Breakthroughs Blog

A new real-world study found that a recently approved vaccine designed to reduce deadly meningitis in Africa is safe when used at scale. Neisseria meningitidis, or meningococcus, is a bacterium that is the leading cause of bacterial meningitis, a dangerous infection, in Africa. The African meningitis belt, which encompasses 26 countries in sub-Saharan Africa, has the highest rates of meningococcal disease, facing frequent epidemics. Since 2010, the introduction of a vaccine targeting one of the 12 bacterial strains has dramatically reduced meningitis in the region. The newer vaccine targets the five subtypes that are responsible for almost all epidemic meningitis in the region, and it was shown to be safe in a study analyzing data from more than 4.8 million people vaccinated during outbreak response campaigns in Nigeria and Niger in 2024. A research team has developed a breath-based test for diagnosing bacterial infections that showed promise in early studies in mice, which could eventually offer a non-invasive, portable, and quick alternative to the current toolbox of blood tests, imaging, cultures, and molecular diagnostics that can be slow, non-specific, and expensive. The researchers were inspired by a breath test for Helicobacter pylori, which works by a patient drinking a liquid containing traceable substances metabolized by H. pylori and then exhaling into a device that measures the components of their breath, indicating if an infection is present. Aiming to develop a breath-based test for a broader range of infections, the team developed a prototype using sugar and sugar alcohols tagged with a traceable form of carbon that bacteria metabolize but is not harmful to human cells, analyzing the breath using a simple technique. A team of researchers has designed a vaccine that turns mosquitoes into delivery vehicles to immunize bats against rabies and Nipah virus. Bats host a wide range of dangerous pathogens, which are increasingly spilling over into human and livestock populations. Researchers have previously tried testing experimental vaccines on captive bats, but the vaccines haven’t worked as effectively in the wild. Culling bat populations is another way to reduce disease transmission, but this can cause disruption to the ecosystem and can inadvertently heighten virus transmission by increasing human exposure. The new method involves an experimental vaccine that is delivered via the saliva of mosquitoes, which is transferred when bats eat the mosquitoes or the mosquitoes feed on the bats, directly targeting the natural reservoirs of these viruses to prevent spillover transmission. 

Fifteen years ago, the World Health Organization (WHO) issued formal guidance recommending the first WHO-endorsed rapid test for tuberculosis (TB), a landmark shift for a diagnostic landscape that had long relied on slow, labor-intensive microscopy and culture methods. For the first time, high-quality, same-day diagnosis could be possible for millions.Yet the promise of this breakthrough remains only partially realized. Despite major gains, access to WHO-recommended rapid tests has lagged, and many countries continue to depend on outdated diagnostic methods. In 2024, more than 8.3 million people were newly diagnosed with TB, but only around half of them were diagnosed with a WHO-recommended rapid diagnostic test as their initial test. Even more troubling, an estimated 2.7 million people around the world who develop TB remain undiagnosed and untreated.These persistent gaps point to a clear imperative: countries and global health partners must both accelerate access to existing rapid diagnostics and continue investing in the next generation of TB diagnostic tools designed for real-world settings. A new wave of innovative, accessible tools, including a recently recommended class of near point-of-care molecular tests and an emerging generation of digital and artificial-intelligence (AI)-powered screening tools, is now materializing, offering renewed opportunities to close the diagnostic gap for good.New class of near point-of-care diagnostic testsIn early 2026, WHO recommended a new class of near point-of-care tests, nucleic acid amplification tests (NPOC-NAATs), representing one the most significant advances in TB confirmation diagnosis in more than a decade. These molecular tests can detect TB in less than an hour using lightweight, battery-operated instruments that do not require specialized infrastructure for use or storage, making them easily portable. They can be used by health care workers with minimal training in primary health care clinics, mobile units, or community sites, bringing high-quality molecular testing closer to patients, dramatically shortening the time to diagnosis and treatment initiation, and reducing loss to follow-up.WHO now recommends NPOC-NAATs as the initial test for adults and adolescents with symptoms of pulmonary TB or a positive screening result, replacing smear microscopy, which involves the lengthier, more complex and resource-reliant process of collecting sputum (phlegm) samples and preparing them for examination under a microscope in a laboratory. Crucially, WHO also endorsed the use of tongue swabs when sputum samples cannot be collected, improving access for children, people living with HIV, and others who may struggle to produce sputum, who were underserved by previous options.A major milestone came in July 2025, when PlusLife’s MiniDock MTB assay became the first of this class approved by The Global Fund to Fight AIDS, Tuberculosis and Malaria’s Expert Review Panel for Diagnostics, making it eligible for procurement by Global Fund-supported programs. In early 2026, the Stop TB Partnership’s Global Drug Facility announced it would add the test to its portfolio at a low price, further accelerating global access.Additional NPOC-NAAT approvals are expected, which would increase the range of options for patients and drive down prices for governments and procurers, enabling countries to implement these technologies at scale. If widely adopted, NPOC-NAATs could dramatically expand access to high‑quality TB diagnostics, especially in rural and underserved areas where TB can go undetected.Growing number of digital and AI-powered screening toolsJust as a new class of molecular tests are reshaping TB diagnosis, a new generation of digital and AI-enabled devices are transforming TB screening, the essential first step that identifies potentially impacted people who need confirmatory testing. Over the past decade, rapid advances have enabled the development of innovative screening tools that are faster, more accessible, and better suited to the realities of remote and low-resource settings.Portable, battery-operated radiology devices are one tool that has emerged, with various commercial products starting to be rolled out at a larger scale in recent years. These devices can be brought directly to remote communities, improving screening access for hard-to-reach populations.In areas where radiology remains inaccessible, portable, point-of-care ultrasounds are another promising, low-cost solution for TB detection in low-resource settings. The Butterfly iQ portable ultrasound device is currently being evaluated in a large trial in sub-Saharan Africa, where it is being used alongside an AI algorithm that automatically classifies TB-related abnormalities in images captured by the device, helping health care workers faster and more accurately detect TB at the point of care.AI-powered computer-aided detection software has also advanced rapidly, with a growing range of commercial products in recent years. These tools automatically analyze and interpret chest X-rays to identify potential TB cases, expanding the reach and speed of screening programs. Since first recommending AI as a TB screening tool for adults in 2021, WHO has approved six software products for computer-aided detection.Digital stethoscopes are another AI-powered tool—they analyze lung sounds to rapidly screen for pulmonary TB, a solution that can be deployed in community and primary care settings, even by workers without specialized training. AI Diagnostics’ stethoscope and software platform captures high-resolution lung sound recordings and analyzes them using machine learning models, generating a screening result that allows health care workers to distinguish individuals at higher risk of TB. The device is approved in South Africa and is starting to be rolled out more widely.Looking forwardAs TB program budgets globally face growing financial pressures, it is more important than ever to phase out outdated technologies and rapidly scale up next-generation diagnostic tools engineered for broad accessibility. These innovations now emerging, including near point-of-care molecular tests and digital and AI-powered screening tools, represent a pivotal opportunity to close the longstanding diagnostic gap and strengthen TB care pathways.Alongside these efforts, sustained investment in the robust pipeline of new TB diagnostics is also essential to driving continued progress, particularly for solutions that remain understudied: diagnostics tailored for children and other vulnerable populations and treatment monitoring tools to help tailor regimens for people at risk of poor outcomes.With deliberate action and continued innovation, the global community can deliver a better diagnostic ecosystem that meets people where they are and ensures that no one with TB goes undiagnosed or untreated.

2026 marks 20 years since Congress passed the Pandemic and All-Hazards Preparedness Act (PAHPA)—now titled the Protecting Americans from All Hazards Preparedness Act—landmark legislation to strengthen the nation’s public health emergency preparedness and response capabilities. PAHPA was reauthorized in 2013 and 2019, but its authorization lapsed at the end of 2023, leaving many authorities dependent on temporary extensions advanced through appropriations bills and continuing resolutions (CRs). As a result, key policies and structures guiding the US government’s pandemic playbook predate a generation-defining pandemic, underscoring the urgency of reauthorizing this legislation to integrate lessons learned and ensure the United States is better equipped against current and future threats.Efforts to reauthorize PAHPA have proved challenging in a post-COVID-19 political environment. The Senate advanced in mid-2023 a largely clean PAHPA bill with some additional provisions addressing drug pricing, drug shortages, and related issues. However, differences between House proposals stalled further progress, ultimately leading House Republicans and Democrats to introduce separate proposals. A potential breakthrough emerged in late 2024, when a bipartisan health care package containing PAHPA gained traction as part of an end-of-year continuing resolution. The broader health package ultimately fell apart, leaving PAHPA reauthorization unresolved.PAHPA originally amended the Public Health Service Act to establish two cornerstone institutions: the Administration for Strategic Preparedness and Response (ASPR) to lead the nation’s public health emergency response, and under it—and most notably for global health R&D—the Biomedical Advanced Research and Development Authority (BARDA) to accelerate the development of medical countermeasures (MCMs) against emerging infectious diseases (EIDs), antimicrobial resistance (AMR), and pandemic influenza. Together, these entities transformed how the United States invests in, coordinates, and implements medical preparedness and response capabilities. Reauthorization now offers a critical opportunity to renew and strengthen these authorities for future threats.Reauthorization is not simply procedural—it is essential to restoring and enhancing the authorities that enable BARDA and partners to advance lifesaving MCMs. Done thoughtfully, PAHPA renewal could reinforce accountability, transparency, and coordination while safeguarding the United States’ position as a global biomedical innovation leader. Stable, modernized authorities ensure scientists and innovators have the support needed to develop and scale up next-generation technologies that protect Americans and strengthen health security worldwide.GHTC’s vision for PAHPAPrompted by a request for information shared by Representatives Neal Dunn (R-FL) and Lori Trahan (D-MA), GHTC has identified clear opportunities through reauthorization to maintain the strong momentum PAHPA has driven and build an even more proactive, innovative preparedness architecture that keeps us one step ahead of emerging pathogens. From reactive to readyBARDA and external partners estimate that $775 million is needed to successfully advance an EID MCM portfolio at the agency. While a dedicated Influenza and Emerging Infectious Disease (IEID) Division exists, predictable, dedicated funding for this work does not. Historically, investments for EID MCM development have come primarily through emergency supplemental funding bills passed in the wake of public health crises like Ebola, Zika, and COVID-19, reinforcing a reactive rather than proactive posture. To address this gap in preparedness, PAHPA should establish dedicated funding for BARDA's IEID Division to ensure sustainability and readiness.To reinforce BARDA’s critical efforts against AMR, Congress should advance complementary legislation—including the newly reintroduced Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act and the Saving Us from Pandemic Era Resistance by Building a Unified Global Strategy Act (introduced in the 118th Congress)—to strengthen the pipeline of new tools for antimicrobial-resistant pathogens and support pull incentives that accelerate AMR R&D.MRNA is a critical platform technology for advancing next-generation vaccines and therapeutics. Sustained investment in mRNA research will be critical to maintaining US scientific leadership. Congress should explicitly authorize BARDA to invest in mRNA technology and prioritize its investment via report language directives to ensure the United States sustains the necessary capabilities for a rapid response. Protect the gainsWith the current BARDA Strategic Plan set to end in 2026, a new plan is needed to articulate its goals for the next five years, incorporating lessons learned from the last five. To strengthen the effectiveness and credibility of this plan and ensure it is informed by the best available science and aligned with real-world preparedness needs, BARDA should look to scientific experts, product developers, and other external stakeholders to inform the 2027-2031 strategy via an open, consultative process. Congress should direct BARDA to complete this plan.PAHPA should also mandate BARDA to regularly and publicly report on its MCM research and product-level investments to ensure consistent reporting, regardless of future leadership changes at the department. BARDA's improved efforts on reporting have already been instrumental in a host of ways, so codifying this practice is essential to strengthening transparency and accountability.In an effort to further support national preparedness, BARDA should be directed to run a feasibility study on the creation of a loan authority program to better enable the agency to finance large-scale, capital-intensive projects such as innovative biomanufacturing facilities like those for microneedle patch vaccines. Too often, constrained health workforce and laboratory capacity can hinder the deployment of MCMs in low-resource settings, both in the United States and globally. To ensure this issue does not persist, PAHPA should direct ASPR to study barriers to MCM deployment in low-resource communities and authorize national and global engagement activities during MCM development to ensure products are usable and effective in these settings. Keep what worksAn authority established by the 21st Century Cures Act, the Medical Countermeasure Innovation Partnership, which uses venture-capital-style investment from BARDA to advance MCMs, will expire at the end of fiscal year 2028 under current PAHPA legislation. Given the program’s successful track record—advancing at least eight promising innovations—Congress should eliminate the sunset clause to preserve this productive mechanism. BARDA’s commitment to combatting AMR remains more pertinent than ever. Bacterial AMR was directly responsible for an estimated 1.14 million deaths in 2021 and associated with a total of 4.71 million deaths. Without action, annual deaths attributable to AMR could increase by almost 70 percent, totaling 10 million by 2050, with significant deaths among children and newborns. The pipeline of new antimicrobials and other tools remains insufficient. The critical support BARDA has provided for the development of AMR products must be maintained to meet this escalating threat.See the formal letter that GHTC submitted to Reps. Dunn and Trahan detailing each of these recommendations in full here.The future of R&D preparedness Reauthorizing and modernizing PAHPA is not just about restoring an expired statute; it is about defining the kind of biosecurity leader the United States intends to be in the decades ahead. PAHPA occupies a unique position in the health security landscape. It provides not only the authority to respond effectively during public health emergencies, but also the framework to make proactive, forward-looking investments that keep us one step ahead of emerging biological threats. There is growing bipartisan recognition of the urgency behind many of PAHPA’s core provisions, particularly as the global health and biomedical innovation landscape has shifted dramatically in recent years. Through thoughtful policy refinements, Congress can help shape a future that catalyzes more inclusive innovation, builds stronger public-private partnerships, and ensures the benefits of MCM development are fully realized, saving more lives in the United States and around the world.  At a moment when the cost of being unprepared is painfully clear, the choices made around PAHPA reauthorization will reverberate far beyond US borders and for years to come, helping determine how the world anticipates, confronts, and ultimately mitigates the next generation of health emergencies.

Newly shared results from a Phase 3 clinical trial found that a single-dose dengue vaccine was highly effective at preventing severe dengue, as the mosquito-borne disease continues to spread into new areas around the world. The vaccine, developed by the Butantan Institute in Brazil, was recently approved in Brazil for use in people aged 12 to 49 years old. The new trial found that among thousands of participants aged 2 to 59 years old, the vaccine was effective at preventing symptomatic dengue but especially effective—80.5 percent— at preventing hospitalization for at least five years. The World Health Organization (WHO) has shared new guidance highlighting critical targets for new antibiotics, as the global threat of antimicrobial resistance (AMR) continues to grow and outpace the development of new and innovative antimicrobials. The three areas outlined are the development of new drugs to fight Gram-negative bacteria that cause serious infections that are especially difficult to fight; new drugs for patients with serious infections that can no longer be treated with vancomycin, a powerful last-resort antibiotic; and new treatments for bacterial meningitis, which is getting harder to treat due to growing antibiotic resistance. While the research and development of a new antibiotics can be difficult, expensive, and not as profitable as other products, WHO aims to highlight key areas for investors and developers to focus their efforts to grow the pipeline of new, urgently needed tools. Last week, the Sabin Vaccine Institute announced that it has completed enrollment in six Phase 2 clinical trials for its Marburg and Sudan Ebolavirus vaccines in Kenya, Uganda, and the United States, as increasing outbreaks of both viruses in recent years have highlighted the urgent need for vaccines. There are currently no licensed vaccines for protection against the highly contagious, life-threatening diseases caused by these viruses. The Marburg vaccine has also been evaluated during recent outbreaks in Rwanda in Ethiopia. Both candidates have so far demonstrated strong safety and efficacy profiles. The Sabin Vaccine Institute has also begun planning larger Phase 3 trials for each of the vaccines.