News

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 

A two-year citywide experiment in Singapore found that releasing Wolbachia-infected mosquitoes was effective at reducing mosquito numbers and dengue transmission in the densely populated city, supporting their use as a complement to existing vector control methods and vaccines to control transmission of dengue and other mosquito-borne diseases. Wolbachia is a common type of bacteria found in insects that cannot make people or animals sick but can stop the dengue virus from replicating inside the Aedes aegypti mosquitoes that spread dengue and other viruses, reducing mosquito populations and disease transmission. The researchers divided the city into clusters, releasing sterile infected male mosquitoes in some areas while leaving other areas untouched. They found that where the infected mosquitoes were released, mosquito numbers fell sharply, and people living there were about 70 percent less likely to develop symptomatic dengue after a few months of exposure. A Phase 4 randomized controlled trial has provided further evidence of the safety and efficacy of shortened regimens of preventive tuberculosis (TB), which could help improve uptake and completion rates. The trial, conducted in Brazil, tested one- and three-month regimens of isoniazid and rifapentine, much shorter than the current standard regimen of isoniazid, which lasts six to nine months and has seen poor uptake and completion rates. Additional studies are needed to ensure safety and acceptability across diverse populations. A Stanford University research team has developed an affordable, battery/solar-operated microscope called Octopi that uses artificial intelligence (AI) to automatically diagnose malaria in blood samples in minutes, which could greatly improve access to early and accurate diagnosis in low-resource settings. Confirmatory malaria diagnosis is currently done through a long, technical process carried out manually by lab technicians. The team also developed a complementary tool to automate and standardize the process of preparing blood samples, which is open source, requires no electricity, and is cheap. 

A new study has found that five human cases of a mysterious, bat-borne virus in Bangladesh, initially thought to be Nipah virus, were actually caused by another emerging bat-borne virus called Pteropine orthoreovirus (PRV). Between late 2022 and early 2023, five patients were admitted to hospitals with severe symptoms, all of whom had consumed raw date palm sap, which is also consumed by bats. Health care workers thought they had the Nipah virus, for which bats are a known vector, but they all tested negative. Several of the patients continued to experience severe symptoms after being discharged, and one ultimately died the following year. Human PRV cases have been reported other countries, but typically resulted in much milder respiratory illness, suggesting that the virus may have undergone genetic changes, making it more transmissible and virulent. These findings underscore the need for robust, vigilant surveillance of emerging diseases, particularly bat-borne pathogens. Last week, the Population Council announced that it has executed a global, exclusive license agreement for the Nestorone®/Testosterone (NES/T) male contraceptive gel, transferring the program to Contraline Inc., which will lead late-stage development toward potential global regulatory approvals as the first reversible contraceptive drug for men. The product, if approved, could transform contraception, enabling men to take on a responsibility that has historically fallen on women. NES/T is the most advanced investigational male contraceptive in the pipeline, and the Phase 3 clinical trial being planned is expected to be the first-ever Phase 3 trial of a hormonal male contraceptive. It is a daily topical gel that suppresses sperm production while maintaining normal testosterone levels, which was co-developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health.  An early-stage trial evaluating a nasal spray vaccine for H5N1 bird flu found that the vaccine generated a strong immune response in rodents, a significant first step toward a vaccine capable of slowing the spread of bird flu, which in recent years has continued its worrying global spread among animal populations, with occasional human cases. While traditional injected flu vaccines are highly effective at preventing serious illness, they are less effective at reducing infection in the first place. Nasal vaccines, which work at the place of infection, can more effectively stop infections and prevent onward transmission to others. They are also believed be more effective against rapidly mutating viruses because they train the immune system differently than traditional vaccines, stimulating mucosal immunity in the nose and upper airway, and can respond to features of the virus that are shared across different strains, meaning they can remain effective for longer without needing updating. There are H5N1 vaccines stockpiled in several countries, but most of these were developed to target previously circulating strains of the virus and are poorly matched to the newer, rapidly mutating strains we have seen in recent years.