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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. 

A research team has identified a protein in the malaria parasite that could offer a promising new target for antimalarial drug development. The researchers found that the protein Aurora-related kinase 1, or ARK1, is essential for the survival and transmission of the malaria parasite. When the researchers turned it off in the lab, the parasite could no longer replicate or complete its development in either humans or mosquitoes, effectively stopping its ability to transmit disease. The ARK1 in malaria parasites is also very different from the version found in human cells, meaning drugs designed to target the protein could be effective without causing harm to humans.  A Phase 3 trial found that a novel single-tablet combination treatment regimen for HIV provided similar viral suppression compared to a multi-pill therapy in older adults, a significant step toward a simpler option for patients who cannot use currently available single-table regimens. The trial included older adults living with HIV who had sustained viral suppression and long treatment histories and remained on complex regimens because of prior drug resistance, intolerance, or other factors that made single‑tablet options unsuitable. The single-tablet regimen was not only similarly effective, but it was also associated with increased treatment satisfaction, as well as improvements in cholesterol and triglyceride levels. Last week, IAVI announcedthat a large Phase 2b trial of the tuberculosis (TB) vaccine candidate MTBVAC will expand to include a new cohort of 1,200 patients who have never been exposed to the Mycobacterium tuberculosis bacterium that causes TB disease. The additional cohort will enable researchers to gather robust safety and immunological data across patients with and without confirmed previous TB infection, increasing understanding of how the vaccine works across diverse populations. MTBVAC is a single-shot vaccine designed to be accessible in remote and low-resource settings; it’s also the only live-attenuated candidate derived from M. tuberculosis currently in trials.

A Phase 2 trial in The Gambia found that a vaccine for enterotoxigenic Escherichia coli (ETEC), a leading cause of diarrheal disease in children in low-income countries, was safe and effective in children between 6 and 18 months old. Cases of ETEC are expected to increase in the coming years due to climate change, and the vaccine under study, ETVAX, the most advanced of the several ETEC vaccines in the pipeline, could help reduce illness and death, lower health care costs, and curb the growing threat of antimicrobial resistance. The vaccine will now advance to a large multicountry Phase 3 trial for further evaluation. A research team at the University of Buffalo has developed an inhalable drug-delivery system for treating tuberculosis (TB), which could reduce the frequency of dosing and lessen side effects. Standard treatment for TB can be lengthy and require multiple drugs, with unpleasant side effects, leading some patients to stop treatment— contributing to the emergence of drug-resistant TB. The new approach involves an inhalable nanoparticle system that modulates the immune system and carries rifampin, a common TB drug, directly to the lungs, where TB bacteria primarily reside. This targeted method contrasts with the pill formulation of rifampin, which, when taken orally, only delivers limited amounts of the drugs to lung tissue. Further studies will explore whether the nanoparticle system can deliver combination treatments, which are the cornerstone of TB treatment, and whether the system can be adapted to address other lung diseases. Ghana recently became the first-ever country to approve a new single-dose combination treatment for soil-transmitted helminths, which cause parasitic infections that affect millions in endemic regions in Africa. The regimen is as safe as the standard drug used in mass deworming campaigns and demonstrates improved efficacy against whipworms, which are often resistant to the single-drug treatment. The medicine is also fruit-flavored, fast-dissolving, and incorporates a novel age-based dosing strategy, making it suitable for children. Administering the two drugs incorporated in the combination treatment previously required between two and six pills per person. 

Dear Representative Neal Dunn and Representative Lori Trahan,  The Global Health Technologies Coalition (GHTC) is pleased to see a bipartisan endeavor to reauthorize the Protecting Americans from all-Hazards Preparedness Act (PAHPA). Since the reauthorization lapsed in 2023, it has been clear that successfully advancing this critical pandemic preparedness legislation requires a bipartisan, bicameral process.  While BARDA’s mission is to advance US national health security, the medical countermeasures (MCMs) developed routinely benefit people around the world. BARDA has advanced at least 93 innovations for antimicrobial resistance (AMR), at least 127 COVID-19 products, and 6 FDA-approved products for filoviruses like Ebola—many of which have been used around the world. As the leading advocacy coalition focused on global health research and development, GHTC wants to ensure the Biomedical Advanced Research and Development Authority (BARDA), through PAHPA, is equipped not only to respond effectively during public health emergencies, but also to make the proactive, forward-looking investments required to stay one step ahead of emerging pathogens.  GHTC Priorities for PAHPA Reauthorization  Require a new 5-year (2027-2031) Strategic Plan for BARDA  BARDA’s current strategic plan ends in 2026, and a new plan is needed to reflect lessons learned from COVID-19, the US mpox response, and the recent outbreaks of Ebola and Marburg in Africa. Requiring BARDA to articulate its goals for the next five years will help ensure strategic alignment with evolving threats. 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, we recommend that Congress direct BARDA to develop it through an open, consultative process that includes input from scientific experts, product developers, and other external stakeholders.  Establish dedicated funding for BARDA’s IEID Division  Although BARDA has created a dedicated Influenza and Emerging Infectious Disease (IEID) program, it lacks dedicated funding. Historically, investments in emerging infectious disease medical countermeasures have come primarily from emergency supplemental funding bills, like those for Ebola, Zika, and COVID-19— reinforcing a reactive, rather than proactive posture. This gap undermines preparedness.   We support the $10 million carve-out for Disease X in recent LHHS appropriations bills and appreciate prior report language that “supports robust funding for BARDA’s naturally occurring infectious disease programs, including emerging infectious diseases, AMR, and pandemic influenza;” however, this remains insufficient to meet preparedness needs. We encourage Congress to authorize $775 million annually for the IEID program, a figure validated by both the agency and external experts as the amount needed to successfully run an EID Division.   Prioritize deliverability in low-resource settings  Limited refrigeration, inconsistent electricity, insufficient sanitation, and constrained health workforce and laboratory capacity can hinder MCM deployment in low-resource settings, both globally and within the United States. For example, these constraints impeded the global and US uptake of first-generation COVID-19 vaccines and therapeutics. Operation Warp Speed was successful at quickly developing safe and effective vaccines, but its leadership told GHTC that deliverability for low-resource settings was not being considered in vaccine portfolio decisions.   To rectify this oversight in future preparedness planning, we recommend that PAHPA:  Require ASPR to conduct a study on factors limiting MCM deployment in low-resource settings in the United States and globally during public health emergencies Authorize BARDA to support national and global community engagement activities as part of MCM development, including support of clinical trial networks. Highlight the necessary capabilities mRNA vaccines provide to BARDA  mRNA is a critical platform technology for advancing the next generation of vaccines and therapeutics, particularly for rapidly mutating pathogens and to enable rapid development when a new disease X emerges. A retreat from mRNA research risks leaving the United States behind other countries, such as China, the United Kingdom, Australia, Germany, and South Korea, who are actively expanding investments in mRNA technologies. It also risks leaving us behind other investing countries in our ability to procure next-generation vaccines for the American people during future pandemics, and could have a reverberating impact if private investors follow suit, widening the innovation gap in our biotechnology ecosystem.  While there is opportunity to improve mRNA vaccines to enhance the durability of protection and reduce side effects, achieving these advancements will require continued investment.   To realize mRNA’s potential, we recommend that PAHPA:  Explicitly authorize BARDA to invest in mRNA platform technology development. Include report language directing BARDA to prioritize mRNA-based countermeasures in its portfolio decisions. Maintain BARDA’s authority to prioritize products for at-risk populations.  The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L. 116-22) and previous reauthorizations enable BARDA to prioritize “children, pregnant women, older adults, and other at-risk individuals” (42 USC § 247d-7e(c)(6)) in the development of MCMs. At a minimum, this language should be maintained to ensure that every American, regardless of age, health status, or circumstance, can access lifesaving medical countermeasures.  Strengthen transparency requirements  BARDA’s improved efforts in publicly reporting on its MCM research investments have been instrumental in supporting innovation, improving oversight, reducing duplication, and fostering collaboration with federal agencies and external partners in global health security. PAHPA should mandate and codify transparent reporting practices across all areas of BARDA investment, including chemical, biological, radiological, and nuclear (CBRN) threats, EIDs, and AMR. This will ensure consistent reporting, regardless of future BARDA leadership changes.  We recommend that PAHPA require BARDA to regularly and publicly report on its product-level investments to the greatest extent possible without compromising national security, and as part of that reporting, to detail the funding amount, threat area, product type, and phase of development for each MCM in its portfolio.  Eliminate the sunset for the Medical Countermeasure Innovation Partnership  The 21st Century Cures Act authorized BARDA to enter a partnership with a nonprofit entity to accelerate MCMs through venture capital practices. BARDA has since entered a successful partnership that has leveraged matched external funding to support at least eight promising innovations. This authority, however, expires on September 30, 2028 (42 USC § 247d-7e(c)(4)(E)(ix)). To ensure continued progress and impact, we urge Congress to eliminate the sunset clause for BARDA’s medical countermeasures innovation partnership authority.  Authorize loan authorities  To support our national preparedness, we urge Congress to establish a BARDA loan authority program modeled after the US Department of Energy's successful approach. This decisive action would better enable BARDA to finance large-scale projects, such as innovative biomanufacturing facilities like those for microneedle patch vaccines. BARDA should mandate a BARDA feasibility analysis to expedite implementation.  Maintain BARDA’s commitment to tackling AMR and advance complementary AMR legislation  AMR threatens the effectiveness of routine medical procedures and drugs critical for treating CBRN and infectious disease threats. Bacterial AMR was directly responsible for an estimated 1.14 million deaths in 2021 and was associated with a total 4.71 million deaths. Deaths attributable to AMR are projected to increase by almost 70 percent by 2050. Without action, annual deaths could reach 10 million globally by 2050, with significant deaths among children and newborns.   BARDA has provided critical support for development of AMR products at every stage of clinical development, but the pipeline of new antimicrobials and other products still remains insufficient to confront this rising threat.  To that end, we urge Congress to:  Reauthorize BARDA’s AMR programs. Leverage the “must-pass” nature of previous PAHPAs to attach and advance other complimentary legislation to spur and incentivize AMR R&D, including the PASTEUR Act and the SUPER BUGS Act if it is reintroduced in the 119th Congress. Conclusion  The next pandemic is not a question of if, but when. PAHPA reauthorization presents a critical opportunity to ensure BARDA has the authorities, resources, and strategic direction needed to keep America—and the world—safer from emerging biological threats. The investments and policy decisions made today will determine whether the United States responds to the next crisis from a position of strength or struggles to catch up while lives hang in the balance.  GHTC appreciates your bipartisan leadership on this essential legislation and stands ready to support your efforts to strengthen America's health security infrastructure. We urge you to incorporate these priorities into the PAHPA reauthorization to ensure BARDA can fulfill its mission of protecting Americans and advancing global health security for years to come.  We welcome the opportunity to discuss these recommendations further and to continue partnering with you on this essential work.  Sincerely,   Dr. Kristie Mikus, GHTC Executive Director