Breakthroughs Blog: CDC

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 Food and Drug Administration granted Fast Track authorization to LimmaTech Biologics' vaccine candidate targeting the Staphylococcus aureus bacterium, which is a major source of sickness and death around the world, causing infections that are becoming harder to treat as the pathogen develops resistance to traditional antibiotic treatments. There is currently no vaccine to prevent infections caused by S. aureus. The authorization will expedite the review process for the product, which will undergo Phase 1 clinical trial testing later this year.  In two Phase 3 trials, a new combination treatment for patients with virologically suppressed HIV-1 demonstrated promising results, underlining the potential of islatravir in combination with other antiretrovirals to address the treatment needs of people living with HIV. The once-daily, oral, two-drug, single-tablet regimen consists of the investigational drug islatravir and doravirine, which was approved in 2018 as a single-agent treatment and in combination with other drugs. Islatravir is also being studied in other early- and late-stage HIV combination treatment trials.  A recently published study found that an mRNA vaccine designed by the US Centers for Disease Control and Prevention and Moderna successfully protected ferrets from the avian influenza virus, which continues its worrying spread across the United States. Blood serum taken from immunized ferrets was also able to neutralize a sample of the virus taken from a patient who contracted bird flu after coming into contact with dairy cows, which have been at the center of the outbreak. While there are three avian influenza vaccines approved in the United States, they were designed for past variants of the virus rather than the clade behind the current outbreak, and they are not mRNA vaccines, which, as demonstrated during the COVID-19 pandemic, can be rapidly produced and scaled up in the face of an emergency.

In many ways, 2024 has been a year marked by change—the first new year since the official end of the COVID-19 pandemic and a record number of elections ushering in political transitions around the world. With the global spotlight shifting to antimicrobial resistance (AMR) and tuberculosis (TB) reclaiming the designation as the top infectious disease killer from COVID-19, it may seem, at first glance, that the world has moved on from the pandemic that dominated every aspect of life for the better part of four years. However, with a deeper look, it’s clear that the global community is still reacting to and learning from the pandemic—for better or worse.As the year comes to an end, GHTC is reflecting on the global health innovation news and policies that shaped 2024.1. New disease outbreaks arise around the world, spurring need for and progress in R&D.In 2024, disease outbreaks continued to dominate the headlines—from the first reports of avian flu in the United States in March to the rapid global spread of the clade 1b mpox strain over the summer to the outbreak of the deadly Marburg virus in Rwanda beginning in September. Each of these incidents exposed devastating gaps in our prevention and response toolkit and spurred important steps forward on research and development (R&D) and access.For example, in response to the worrisome spread of avian flu, both the World Health Organization (WHO) and the US government launched efforts to accelerate the development of mRNA vaccines that could be deployed in case of human-to-human transmission of the currently spreading strain of avian flu or redirected to target another form of pandemic influenza if needed. Additionally, following declarations from the Africa Centres for Disease Control and Prevention and WHO designating mpox a public health emergency this past August, WHO prequalified the first vaccine against mpox and approved the first mpox test for emergency use, with the goal of accelerating global access to these critically needed tools. The outbreak also provoked new research to develop improved vaccines against mpox and the broader range of orthopox viruses, with early studies of mRNA mpox vaccines in macaques and mice demonstrating promising results.This fall, as cases of Marburg were on the rise in Rwanda, and with no currently approved vaccines or treatments available, researchers fast-tracked efforts to evaluate tools to stem the current outbreak and curb future ones. Rwandan health authorities initiated an open label vaccine trial in health workers and others at heightened risk, and there has since been a randomized clinical trial arm launched, which will offer critical efficacy data. Additionally, scientists launched the first-ever clinical trial for a Marburg treatment this year.Beyond accelerating innovation against these outbreaks, 2024 also brought exciting research advancements targeting other pathogens scientists believe are most likely to cause the next pandemic, including trials that could lead to the first-ever approved vaccines for Sudan ebolavirus and Lassa fever, as well as further efforts to improve coronavirus vaccines and simplify and speed up vaccine development and manufacturing.2. Pandemic preparedness policy reforms march forward while post-COVID political backlash in United States grows.Multilateral efforts to strengthen the world’s pandemic preparedness and response architecture moved incrementally forward this year. At the World Health Assembly (WHA) in May, member states adopted several amendments to the International Health Regulations—an existing framework codifying international responsibilities during a pandemic—, including new commitments to solidarity and equity on financing and ensuring access to medical products. The World Bank-hosted Pandemic Fund, a financing mechanism launched in 2022 to help low- and middle-income countries strengthen their preparedness and response capacities, also raised $982 million in new contributions and an additional $1.8 billion in co-financing this year, as well as awarded $500 million in grants to countries to strengthen surveillance, laboratory, and workforce capacities and fast-tracked an additional $129 million for the mpox response. Under the Brazilian presidency, G20 nations established a voluntary coalition to strengthen local and regional production of health products, which, while focused foremost on neglected diseases, could also strengthen capacities critical for pandemic preparedness and response. Unfortunately, despite some progress on negotiations toward a new pandemic accord, countries failed to reach sufficient consensus before the end of this year, and negotiators are now pushing to wrap up by the next WHA in May of 2025.At the same time as some progress was achieved on the international front, in the United States, post-COVID political backlash has deepened and become more entrenched through congressional scrutiny and reform agendas targeting the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Though the fiscal year 2025 budget is not expected to be finalized until next year, the health-related spending bill introduced by the House proposes spending cuts to CDC and a reorganization of NIH, which mirrors that put forward by House Republicans over the summer and could have serious implications for the agency’s core global health R&D capacities. Beyond appropriations, we also continued to see a plethora of congressional hearings targeting NIH and CDC on the origins of COVID-19, gain-of-function research, China’s influence, and the perception that these agencies are overstepping their mandates. The scrutiny and reform efforts we saw this year are expected to intensify in 2025, as Republicans gain control of both chambers of Congress and the White House.3. AMR captures the world’s attention as the global threat continues to grow.2024 was informally dubbed “the year of AMR,” with AMR elevated on the global agenda at several key moments. In May, a WHA resolution was adopted to accelerate national and global responses to AMR by advancing R&D, strengthening surveillance systems, and forging international partnerships. Later in September, a landmark report found that without further policy interventions, the death toll from AMR is expected to reach 39 million between 2025 and 2050—the equivalent of three deaths per minute.This shocking report set the scene for the United Nations High-Level Meeting on AMR in September, which led to the adoption of a political declaration that set the goal to reduce AMR deaths by 10 percent by 2030 and committed countries to promote the R&D of and equitable access to antimicrobials, vaccines, diagnostics, and other products. Global leaders also adopted an action plan in November, built off of the declaration, to provide actionable objectives and additional check-ins to monitor progress.This political momentum on AMR was also matched by exciting research breakthroughs that made the news this year. Researchers discovered a new compound that could potentially treat a resistant bacterial pathogen that can cause lethal hospital infections. Additionally, Phase 3 trials yielded promising results for both a therapeutic option for patients with serious bacterial infections and limited treatment options, as well as a new antibiotic that could cure uncomplicated gonorrhea infections, which could be approved sometime next year.4. TB reclaims title of deadliest infectious disease, but promising trials offer hope. This past year, TB surpassed COVID-19 to reclaim the spot as the world’s leading infectious disease killer, according to WHO’s Global Tuberculosis Report 2024. While this sobering news underscored major gaps in the tools needed to prevent, diagnose, and treat TB, especially drug-resistant TB, 2024 also brought exciting news on the research front that will hopefully help fill them.In March, a Phase 3 trial launched in South Africa, which is testing a TB vaccine candidate that could eventually become the first vaccine to prevent pulmonary TB in adolescents and adults. The only approved TB vaccine on the market, which was developed more than 100 years ago, is effective at preventing some types of TB in infants, but it offers inconsistent protection in adults against pulmonary TB. Additionally in November, the endTB consortium announced the completion of the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant TB, a very hard-to-treat form of TB. Preliminary results demonstrated that a shorter, less toxic treatment strategy achieved high cure rates. Earlier in the year, WHO also recommended three new regimens for multidrug- or rifampicin-resistant TB, offering a much-needed variety of therapeutic alternatives for those with multidrug-resistant TB. 5. A major HIV breakthrough, but work remains on access. In what has been hailed as a breakthrough in HIV prevention, in 2024, exciting results were reported from a series of clinical trials for Gilead’s long-acting HIV prevention drug, lenacapavir, which found that the drug was 100 percent effective in preventing HIV in cisgender women and adolescent girls and 96 percent effective among cisgender men, transgender men and women, and gender nonbinary individuals who have sex with men. Both trials were so successful that they were unblinded early to offer the drug to all participants. Lenacapavir, which is administered via a twice-yearly injection, is currently approved as a treatment for multidrug-resistant HIV, but, if approved as a preventative regimen, the drug could be a game-changer for the HIV pandemic.Advocates applauded Gilead for its historic commitment to inclusion in these trials, while also urging that lenacapavir be made accessible and affordable as soon as possible to those that most need it. In October, Gilead announced a plan to allow generic versions of the drug to be sold in 120 countries, including all those with the highest HIV rates. However, the plan faced criticism for excluding most middle- and high-income countries that account for around 20 percent of new HIV infections. In these countries, the originator drug will only be available at higher prices, making it potentially inaccessible to at-risk populations.In other welcome HIV prevention news, in October, Population Council announced the results of a Phase 1 trial, which suggest that a three-month dapivirine vaginal ring for HIV prevention will be as effective as the currently approved one-month ring. The ring, which is self-inserted into the vagina and slowly releases an antiretroviral drug to prevent infection over three months, was found to deliver the drug at higher levels than the one-month ring. If the longer-acting ring continues to demonstrate success, it could offer a more cost-effective and convenient option for at-risk women. 6. Trump presidency and Republican trifecta portend changes to US leadership in global health.In the November election in the United States, former President Donald Trump won the presidency and Republicans gained control of both the US House of Representatives and the Senate. It was an across-the-board victory that will portend changes to US leadership on global health and medical research. If past is prologue, we’re likely to see President-elect Trump once again propose significant funding cuts to US global health programs and public health agencies like NIH and CDC, as well as withdraw the United States from WHO and other multilateral initiatives, the latter of which could derail efforts to finalize a pandemic accord. Given that the United States is the largest funder of global health programs and global health R&D efforts, these political changes could have a reverberating impact on health around the world.Since winning the presidency, President-elect Trump has also nominated several controversial picks to lead America’s public health agencies. These include Robert F. Kennedy Jr, a noted vaccine skeptic who has expressed a desire to cut the NIH workforce and refocus the agency on chronic diseases over infectious diseases, to lead the Department of Health and Human Services; Dr. Jay Bhattacharya, a health economist who criticized public health measures during the COVID-19 response and a vocal critic of NIH, to lead NIH; and Dr. Dave Weldon, a former Congressman who has questioned vaccine safety, to lead CDC.On the congressional front, with Republicans now in control of both chambers of the US Congress, as discussed, we’ll likely see continued scrutiny and reform efforts targeting NIH and CDC, as well as potential spending cuts to health and foreign assistance programs.7. New policies and innovative research approaches help reach underserved populations.Every person, everywhere, deserves to benefit from the fruits of science, and in this otherwise tumultuous year, there were several successful efforts to advance more inclusive clinical studies. In September, WHO released new guidance on clinical trial best practices outlining practical considerations for trials to include children and pregnant and lactating individuals, populations currently underrepresented in trials, leading to a lack of approved technologies for these groups. This guidance aligned with WHO’s living toolkit to facilitate the inclusion of pregnant and breastfeeding populations in clinical trials that was published earlier in the year. 2024 also brought the launch of two historic trials that aim to diversify research and thereby ensure that future technologies will serve the needs of underserved populations. This summer, a global consortium launched the first-ever Phase 3 clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will hopefully not only lead to an urgently needed new treatment option for these women but also set a precedent for the inclusion of pregnant women in future clinical trials. Earlier this year, the US Administration for Strategic Preparedness and Response also announced funding to Walgreens to support a decentralized clinical trial testing COVID-19 vaccines. This unique approach will allow for a more diverse pool of study participants by bringing the study closer to where they live, ultimately ensuring that the resulting data reflects real-world use among a broader swath of the population. In the end, 2024 proved to be a complicated year, marked by both scientific and political steps forward and back. As new innovations and policies emerge in 2025 and beyond, GHTC will continue to work to ensure support for global health R&D remains a political priority and that the gains we have already made on neglected and emerging health challenges are not only sustained but also strengthened to combat an evolving health landscape.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2025 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter.

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. A study published last week and presented at the American Society of Tropical Medicine & Hygiene’s (ASTMH’s) annual meeting found that the malaria parasite is acquiring partial resistance to artemisinin, a key drug used to treat children with severe malaria, meaning that infection takes longer to clear and is not always being completely cleared by the drug. The researchers found partial resistance to the drug in 11 of the 100 children treated in the study, with 10 patients “cured” of severe malaria having a resurgence of the same strain within a month of the original infection, implying that the first treatment did not fully eliminate the parasite. More studies are needed to determine how widespread artemisinin resistance is in Africa. Still, the findings underscore the need for novel or alternative drugs to be used in the treatment of severe malariaThe US Centers for Disease Control and Prevention (CDC) has awarded Alveo Technologies a contract to develop a molecular assay to detect and differentiate the H5 subtype of avian influenza A from seasonable influenza A and B viruses in humans, as the ongoing spread of H5N1 in animals across the United States raises concerns about a new pandemic as regular flu season looms. Currently, only CDC and US state and jurisdictional public health labs have access to CDC’s molecular test to detect the H5 strain of influenza A, which could lead to delays in diagnosis or treatment if we start to see transmission between humans. Decentralized testing capabilities at the point of care will be needed to ensure any spread between humans is detected and controlled quickly to avoid another pandemic, as well as to reduce the burden on centralized laboratories.  Last week, the endTB consortium announced the completion of the endTB-Q trial, the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant tuberculosis (pre-XDR-TB), with preliminary results demonstrating that a shorter, less toxic treatment strategy of four drugs achieved high cure rates overall, especially in those with non-severe cases of TB disease. Pre-XDR-TB has historically been treated with toxic regimens that last up to two years, are hard to tolerate, and are not very effective. This study tested a personalized medicine strategy, with disease severity and early treatment response used to decide between a six- or nine-month treatment regimen. The study included participants from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam.

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.