to the fund, but this contribution is not actually detailed in the spending package, so it remains unclear how this commitment will be realized. Slightly cushioning the overall cut to State and USAID global health programs are some modest increases to the budget lines for the maternal and child health (through an increase in funding to GAVI, the Vaccine Alliance), nutrition, and other public health threats programs.In a key win for global health research advocates, Congress also included accompanying report language for SFOPS directing USAID to increase its spending for health R&D over the prior fiscal year and to publish an annual report on its health R&D activities and investments. Notably, the reauthorization of the US President’s Emergency Plan for AIDS Relief, or PEPFAR, was also included in the SFOPS bill but only for one year, so authorization will expire next March. This one-year reauthorization tees up another battle, which will certainly be shaped by the political climate and controlling parties following the presidential and congressional elections this fall.DefenseWhile few may think of the US Department of Defense (DoD) as a key global health player, the agency’s spending supports R&D against epidemic-prone diseases and other health issues that pose a risk to US national security and service members stationed abroad—so its investments contribute to combating diseases endemic in many of the world’s poorest places. Encouragingly, language supporting DoD's research on infectious diseases and the development of medical countermeasures was included in the accompanying Defense bill report.Unfortunately, however, Congress did not include tuberculosis among the diseases eligible to be funded via the DoD-led Congressionally Directed Medical Research Program’s (CDMRP’s) Peer Reviewed Medical Research Program (PRMRP), as has been the case in years past. This is a point of future advocacy since the CDMRP PRMRP funds other neglected and emerging diseases in line with the list of eligible diseases defined in the Senate’s Defense bill each year.FY25 President’s Budget: A story of lowered ambitionOn March 11, President Joe Biden released his FY25 budget request, outlining his administration's recommendations to Congress for spending for the next fiscal year. The FY25 PBR is more moderate than Biden’s FY24 proposal, which can be largely attributed to the administration upholding their end of the debt ceiling bargain to keep overall spending levels capped at roughly FY23 levels. But even still, the lack of boldness for global health activities across the board was felt by advocates.With respect to global health programs at State and USAID, the budget proposes an overall decrease of approximately $733 million (7 percent) compared to FY23 enacted levels. This includes a $175 million (4.2 percent) cut to USAID and a $558 million (8.9 percent) cut to State global health programs. Concerning the latter, the cut comes from the PBR proposing a $1.19 billion contribution to the Global Fund, which would be an $810 million reduction from FY23 levels. As previously noted, this drastic cut is due in large part to the cap imposed on maximum US contributions; however, advocates are still pushing for $1.65 billion in FY25, citing projections that the US contribution can be set higher without violating the cap. The proposed USAID cut is more nuanced and comes from an accounting choice by the administration to transfer funding for the US contribution to the Pandemic Fund ($250 million) from under the Global Health Security line at USAID to the budget for State’s new Bureau of Global Health Security and Diplomacy, which will now manage US engagement with the fund. In conversations with the agency, the movement of this funding is not being perceived as a cut—leaving USAID’s global health programs largely untouched in the PBR. Most programs are flat funded, though the budget proposes a modest $30 million (3.3 percent) boost to USAID’s maternal and child health programs and a reduction of $26 million (4.5 percent) to USAID’s family planning account.On the LHHS side, the budget proposal is slightly rosier, though far from ambitious. The PBR proposes increases of $20 million (2.1 percent) for BARDA and $1.4 billion (2.3 percent) for NIH overall, with the latter including a modest boost of $18.72 million (0.3 percent) for NIH’s National Institute of Allergy and Infectious Diseases but flat funding for NIH’s Fogarty International Center, which supports global health research and training. CDC received a proposed increase of $465.4 million (5 percent) in the PBR, with NCEZID receiving a $30 million (4 percent) increase and the Center for Global Health flat funded.Notably, CDC’s congressional budget justification proposes that $20 million of this funding for NCEZID be put towards wastewater surveillance, which is programming that is currently being supported unsustainably via emergency funding for the COVID-19 response. Additionally, in the BARDA congressional budget justification, the administration suggests a $20 million boost “to increase BARDA’s Broad Spectrum Antimicrobials and Combatting Antibiotic-Resistant Bacteria portfolio" through engagement with the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, an international partnership focused on accelerating the development of new antibacterial innovations.While GHTC understands the administration’s fiscal situation and negotiating position with Congress, the discrepancy between the administration’s ambitions from the FY24 PBR to the FY25 PBR are stark, with some agencies seeing decreases of over $1 billion between the two presidential requests.FY25 outlook: Not great, but not badWhile it may feel cruel for advocates, there is no breathing room between the FY24 and FY25 appropriations processes. Additionally, the constraints the global health community felt in 2024 in the wake of the Fiscal Responsibility Act of 2023—also known as the Biden-McCarthy Debt Ceiling Deal that capped spending growth—are still with us. Even though the outcomes of the FY24 spending package were discouraging for global health advocates—it went better than many expected. For FY25, while a robust and bold global and public health budget is the goal—holding off any cuts and returning to FY23 topline budgets for global health programs will be critical. GHTC will be working to communicate that message clearly while keeping in mind the uphill battle caused by the parameters forced upon appropriators by last June’s debt ceiling deal.Other obstacles like election-year politicking and a remarkable loss in global health champions in Congress will make future negotiations harder and will require advocates to go more on the offense. Pushing for stronger toplines and no cuts will be vital in FY25 to get the gains the community needs to get the world back on track toward eradicating neglected diseases and better preparing for emerging threats.

In recognition of World Mosquito Day on August 20, 2021, GHTC is testing our readers’ knowledge of mosquito-borne diseases and ongoing efforts to develop treatments, vaccines, vector-control innovations, and other tools to outsmart the world’s deadliest animal. Find out if you have achieved mozzie mastery by taking our quiz below. Loading...(function(i,s,o,g,r,a,m){var ql=document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if(ql){if(ql.length){for(var k=0;k

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 US Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.