Breakthroughs Blog: BARDA

Last week, French biopharmaceutical company Osivax announced that it received a $19.5 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to further develop its broad-spectrum influenza A candidate vaccine for pandemic and seasonal flu preparedness. The vaccine is designed to target a part of the virus that is highly conserved and less likely to mutate, hopefully offering a broader, more universal immune response, and it has demonstrated promising results in early clinical trials. BARDA’s funding will support ongoing clinical development and large-scale trial and manufacturing preparation, with potential options for future funding to support Phase 2b and scale-up activities. A team of researchers at the University of Nottingham successfully produced antibodies that kill the parasite that causes Chagas disease, an important step toward the development of a much-needed vaccine. Chagas is a serious neglected tropical disease, which causes 56,000 cases and 12,000 deaths every year. The researchers developed antibodies targeting two key proteins in the parasite that were found to be extremely effective at neutralizing the parasite in a crucial developmental phase when it’s capable of infection, which is key for vaccine development.   A University of Maryland research team developed an artificial intelligence (AI) tool that can quickly scan electronic medical records to identify high-risk patients who may be infected with H5N1 avian flu, as this year’s outbreak highlights the need for more robust screening interventions to ensure infections are not going undetected. The researchers used their generative AI large-language model to analyze the records of more than 13,000 adults who had visited the emergency department in Maryland in 2024 for acute respiratory illness and common H5N1 symptoms. With less than half an hour of human input, the model found 76 records that mentioned a lifestyle risk factor for H5N1, 14 of which were confirmed to have a recent exposure to animals that transmit H5N1. The tool highlights the shortcomings of the response to the latest outbreak and offers a potential new tool to help improve surveillance and testing in future outbreaks of H5N1 and other infectious diseases.

On Thursday, Senate appropriators advanced out of committee a fiscal year (FY) 2026 spending bill for the Department of Health and Human Services (HHS) that rejects billions in health spending cuts proposed by the Trump Administration and protects programs vital to global health innovation.The bill increases or flat-funds global health research-relevant agencies, including the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), and slightly reduces funding for the US Centers for Disease Control and Prevention (CDC) compared to FY25 enacted—an outcome that is in stark contrast to the President’s Budget Request (PBR), which proposed deep cuts across all three. Funding at this level will enable these agencies to continue to advance medical breakthroughs and operate programs that deliver better health outcomes for people around the world and fortify our defenses against disease threats.Funding highlightsThe legislation allocates $48.7 billion in funding for NIH, which is a $400 million (.8 percent) increase compared to FY25 enacted and nearly $22.2 billion (77 percent) above the PBR, and $1.015 billion for BARDA, which represents level funding from FY25 but $361 million (55 percent) more than the White House request. While the legislation unfortunately cuts funding for CDC by $72 million, or 1 percent, this allocation is $4.8 billion or 112 percent greater than the President’s request.While advocates expected the Senate to reject the steep cuts proposed by the Trump Administration, many still anticipated significant reductions. It is therefore both welcome and surprising that Senate appropriators advanced a spending package that maintains strong funding for many programs the President aimed to slash or eliminate.Beyond topline funding for agencies, the bill and accompanying report also diverge from the PBR in other crucial ways. While the President proposed eliminating the CDC Global Health Center (GHC), this spending bill keeps the center intact, maintaining level funding from FY25. The bill also maintains flat funding for the NIH Fogarty International Center—which supports global health research partnerships and training—and provides a 0.5 percent increase to the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). This stands in sharp contrast to the White House’s proposal to eliminate Fogarty entirely and cut NIAID’s budget by 58 percent. Additionally, it provides level funding to the Advanced Research Projects Agency for Health (ARPA-H), a new agency established under the Biden Administration to support high-risk, high-potential health research, rejecting the President’s proposal to reduce its funding by $555 million.Beyond  funding numbers, the bill’s accompanying report includes welcome directives affirming the Senate’s support for research activities critical to global health, including across health areas like neglected tropical diseases, malaria, tuberculosis, emerging infectious diseases, antimicrobial resistance (AMR), and more, and underscores the importance of international health research partnerships and training programs supported by the Fogarty International Center and global health activities undertaken by CDC GHC and NCEZID.  Taken together, the funding and directives can be viewed as a strong rebuke of the president’s efforts to downsize and dismantle US global health efforts and a strong affirmation of the Senate’s support for programs that save and improve lives around the world and protect Americans from disease threats. The report also dictates stricter reporting requirements to Congress for HHS, indicating bipartisan concern by lawmakers as to whether the agency is dispersing funding as directed and making scientifically-drive decisions.The report also conveys Senate appropriators’ desire to see BARDA devote robust funding to developing countermeasures against emerging infectious diseases, AMR, and pandemic influenza, and directs BARDA to spend no less than $10 million on advancing countermeasures against “Disease X,” which is a term to denote priority viral pathogens that could cause the next pandemic. Despite an overall positive picture, the bill does include some decreases to subaccounts relevant to global health, including an 80 percent cut to  the CDC-wide Infectious Disease Rapid Response Fund, which was a fund originally created to provide flexible funds for the agency to rapidly respond to pandemic and epidemic threats. See the chart below for a more detailed comparison of funding in the Senate bill and percent changes compared to FY25 enacted and the PBR.What comes nextThe bill’s passage out of committee is just an initial step in a lengthy political process. It will next go to the full Senate for a vote, the House of Representatives will need to advance its parallel bill, and then the two bills will need to be conferenced to work out their differences before going back to both chambers for a vote and then to the President for signature.It is anticipated that the House will propose lower spending levels for health programs than the Senate, so these numbers are a likely high watermark where negotiations begin between the two chambers. Nonetheless, if one reads the House’s spending bill on global health as a tea leaf of what’s to come, it’s unlikely the House will cut as deep as the President wishes , so if the two chambers can reach a compromise and pass a budget, we could see funding levels land somewhere below the Senate but still substantially above the PBR. In the House bill, we are likely to see stronger relative numbers for NIH over CDC, given heightened criticism for the latter agency among Republican lawmakers.For many advocates, this bill is welcome news that Congress is reasserting its power of the purse in opposition to the president, yet significant concerns remain. Will the two chambers actually reach a promising compromise? And even if Congress appropriates strong funding for FY26, given all the recent moves by the Administration to rescind, halt, or slow the disbursement of federal spending, will this money actually reach researchers and health implementers to deliver impact? While we can’t predict for certain, GHTC and other advocates will continue to keep a close watch on what’s to come and activate where we can in order to protect vital funding for global health and medical research. 

Over the past few months, the US administration has made sweeping changes at the Department of Health and Human Services (HHS), the backbone of America’s public health and health research infrastructure, which contains the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA). Together, NIH, CDC, and BARDA, in conjunction with other agencies across the government, support the development of health technologies that save and improve lives in the United States and around the world, including a key role in combatting emerging infectious diseases and longstanding global health challenges like HIV/AIDS.   As the United States’ lead agency for medical research, NIH has long been at the forefront of scientific discovery, pushing forward innovations in health technology across a range of health areas. In compliment, BARDA supports the advanced development of medical countermeasures against diseases with pandemic potential to shore up the nation’s public health security, and CDC, alongside tracking the spread of diseases and other health threats, supports the development of new diagnostic, prevention, and surveillance technologies and evaluates the effectiveness of existing tools to inform future research and development (R&D) needs. Far-reaching cuts to HHS’s workforce and infrastructure and the terminations of thousands of research grants—with further budget reductions proposed—threaten to reverse decades of scientific progress, shrink the pipeline of next-generation health technologies, weaken the country’s biomedical workforce and industry, and make Americans and people around the world more vulnerable to longstanding and emerging health threats.  Widespread job losses and restructuring jeopardize key R&D functionsThe US administration has overseen the dismissal or abrupt exits of up to 20,000 federal employees across HHS—amounting to 25 percent of the workforce. Thirteen hundred jobs were eliminated at NIH and around 2,400 at CDC (while some jobs have since been restored, the administration’s pivots have made it hard to track the scale and permanence of these changes), including the removal of directors and gutting of divisions focused on infectious disease and global health partnerships. The departure of these staff—from seasoned leaders to young recruits—represents an immense loss of expertise and promise and could lead to severe disruptions in critical research and surveillance efforts.Additionally, HHS has also canceled thousands of research grants over the past few months—estimates of the value of terminated funding at NIH alone range from $1.8 to $2.7 billion (more than 1,000 grants terminated and 1,000 additional projects that had funding delayed) and billions more from CDC and BARDA, with research on COVID-19 and other emerging infectious diseases and HIV/AIDS particularly impacted. Moreover, a new NIH policy halting foreign subawards could upend international research collaborations and put thousands of additional grants at risk of termination, while a policy to cap NIH indirect research costs, which has remained blocked in the courts, could further erode available funding to support researchers.Beyond these initial layoffs and cuts, the administration is also proposing a restructuring effort and federal budget for fiscal year 2026 that would reduce funding for NIH, CDC, and BARDA by 43, 53, and 36 percent respectively and implement a new primary focus on chronic disease at HHS, shuttering key centers carrying out infectious disease research and forging global partnerships, including the NIH Fogarty International Center and CDC’s Global Health Center and National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention.While thoughtful and thorough reforms could serve to improve these agencies’ ability to carry out critical work and ensure American taxpayer money is well spent, the rapid pace and far-reaching scale of these cuts and changes (which have seen pushback in the courts) has aroused concern among many across academia, industry, and the medical research sector who fear long-term health and economic consequences and the risk of a US scientific workforce “brain drain,” as researchers leave the field or country altogether. Terminated research makes Americans more vulnerable to emerging health threatsFrom avian influenza to COVID-19, Ebola, and mpox, emerging health threats pose a growing risk to Americans in our increasingly interconnected world. We know all too well the significant toll of pandemics, both in terms of lives lost and health care spending and economic disruptions.NIH, CDC, and BARDA have historically played a crucial role in ensuring that Americans have the technologies to protect us against disease threats wherever they arise. The research that led to the development of the mRNA vaccines for COVID-19 and rapid diagnostic tests and the world’s first vaccine and treatments for Ebola were all supported by one or multiple of these agencies.Unfortunately, research on COVID-19 and other emerging threats have been among those areas most heavily impacted by recent grant terminations, caught in the crosshairs of various efforts to claw back COVID-19 funding; curtail funding for mRNA, gain-of-function, and vaccine research; zero out funding for specific universities; and prioritize chronic disease research.For example, at NIH, an initiative founded in 2022 to support the development of antivirals against a range of pandemic threats, including the viruses that cause Ebola, Zika, and measles, was defunded. Other NIH-funded projects to develop pan-coronavirus vaccines that could protect against COVID-19, MERS, SARS, and other yet-to-emerge coronaviruses, as well as drugs targeting a range of RNA viruses, including coronaviruses, avian influenza, and measles, were also cut.At CDC, $11.4 billion in funding allocated for the COVID-19 response was pulled back, including funding that was supporting essential surveillance and preparedness activities for COVID-19 and other emerging health threats. Meanwhile, at BARDA, grants supporting the late-stage development of mRNA vaccines for avian influenza were terminated over concerns about the safety of mRNA technology, despite scientific consensus that mRNA vaccines are safe and saved millions of lives during the COVID-19 pandemic.If enacted, the proposed HHS restructuring and president’s budget proposal would also eliminate key functions across NIH and CDC that serve as our first line of defense against pandemic threats. These include institutes and centers, like the NIH Fogarty International Center and CDC Global Health Center, that provide critical training, forge international partnerships, and monitor and respond to threats abroad.   If a new outbreak were to start (or if one of the several ongoing ones suddenly worsened) tomorrow or next month, the precious expertise, resources, and technologies in the pipeline that are now being lost or rolled back would mean Americans would be less safe and less prepared. In fact, the very ability to swiftly identify a new outbreak is now in question. Research terminations set back progress in the fight against HIV/AIDS and other longstanding global health challengesHIV has led to the deaths of more than 700,000 people in the United States since 1981, with 1.2 million Americans now living with HIV. NIH and CDC have played a crucial role in developing technologies and supporting programs that have reduced the number of new infections and enabled Americans and people around the world living with HIV to live longer and healthier lives.NIH has long been a global leader in HIV R&D, working with partners to isolate the virus for the first time and discovering a new class of antiviral drugs that helped turned HIV into a manageable chronic condition. HIV research supported by NIH has also led to technologies for other diseases and health conditions that affect millions of Americans, including cancer, heart failure, and even COVID-19. But efforts to drastically reduce funding for infectious disease research, including HIV research, at the agency could slow the discovery of future health breakthroughs.NIH has already terminated at least $759 million in grants involving HIV research, with many caught up in attempts to realign US investments away from diversity, equity, and inclusion efforts; zero out federal funding for several universities; crack down on funds going to foreign sub-awardees; and cut all foreign aid dollars for South Africa.  The latter two policies targeting research done outside of the United States are of particular concern for HIV R&D. While HIV continues to affect many Americans, to ensure new technologies are broadly effective, it is crucial to conduct research in diverse populations of people living with or at risk of HIV, including populations outside the United States—especially in South Africa, which remains the epicenter of the pandemic. The executive order ending US aid to South Africa has already threatened the continuation of at least 24 HIV trials being carried out there, including those advancing some of the most promising new tools. (The impact of these two policies also goes far beyond HIV/AIDS, with basic and clinical research on other longstanding global health challenges like tuberculosis and malaria also disrupted).NIH supports four global HIV clinical trial networks, which facilitate cross-sector and international partnerships furthering HIV R&D, all of which have seen their ongoing research or functions hampered in some way in the last few months by terminations and this collection of policies. They are now having to grapple with their future; one network has already scaled back ongoing studies, declined new research opportunities, laid off employees, and canceled at least six scheduled trials.NIH also notified two major consortia working on developing an HIV vaccine that it will not renew funding next year. While new long-acting HIV prevention tools represent major breakthroughs, most experts agree that a traditional, immunizing vaccine is still needed to sustainably end HIV/AIDS as a global health challenge. The consortia’s work has had tremendous success, furthering what are widely considered the most innovative, experimental vaccine candidates into clinical trials.  CDC has also played a complementary role in HIV efforts, leading surveillance and supporting research to help improve prevention and treatment efforts in the United States and globally. It is also a key implementing agency of the President’s Emergency Plan for AIDS Relief, or PEPFAR. Proposed budget cuts and restructuring at CDC would curtail domestic HIV prevention and surveillance activities, as well as eliminate the agency’s Global Health Center and, with it, a specific funding line for global HIV and TB activities (though the agency will likely continue to implement certain PEPFAR activities), undermining the ability of public health officials to track new infections and ensure patients can start treatment in a timely manner. They would likewise dismantle the NIH Fogarty International Center and, with it, programs that have long played a key role in training the next generation of HIV researchers.These changes threaten to set us back in the decades-long effort to develop a vaccine and other game-changing technologies to address HIV/AIDS, which were gathering momentum recently, with promising vaccine clinical trial results and the recent approval by the US Food and Drug Administration of an injectable HIV prevention drug (developed using evidence from NIH-funded research) that provides long-term protection—the next best thing from a vaccine. Delays and suspensions of ongoing research, as well as disrupted surveillance and services, could not only stall the development of the next generation of technologies, but also potentially lead to a resurgence of HIV in the United States and around the world.The bottom lineInvestments in global health R&D, including investments in emerging infectious disease and HIV/AIDS R&D, at NIH, CDC, BARDA, and other US agencies have demonstrated a huge return on investment, delivering 67 new technologies approved since 1999 for neglected and non-COVID emerging infectious diseases. Additionally, between 2007 and 2022, at least 86 percent of all funding that the US government directed to global health R&D was reinvested in American companies and institutions. This investment has created an estimated 600,000 new American jobs, spurred $104 billion in direct economic activity, and yielded scientific knowledge to inspire further innovations, which will ultimately generate $255 billion in long-term benefits to the American economy.  As the global heavyweight in biomedical R&D, NIH investments alone have generated hundreds of thousands of jobs and billions in new economic activity in every state (including the most rural ones), bolstering the American universities, research institutes, and businesses that make up the biomedical sector. And it pays off: every $1 received from NIH generates $2.46 on average in increased economic activity. In fact, we’re already beginning to see the dramatic economic fallout of this pullback in investment. These past investments have made America a global leader in biomedical innovation. As other countries start to pursue American researchers who have lost jobs and funding and China makes major investments and advances in life sciences R&D, for the first time surpassing the United States in drug clinical trials in 2024, America could fall behind. Investing in biomedical research is a tide that raises all boats and benefits cross-cutting health areas. In an era of great scientific opportunity but increased risks, this is the time to invest more and shore up the critical work at HHS agencies to boost the economy, America’s leadership on the world stage, and our ability to protect Americans and people around the world from an ever-increasing roster of longstanding and new health threats. 

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. Last week, the US Department of Health and Human Services announced a $500 million investment into a vaccine project under a new initiative called Generation Gold Standard, which aims to advance universal influenza vaccines, hoping to get a vaccine into clinical trials next year and approved by 2029. The initiative, funding for which will come from the Biomedical Advanced Research and Development Authority, seems to be replacing Project NextGen, which had previously funded research into potential COVID-19 vaccines and treatments. Some experts and officials have expressed surprise at the direction of the initiative and the size of the investment.Scientists have discovered that a device used to diagnose bacterial meningitis in blood can also measure it in cerebrospinal fluid, helping speed accurate diagnosis and treatment of the illness, which is the most dangerous form of meningitis and a significant global health threat. The device has demonstrated high sensitivity in multiple cohorts of patients and it’s also affordable and delivers results within a half hour after spinal tap. The test was developed at an impressive speed, now available to patients within just a year of its discovery.Newly shared results from a clinical trial from the National Cancer Institute seem to confirm that a single dose of the vaccine used to prevent human papillomavirus (HPV) virus infection is just as effective as two, a finding that could transform efforts to reach the millions of children globally who are not getting vaccinated according to recommendations. Expanding HPV vaccination will also help reduce the global burden of cervical cancer deaths and deaths from other HPV cancers. While two doses are currently recommended, reducing the required dosage could make dissemination much easier and cheaper for many countries.