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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. 

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to a new and simpler treatment for sleeping sickness, a serious vector-borne disease found in rural sub-Saharan Africa, for which the current treatment can be long and challenging. The Drugs for Neglected Diseases initiative (DNDi) and Sanofi co-developed a single-dose oral treatment, acoziborole, for both early- and advanced-stage infections in people 12 and older, which was found to be highly effective in a pivotal clinical trial. The endorsement will support further regulatory approval and rollout. Sanofi has pledged to donate doses to the World Health Organization, helping improve access to the new drug in the places where it’s most needed. Another study underway is testing the drug in children between 1 and 14 years old. The Global Antibiotic Research and Development Partnership (GARDP) recently announced that it has acquired all data and licensing rights for apramycin, an antibiotic introduced in the early 1980s to treat serious bacterial infections in animals, to evaluate its potential as a promising antibiotic against drug-resistant infections in humans. The drug has shown potential for human use in preclinical trials, but early-stage development stalled after the company developing it closed. The organization has planned a Phase 1 study set for 2027 to assess safety and pharmacokinetics. Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced that it’s awarding $1.2 million to Harvard University’s Andrew G. Myers Research Group to develop novel antibiotics for multidrug-resistant bacteria like Escherichia coli and Klebsiella pneumoniae, which cause serious infections around the world. Despite their significant global threat, the pipeline for novel antibiotics against these priority pathogens is lacking. The Harvard team will use the funding to further preclinical development of a new class of antibiotics that target a critical part of multidrug-resistant bacterial pathogens that plays a key role in the pathogens’ ability to cause infection and evolve drug resistance, which the researchers hope will be able to overcome drug-resistant infections without contributing to the emergence of broader cross-resistance.  

Women’s health remains one of the most underfunded and under-explored areas in health research, despite its profound importance to the lives of women and health outcomes across populations. Today, only about 5 percent of health research and development (R&D) funding worldwide is dedicated to women’s health, and less than one percent of that share supports non-cancer-related conditions, leaving vast gaps in our understanding of conditions that disproportionately or uniquely affect women. These gaps persist globally, including within the United States, where the National Institutes of Health (NIH) plays a central role in shaping biomedical research priorities. While these disparities remain clear today, meaningful progress has been made in women’s health—particularly in expanding women’s inclusion in research and establishing foundational policies that prioritize sex and gender in science. This March, in recognition of Women’s History Month, we look back at key milestones at NIH that have advanced women’s health research. These achievements not only highlight how far the field has come but also help guide where we need to go next. For decades, women were systematically excluded from clinical research, leading to critical gaps in the knowledge needed to adequately understand, diagnose, and treat diseases and other health challenges faced by women. Women’s symptoms were misunderstood, their risks underestimated, and their health needs too often treated as a secondary, niche issue rather than a scientific imperative.  The women’s rights movement of the 1960s ignited a parallel women’s health movement that forced policymakers and scientists to confront systemic disparities. A pivotal turning point came in 1983, when the Public Health Service Task Force on Women’s Health Issues—established by Assistant Secretary for Health Edward Brandt Jr.—became the first federal initiative focused on increasing women’s inclusion in NIH-funded clinical trials. The Congressional Caucus for Women’s Issues echoed that call to action. These were not symbolic gestures, but structural interventions that began reshaping the research enterprise. By 1990, sustained advocacy led to a major advancement: the creation of the NIH Office of Research on Women’s Health (ORWH). For the first time, NIH had a dedicated mechanism and leadership to strengthen, coordinate, and champion women’s health research across the agency. Congress codified and strengthened this progress with the 1993 NIH Revitalization Act, which formally established the ORWH into law and, importantly, mandated that women and minorities be included in all NIH-funded clinical research. The latter change was spurred by a group of female members of Congress who recognized deficiencies in NIH’s prior 1986 internal guidelines that urged but did not require that women be included. These landmark policy changes helped transform women’s health from a peripheral cause into a core component of biomedical science, propelling meaningful scientific progress. With the ORWH fully in force, NIH launched additional efforts to improve women’s health research, including the Specialized Centers of Research on Sex Differences. This initiative aimed to accelerate the translation of discoveries about sex differences from basic science into clinical applications, bridging gaps between laboratory research and women’s clinical care. In 2018, the effort evolved into the Specialized Centers of Research Excellence on Sex Difference—a network of research centers dedicated to advancing translational research on the role of sex differences in the health of women. The 2006 NIH Reform Act, further strengthened ORWH by elevating it into the NIH Office of the Director. This shift gave ORWH greater authority to coordinate across institutes and centers, influence research priorities, and ensure women’s health considerations were integrated at the highest levels of decision-making and across the entire R&D continuum. After two decades of building a scientific and policy foundation for better inclusion, NIH took another pivotal step that reshaped the research enterprise: the NIH Policy on Sex as a Biological Variable (SABV). Implemented in 2016, the policy required researchers to factor sex into the design, analysis, and reporting of basic, preclinical, and clinical studies. For years, basic science relied heavily on male cells and male animal models, embedding blind spots at the earliest stages of discovery. By requiring scientists to examine how sex influences health and disease from the outset, NIH strengthened the rigor, reproducibility, and translational value of federally funded research. The policy helps ensure that differences in disease progression, drug metabolism, immune response, and treatment efficacy are identified early before they become costly failures or missed opportunities in product development. By institutionalizing sex-informed research design, SABV signaled a clear shift in practice. Inclusion is not just about who participates in research, but also about how science is conducted.  In parallel, Congress also passed the 2016 21st Century Cure Act that affirmed and enhanced compliance requirements around SABV and required that people of all ages be included in clinical research unless valid scientific reasons existed for exclusion. The policy also established a task force to advance recommendations, knowledge, and guidance around the safe inclusion of pregnant and lactating individuals in clinical trials.  In 2019, NIH published its first comprehensive strategy to advance the health of women, which outlined the agency’s activities and objectives from 2019 through 2023. Though an updated strategy has since been released, this first plan marked an important first step in translating ORWH’s mission into a unified NIH vision with a structured path forward. With input from technical experts and civil society, NIH published its second women’s health strategy. The current plan prioritizes advancing research on women’s health disparities and underscores the importance of basic and translational research in biomedical discovery and innovation. While it addresses other issues, including actions related to the inclusion of women and girls in clinical trials, much of its focus is on early-stage research. As the strategy concludes in 2028, there is an opportunity to build on this foundation by strengthening support for later-stage R&D and addressing priority gaps in health innovations for women. As we mark International Women’s Day, the question is no longer whether women should be included in research, but whether research is delivering the health products that women need. NIH has built the policy architecture to enhance representation, inclusion, coordination, and strategic priority-setting across the research continuum, correcting historical blind spots and reshaping the research enterprise.  Yet inclusion alone does not guarantee innovation. As we look ahead to the future of women’s health research at NIH, continued collaboration will be essential. We encourage NIH to sustain and deepen its engagement with academia, researchers, industry, and civil society as it shapes the next iteration of its women’s health strategy. Building on this dialogue will help ensure priorities reflect both scientific opportunity and real-world need.  GHTC stands ready to partner in shaping what comes next. NIH has made meaningful progress over the past several decades—now is the moment to build on that momentum and work together to drive even greater impact on women’s health in the years ahead. Beyond this strategy, GHTC wants to continue working with Congress to ensure that the progress made at NIH through various avenues is codified into law. By advancing strong, bipartisan policies that strengthen and sustain women’s health research, Congress can protect recent gains and help ensure they deliver lasting impact for patients and communities around the world. As the agency sets its course, we urge decision makers to maintain a strong commitment to women’s health research, including research that advances the development of new priority health technologies for women. The current strategy’s emphasis on foundational and basic science lays critical groundwork for breakthrough products, but translational and later-stage research are equally vital to move promising discoveries across the finish line and into the hands of patients.  This month, and every month, offers an opportunity to reflect on the progress made, the gaps that remain, and the shared responsibility to accelerate a future where investing in and supporting women’s health research is not the exception, but the standard.