Breakthroughs Blog: BARDA

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.

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 Sabin Vaccine Institute has launched a multi-site Phase 2 clinical trial, supported by the Biomedical Advanced Research and Development Authority, in the United States to test its Marburg vaccine candidate, as outbreaks of the virus, for which there is no approved vaccine, grow in frequency. This trial builds on previous Phase 2 testing in Kenya and Uganda, as well as an open-label Phase 2 trial in Rwanda during the country’s outbreak last year. These trials in the African regions where Marburg and other similar viruses are most common or endemic are key to ensuring the vaccine is effective in the populations currently facing the highest risk of outbreaks. In addition, this new trial in the United States provides key safety and immune response data in non-endemic populations, helping prepare us for the possibility of outbreaks outside of the virus's typical range.Researchers have discovered a small antibody fragment that can block fertilization by targeting a key protein on the egg's surface, potentially paving the way for a nonhormonal contraceptive method. The fragment was found to be effective in mice, and it could potentially have fewer side effects due to its small size. Currently available hormonal contraceptive methods can cause side effects, like mood changes, headaches, or increased risk of blood clots, leading researchers to look for nonhormonal options for people who do not want to or cannot use hormonal methods. The researchers will next develop a similar antibody for human targets and test it in IVF experiments.The Drugs for Neglected Diseases initiative (DNDi) and partners initiated Phase 2 clinical trials in Malawi and Tanzania testing a new, easier-to-administer, and patient-friendly formulation of flucytosine, a medicine used to treat cryptococcal meningitis, which is a major health threat to people with weakened immune systems, including those with advanced HIV disease. Currently, flucytosine can be difficult to administer in resource-limited settings, and many countries face limited supply. As a result, access to timely treatment is limited in Africa, where the disease kills up to 70 percent of those who get it. The new formulation reduces dosing frequency from four times a day to just twice daily, is easier to take with water or through a nasogastric tube, and is suitable for outpatient self-administration.

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, scientists in Rwanda and partners from the World Health Organization launched the world’s first clinical trial testing a treatment for the deadly Marburg virus amid the ongoing outbreak in the country. There are currently no approved treatments or vaccines against Marburg virus, although a clinical trial of Sabin Vaccine Institute’s investigational vaccine is currently underway in Rwanda. The new trial will investigate the safety and efficacy of remdesivir and the monoclonal antibody MBP091, developed by Mapp Biopharmaceutical with support from the Biomedical Advanced Research and Development Authority.  At the recent G7 Joint Finance and Health Ministers’ Meeting, the Italian government announced a $21 million commitment over the next three years to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to accelerate the development of innovative products to prevent, diagnose, and treat drug-resistant bacterial infections. AMR is a growing public health crisis, particularly in low- and middle-income countries, and there is an urgent need for international collaboration and investment to revitalize an inadequate clinical pipeline and ensure new antimicrobials, antimicrobial alternatives, and diagnostics are available for patients worldwide.Valneva and LimmaTech announced last week that their Shigella4V (S4V) vaccine has been awarded Fast Track designation by the US Food and Drug Administration. There are no approved vaccines for the Shigella bacteria, which causes shigellosis, the second leading cause of fatal diarrheal disease globally, particularly among children in low- and middle-income countries. S4V is the world’s most clinically advanced tetravalent bioconjugate vaccine for shigellosis. This designation will enable accelerated clinical development and review of the vaccine, which will be investigated in two Phase 2 trials that are expected to begin before the end of 2024.