Breakthroughs Blog: Pandemic preparedness

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 Global Antibiotic Research & Development Partnership (GARDP) announced that a landmark clinical trial evaluating antibiotic combination treatment options for newborns with sepsis has been expanded to include hospitals across nine countries in Africa and Asia. Neonatal sepsis affects up to three million babies a year globally, a crisis that has been exacerbated by increasing numbers of antibiotic-resistant cases. The NeoSep1 trial is the first time that researchers will test whether new combinations of older antibiotics are safe and effective against treating newborns with sepsis compared to commonly used antibiotic regimens. The trial aims to provide critical data to help identify new treatments that could reduce the number of deaths and expand access to treatment.A new animal study from the US Centers for Disease Control and Prevention has found that H5N1 avian influenza is capable of spreading through the air, a finding that raises further concern about the ability of the virus, which continues its worrying spread among cattle populations, to cause a future pandemic. The researchers used a sample of the virus extracted from a dairy worker to infect a group of ferrets (the “gold standard” comparative animal population in flu research) that were then placed in close proximity to healthy ferrets and observed for three weeks. Three of that latter group contracted the virus without any direct physical contact with the infected ferrets, indicating that it can travel through the air, a finding that was confirmed with aerosol samples. The researchers emphasized that these findings underscore the need for continued surveillance of the ongoing outbreak.A team of researchers at the London School of Hygiene & Tropical Medicine (LSHTM) and the Indian Institutes of Science Education and Research have been awarded £550,000 by the Biotechnology and Biological Sciences Research Council to develop an effective vaccine against Campylobacter jejuni, the most common bacterial cause of infectious diarrhea, in poultry. A poultry vaccine could help reduce the rising incidence of C. jejuni human infections, which are common in young children, causing stunted growth, lifelong deficiencies, and even death. The LSHTM team has found a promising approach for developing new cost-effective vaccines, which will be furthered with the new funding.

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 group of researchers at the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia have discovered a way to tackle a longstanding challenge that has eluded researchers trying to develop a cure for HIV for decades. HIV can hide in certain white blood cells, creating a reservoir in the body that can later reactivate and evade targeting by the immune system and drugs. The researchers found a way to make the virus visible using mRNA technology, an achievement previously thought impossible and a step closer toward being able to fully clear it from the body. Further research is needed to determine whether revealing the virus is enough to make it vulnerable to the immune system or whether the technology will need to be combined with other therapies, suggesting this technology is still years away from reaching humans.Recently published research examining an understudied group of coronaviruses called merbecoviruses (the same group that includes MERS) found that while most merbecoviruses are unlikely to pose a direct threat to humans, one subgroup is only one small mutation away from being able to spill over into human populations and cause a major outbreak. This subgroup of viruses, called HKU5, has been found across Asia, Europe, Africa, and the Middle East, but its natural host is in Asia: the Japanese house bat. Previous research has already found one HKU5 virus that has been documented to jump across animal species. This study and its methods, specifically the use of artificial intelligence, could be used to improve further research and support the development of new vaccines and treatments. A group of scientists in Burkina Faso have successfully completed the first phase of a clinical trial testing the PfSPZ-LARC2 vaccine for Plasmodium falciparum malaria in youths between 6 and 19 years old. The vaccine, which was previously found to be safe and effective in adults, is unique and innovative because it uses genetically engineered parasites that cannot cause disease but are potent enough to generate immunity. In fact, the vaccine has demonstrated an ability to achieve higher efficacy at a lower dose and for a longer duration than existing vaccines for malaria. If proven effective in further trials, it could represent a significant game changer in malaria control efforts, reducing the burden on health care systems and increasing convenience for people in malaria-endemic countries, as well as travelers and military personnel.

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 research found that vaccinating infants for measles earlier could help close a crucial gap in protection in those early months of life and warrants further study, especially as measles cases surge globally, underscoring the need for new and innovative approaches. The systematic review looked at 34 journal articles with data from 8,000 babies under nine months old in low- and middle-income countries, finding that maternal measles antibody rates were highest at birth before decreasing rapidly, leaving infants with low antibody rates for months before their first recommended measles vaccine dose at 9-12 months, followed by a second at 15-18 months. An earlier first dose, achieved either by giving the first dose sooner or adding a third dose before the routine two-dose schedule, could help close that critical gap in immunity.Last week, Roche announced that it is launching a Phase 3 trial of its novel antibiotic candidate, zosurabalpin, in patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections, considered one of the most dangerous and deadly antibiotic-resistant pathogens and a priority for antibiotic development. The study, expected to start at the end of 2025 or early 2026, will compare the safety and efficacy of zosurabalpin with standard-of-care antibiotics in around 400 patients with CRAB infections at sites across Europe, North and South America, and Asia. Zosurabalpin was previously shown to demonstrate high efficacy in lab tests against human clinical CRAB isolates and in mice with lung and thigh infections caused by pan–drug-resistant A baumannii.The Coalition for Epidemic Preparedness (CEPI) announced last week that it has signed a new agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense to enable collaboration on several projects to boost global preparedness against future disease outbreaks, including through the development of medical countermeasures. The first project will support the development of a monoclonal antibody for the Nipah virus, a deadly zoonotic disease with no approved tools to defend against it. The department will transfer doses of a Nipah monoclonal antibody, which is currently undergoing Phase 1 testing in the United States, to CEPI for a Phase 1b/2a clinical trial in India and Bangladesh, two countries that see almost annual Nipah outbreaks. These trials aim to provide critical data that could enable access to the monoclonal antibody to protect vulnerable populations during an outbreak in Nipah-affected regions and the US joint forces in a potential emergency.