Breakthroughs Blog: BARDA

Amid the ongoing outbreak of the Bundibugyo strain of Ebola—for which there are no specific approved vaccines or therapies—in the Democratic Republic of the Congo and Uganda, the World Health Organization (WHO) has collaborated with outside experts to identify priority Ebola treatments and vaccines for clinical trials. On the treatment side, WHO recommended prioritizing Mapp Biopharmaceutical’s MBP134, Regeneron’s maftivimab, and Gilead Sciences’ antiviral remdesivir. For prevention, Gilead's experimental oral antiviral obeldesivir was highlighted as a priority for post-exposure use in contacts of confirmed cases. IAVI’s rVSV Bundibugyo was identified as the most promising vaccine candidate, but Oxford University and the Serum Institute of India’s ChAdOx1 Bundibugyo vaccine candidate could be available for testing sooner following additional animal testing. WHO is now working with authorities in Congo and Uganda and other partners to design and implement ethical clinical trials during the outbreak. An experimental drug for chronic hepatitis B could potentially serve as a functional cure for the virus, as demonstrated in recently published results from two international studies. For many, hepatitis B only causes short-term illness, but for some, it can become a chronic infection, gradually damaging the liver and, without treatment, leading to liver cancer, liver failure, or even death—it causes around 1.1 million deaths globally each year. Chronic infection requires lifelong therapy in the form of daily pills to reduce viral levels and prevent liver damage, which can be hard to adhere to or access in some countries. Bepirovirsen, developed by GSK and Ionis Pharmaceuticals, was able to reduce the virus in around one in five patients to levels low enough for the immune system to keep it under control without treatment. The drug is under fast-track review by the US Food and Drug Administration, which is expected to make a decision later this year, and is also being considered by international regulators in Japan, China, and Europe. A research team at Georgia State University has developed a promising antiviral drug candidate that could help treat measles, croup, and related viral diseases that cause contagious and life-threatening respiratory infections, as falling coverage of the vaccine for measles, mumps, and rubella raises the risk of infection. The drug, GHP-88310, was designed to be a once-a-day oral pill for vulnerable patent groups, like children and immunocompromised patients, which make up the majority of croup and measles cases. GHP-88310 has been shown to be well-tolerated in rats, mice, ferrets, and dogs at higher concentrations. 

Last week, the Global Health Investment Corporation announced the launch of the Global Health Security Fund, which will strategically invest in companies to accelerate the development of technologies that strengthen global health security. The investments will focus on companies developing vaccines, therapeutics, diagnostics, and enabling technologies with impact and commercial potential, addressing critical gaps in global health preparedness and response. The fund has received support from the US Biomedical Advanced Research and Development Authority (BARDA), as well as investors including the Coalition for Epidemic Preparedness Innovations (CEPI), Flu Lab, Eli Lilly and Company, Meiji Seika Pharma Co., The MITRE Corporation, and the Wisconsin Alumni Research Foundation. A research team at the La Jolla Institute for Immunology has shared promising research that could inform the development of a vaccine that provides protection against a host of viruses in the arenavirus family. Arenaviruses, which are most common in West Africa, are considered to be a viral family with significant pandemic potential and are very similar to hantaviruses, the virus family behind a current worrying outbreak, in how they spread and function. The researchers demonstrated how harnessing T cells could be critical to designing vaccines that can combat many different species of virus at once, an approach that could be applied to other viral families as well. BARDA is working with US-based company Mapp Biopharmaceutical to supply its experimental Ebola treatment for potential use in people who may have been exposed in the current outbreak of Bundibugyo ebolavirus, a strain for which there are no specific vaccines or treatments available. Mapp’s investigational monoclonal antibody treatment was developed through a longstanding public-private partnership supported by BARDA to address Ebola Sudan, which is closely related to other ebolaviruses, Laboratory studies suggest the treatment has the potential to be effective against the Bundibugyo strain. 

Last week, Shionogi announced that its US subsidiary has received a $119 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to boost production and advance development of a key antibiotic, helping improve US preparedness for future outbreaks of drug-resistant bacterial pathogens. Specifically, the funding will go toward the establishment of a US manufacturing site and procurement of cefiderocol, an antibiotic that has the ability to target difficult-to-treat, multidrug-resistant infections, which is already approved for several indications. The award will also fund the development of cefiderocol to respond to high-priority bacterial threats. In a newly published study, a Cornell University research team shared the results of a long-term study that could be a first step toward developing the first safe, reversible, long-acting, and 100 percent effective nonhormonal male contraceptive. In a proof-of-principle study in mice, the researchers targeted a natural checkpoint in meiosis, the reproduction process for sex cells, and were able to safely stop sperm production and, importantly, then recover normal meiosis and complete sperm function, with no impacts on other functions or on offspring. If this approach continues to demonstrate success in further studies, it could eventually be utilized in an every-three-month injection or patch contraceptive product. IAVI recently announced that the first participants have been vaccinated in a Phase 1 clinical trial evaluating the safety and immunogenicity of its investigational vaccine for Marburg virus disease, a highly fatal, high-priority disease, which has been behind a growing number of outbreaks in sub-Saharan Africa in recent years and for which there are no specific approved vaccines. In nonclinical studies, the candidate demonstrated consistently strong efficacy results: a single intramuscular vaccination protected 100 percent against lethal challenge with the virus. IAVI is simultaneously continuing to work with partners in sub-Saharan Africa to ensure the availability of candidate doses for evaluation during future Marburg outbreaks. 

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.